WO2010017403A2

WO2010017403A2 - Therapeutic compositions, devices and methods for observing treated tissues

Info

Publication number: WO2010017403A2
Application number: PCT/US2009/053021
Authority: WO
Inventors: Leonard S. Girsh
Original assignee: Immunopath Profile, Inc.
Priority date: 2008-08-06
Filing date: 2009-08-06
Publication date: 2010-02-11
Also published as: WO2010017403A3; WO2010017403A9

Abstract

The present invention relates to a therapeutic composition and uses thereof for treatment of damaged tissue. The composition comprises at least one extracellular matrix compound, at least one polar surface active lipid, and a plurality of amino acids having a molar ratio which is characteristic of human breast milk protein. Composition therapeutics also comprises a plurality of amino acids having a molar ratio which is characteristic of human bowel protein and further comprises a fatty acid, gamma- amino butyric acid or L- carnitine. Using FDA approved-as-safe components equivalent to the components of human tissue, composition therapeutics is immunologically concordant with genetic 'self and the immuno-inflammatory barrier and thereby avoids crossing and activating the immuno- inflammatory barrier.

Description

THERAPEUTIC COMPOSITIONS, DEVICES AND METHODS FOR OBSERVING TREATED TISSUES

FIELD OF THE INVENTION

The present invention relates to a non-invasive medical therapy, and compositions for avoiding organ transplantation, reducing rejection of transplanted organs, or treating organs under consideration for replacement by transplant, and otherwise treating aged, diseased or abnormal tissues and organs. The composition and methods of the invention may also be used to augment the treatment of multiple diseases and disorders of the body such as and inclusive of dermatological disorders, gastrointestinal disorders, ophthalmic disorders (such as diseased corneas), neurologic disorders, bacterial infections, respiratory disorders, tracheo-bronchial disorders, and various disorders related to aging. The present invention involves administering to a patient a therapeutic formulation comprising a free L-amino acid non- chiral glycine profile, simulating or replicating the proteins normally present in healthy tissue that is now diseased or transplanted tissue. The invention also relates to therapy involving administration of therapeutic formulations comprising free L-amino acids in which the molar ratios of the amino acids correspond to the ratios of components such as amino components in a medication that is useful for treating a disease. By simultaneous administration of the various components of one of the therapeutic formulations, the components are able to work synergistically to restructure diseased tissue and organs. The invention also relates to providing pharmacologic mechanisms for this synthesized therapeutic biologic, that becomes activated in-vivo as a therapeutic agent in restructuring diseased tissue. The pharmacologic mechanisms provided are not only anti-inflammatory, but also tissue healing, mediated by the foregoing composition's organizational matrix and matrices therapeutic intervention, to therapeutically enable diseased tissue to meet the dictum that DNA, RNA templating provides for protein synthesis by providing the interventional raw material such as L-amino acids and glycines specified by the genetic code of the targeted protein. At first believed to be epigenetic, it is now believed to be also a genetic therapeutic opportunity to non-invasively modify the genetic cycle without crossing immuno-inflammatory barrier with introduction of DNA, RNA and protein macromolecules that would induce cytokine inflammatory reactions. This now provides DNA, RNA, amino acids protein synthesis stimulating therapeutics to provide healing protein. Healing is dependent upon the resolution of inflammation synergistically co-existing with healing tissue repair and regeneration, all becoming activated therapeutically in-vivo. This imunologically privileged therapeutics crosses species barriers and cell lines. This multiplicity of species barriers' adaptation is evidenced by disease resolution in pre-clinical studies in equine animal health therapeutics. This inventive synthetic biologic therapeutics thereby provides the activation of the patient's own stem cells non-invasively, providing repair, regeneration and disease resolution applicable even to diseases of poor prognosis. This invention further provides the same molecular embryologic mechanisms to synergistically provide the embryogenesis involved in healing, cell and tissue repair and regeneration in disease reversal,. The invention also relates to providing therapeutic immunologic 'self as a bio-chemically invisible therapeutics that also has the pharmacologic dynamics of significantly reducing the inflammatory cytokine chemo- attractant mediators, as well as providing anti-inflammatory interleukin receptor antagonists.

This bimolecular epigenetic and genetic activation of the patient's own stem cells in cell/tissue healing, referred to as immuno-therapeutics, can be brought about by a newly discovered biomolecular composition that can reverse and provide resolution for diseases of poor or guarded prognosis.

Further, new instrumentation described herein will provide tracking of the therapeutic response, as well as the potential of biopsy-like diagnoses, measured by the degree of hydrophilicity of the phospholipids, L amino acids, glycine and extracellular matrix polar surface lipid active components. These therapeutics mimics normal human and mammalian tissues' degree of birefringence with polarized light. This in turn offers the potential of measuring, with a probe, a screening test for abnormal tissue, exemplified in diseases such as cancer, which lack the birefringence and its associated molecular and tissue structural organization. The subject invention also pertains to the visualization of wound and/or tissue healing, utilizing polarizing light microscopy technology.

BACKGROUND

The present invention is useful for the treatment of many disorders, particularly tissue or organ failure (such as kidney or liver failure), corneal disorders, gastrointestinal disorders, and dermatological disorders. Presently, many of the methods of therapy for these disorders involve invasive surgical methods, such as organ transplant in the case of extreme tissue damage. Organ transplantation involves many risks, such as complications resulting from the anesthesia and surgical procedures, side effects from medications, such as cyclosporin, which help prevent organ rejection, and the risks of blood borne pathogens or shock if transfusions are needed. Moreover, organ transplantation is very costly. The present invention functions to treat disorders with a therapy that has minimal risk of complications, low cost, and no serious side-effects. The present invention concerns useful therapeutic formulations having a plurality of

L-amino acids and non-chiral glycine present in molar ratios also corresponding to either (1) the ratio of the amino constituents in normal tissue or normal organs, or (2) the constituents found in a medicinal compound useful for treating a medical disorder. Furthermore, Applicants have discovered that relatively low amounts of this therapeutic formulation comprised of L-amino acids, such as a daily intake of about 10 grams or less for an adult, are sufficient for therapeutic effect. The invention can be used with many medical disorders, preferably to avert the need for organ transplants, to treat the biological rejection of a transplanted organ, or prophylactically after transplantation before rejection occurs to reduce the risk of organ rejection. In one embodiment, the therapeutic formulations of the invention are administered for pre-operative optimal care where considerations for surgery have not been finalized. In one embodiment, the therapeutic formulation components simulate the chemical components in cyclosporin.

Elemental feedings containing free amino acids are known as substitutes for milk allergies or milk intolerance, such as in infantile asthma, eczema, or colic. The following articles disclose such uses, all of which are incorporated in their entirety herein by reference: Beyond hydrolysates: Use of L-amino acid formula in resistant dietary protein-induced: intestinal disease in infants, Lake, A. M., J. Pediatrics, 131 :658-660 (1997); Intolerance to protein hydrolysate infant formulas: An under-recognized cause of gastrointestinal symptoms in infants, Mack, D. R, Antonson, D. L., Corkins, M. R., Perry, D., and Kruger, R., J. Pediatrics, 131 : 741-744 (1997); Allergy to extensively hydrolyzed cow milk proteins in infants: Identification and treatment with an amino acid-based formula, DeBoissieu, D., Matarazzo, P., and Dupont, C, J. Pediatrics, 131 :741-744 (1997); and Efficacy and safety of hydrolyzed cow milk and amino acid-derived formula in infants with cow milk allergy, Solauri, E., Sutas, Y., Makinen-Kilguncn, S., Oja, S. S., Isosomppi, and R., Turjanmaa, K., J. Pediatrics, 131 : 550-557 (1997). Elemental feedings are also known to be useful for treatment of gastrointestinal conditions, such as Crohn's disease (regional ileitis), as noted in the following article, which is incorporated herein in its entirety by reference: Treatment of active Crohn's disease by exclusion diet: East Anglian multicentre controlled trial, Riordan, A. M., Hunter J. O., Cowan, R. E., Crampton, J. R., Davidson, A. R., Dickinson, R. J., Dronfield, M. W., Ellows, I. W., Hishon, and S., Kerrigan, G. N., et al, Lancet, 342 (8880): 1131-34 (Nov. 6, 1993). In the present invention, much smaller dosages of L-amino acids are used than are found in elemental feedings. Furthermore, the inventive compositions contain specific molar ratios of L amino acids for a given disease or to mimic therapy with a given medicament.

The present invention is particularly useful for the medical treatment of congenital biliary atresia, which is the most common cause for pediatric liver transplantation. Congenital biliary atresia has been a fatal disease if not treated surgically with liver transplantation and the Kasai procedure. Past research suggests that congenital biliary atresia is caused by the following: (1) hypersensitivity immunopathy; (2) viral infection—hepatic: and (3) inflammation due to (1) and (2). Eosinophiles present in early stages are suggestive of possible hypersensitivity. In the article entitled Contribution of Hepatic Parenchymal and Nonparenchymal Cells to Hepatic Fibrogenesis in Biliary Atresia, Ramm, Grant A., Nair, Visalini G., Bridle, Kim R., and Shepherd, Ross, W,, American Journal of Pathology, 13(2)L 27-35 (August 1998), which is hereby incorporated herein in its entirety by reference, it is disclosed that extrahepatic congenital biliary atresia is a severe neonatal liver disease resulting from a sclerosing cholangiopathy of unknown etiology. Although biliary obstruction may be surgically improved by a "Kasai" hepatoportoenterostomy, most patients still develop progressive hepatic fibrosis and cirrhosis. Although the source of increased collagen deposition is unclear, an article entitled Prognostic value of serum procollagen III peptide and type IV collagen in patients with congenital biliary atresia, Kobayashi H., Mayano, T., Horikoshi, K., and Tokita A., J. of Ped. Surgery, 33(l):112-4 (January 1998), which is hereby incorporated herein in its entirety by reference, discloses that progressive hepatic fibrosis, in spite of a successful Kasai procedure, is a major problem in patients with congenital biliary atresia. N-terminal procollagen-III peptide (PIIP) (which is a marker of fibrogenesis, and therefore, of ongoing inflammation), and type IV collagen (found in basement membrane extracellular matrix), were measured in patients with congenital biliary atresia to determine their potential as prognostic markers. Long-term follow-up of patients with congenital biliary atresia successfully treated with hepatic portoenterostomy: The importance of sequential treatment, Lopez-Santamaria M., Gamez M., Marcia J. Diez-Pardo, J., Diaz, M., Leal, N., Lobato R., Martinez, L., Hierro, L., Camarena C, De La Vega A., Frauca E., Jara P., Barrocal, T., Prieto, C. Coretes P., and Tovar, J., Ped. Surgery International 13(5-6):327 (July 1998), which is hereby incorporated herein in its entirety by reference, discloses long-term follow-up of patients with congenital biliary atresia who have been treated with hepatic portoenterostomy. As to the importance of sequential treatment, the authors concluded that the natural outcome of extrahepatic biliary atresia is toward fibrosis, and cirrhosis, even in those cases successfully treated with hepatic portoenterostomy (HPE).

Urinary 7alpha-hydroxy-3-oxochol-4-en-24-oic and 3-oxochola-4,6-dien-24-oic acids in infants with cholestasis, Kimura, A., Suzuki, M., Murai, T., Kurosawa, T., Tomna, M., Sata M., Inoue, T., Hoshiyama, A., Nakashima E., Yamashita, Y, Fujisawa, T., and Kate, H., J. of Hepatology, 28(2):270-9 (February 1998), which is hereby incorporated herein in its entirety by reference, discloses that urinary 3-oxo-delta4 bile acids have been detected in infants who ultimately died of liver disease. The results reported in this article suggest that an increase in the 7 alpha-hydroxy-3-oxochol-4-en-24-oic acid and 3-oxochola-4,6-dien-24-oic acid in the urine of patients with hepatobiliary disease indicates a poor prognosis. The first cooperative living-related donor liver transplantation performed by two separate institution teams: The Kanaqawa Liver Transplantation Program, Ohhama, Y., Shinkai, M., Fujita, S., Nishi, T., Yamamoto, H., Torigai, K., Takemiya, S., Sugimasa, Y., Akaike, M., and Tanabe, H., Surgery Today, 28(2): 173-7 (1998), which is hereby incorporated herein in its entirety by reference, is a study of living-related donor liver transplantations. The study involves five children with congenital biliary atresia who were given partial liver grafts obtained from their mothers in January, 1995.

Portal vein reconstruction in pediatric liver transplantation from living donors, Saad, S., Tanaka, K., Inomata, Y., Uamoto, S., Ozaki, N., Okajima, H., Egawa, H., and Yamacka, Y., Annals of Surgery, 227(2):275-81 (February 1998), which is hereby incorporated herein in its entirety by reference, discloses that in living related partial liver transplantations, portal vein anastomosis to the confluence, with or without the use of vein grafts, is an optional alternative to end-to-end reconstruction, especially in small children.

Soluble ICAM-l (Sicam-1) in congenital biliary atresia, Minnick, K. E., Kreisberg, R., and Dillon, P. W., J. of Surgical Research, 76(1), 53-6 (April 1998), which is hereby incorporated herein in its entirety by reference, discloses that SICAM-1 (Soluble Intercellular Adhesion Molecule- 1) is markedly elevated in congenital biliary atresia, reflecting the immunopathology of the disease process, but it does not appear to correlate with markers of liver function. SICAM-I may be useful in assessing the effects of immunomodulatory therapy.

Diverse morphology of biliary atresia in an animal model, Petersen, C, Grasshoff, S., and Luciano, L. Journal of Hepatology, 28(4): 603-7 (April 1998), which is hereby incorporated herein in its entirety by reference, discloses diverse morphology of congenital biliary atresia in an animal model and relates the findings to congenital biliary atresia in children. Extrahepatic congenital biliary atresia can be simulated in Balb/c-mice which have been infected with a rotavirus. Irreversible occlusion of the common bile duct is the result of an inflammatory process of the whole biliary tract. The observations in this animal model are analogous to observations of extrahepatic congenital biliary atresia in newborn children. This original model can be used to help determine the minimal therapeutic dose required of the present invention per animal weight of this nutrient therapy (similar concept to toxicologic studies for minimal lethal dosage). These studies suggest that most types of extrahepatic congenital biliary atresia in children can be mimicked in an animal model. Neurodevelopment outcome of young children with extra hepatic congenital biliary atresia 1 year after liver transplantation, Wayman, K. L, Cox, K. L., and Esquivel, C. O., Journal of Pediatrics, 131(6):894-8 (December 1997), which is hereby incorporated herein in its entirety by reference, stresses that urgent nutritional therapy is a preventive measure for development delay. A case series of transplant recipients who despite immuno suppression developed inflammatory bowel disease, Riley, T. R., Schoen, R. E., Lee, R. G., and Rakela, J., American J. of Gastroenterology, 92(2):279-82 (February 1997), which is hereby incorporated herein in its entirety by reference, discloses a small number of patients who developed inflammatory bowel disease (IBD), including Crohn's Disease, after solid organ transplantation, one of which had pre-transplantation diagnosis of congenital biliary atresia, despite use of immunosuppressive therapy.

Congenital biliary atresia is similar to infantile asthma; the asthma and associated inflammation and edema occur in the tracheo-bronchial tree, whereas in congenital biliary atresia, the shock organ and associated inflammation and edema occur in the biliary tree. In a preferred embodiment, the method and composition of the present invention treats congenital biliary atresia without resulting in cirrhosis or inflammatory bowel disease, two common ailments suffered by children having received conventional therapy for congenital biliary atresia. The first in-vitro studies have been provided by providing the pharmacologic mechanisms of significantly reducing the inflammatory cytokine chemo-attractant, mediators, as well as providing anti-inflammatory interleukin receptor antagonists by incubating Crohn's diseased tissue and normal bowel biopsy tissue as a control. Measuring reduction in interleukin levels of inflammation (ILl) as well as the antagonists of inflammation (ILl receptor inflammatory antagonists) was performed by two institution teams: Shand, Marian, Meister, Doris, et al, Direct Anti-inflammatory Effect of Elemental Diet on Crohn 's Tissue in- Vitro. Gl Laboratory, Dept of Medical Sciences, Univ. of Edinburgh Western General Hospital, Edinburgh.2000; and Meister, D et al. Anti-inflammatory Effects of Enteral diet Components on Crohn 's Disease-affected Tissues in Vitro. 2002. UK. Which is here by incorporated here-in in its entirety by reference. This correlates with our findings presented in the series of filed patents, following 6, 974,796 Bl, where in the analog biologic structure of the amino acids to their respective propionic acid, butyric acid and three aromatic amino acids with many of the existing anti-inflammatory bio-chemicals such as ibuprofen are presented in detail in section (3a.), Uses and Pharmacologic Mechanisms of Antiinflammatory Activity.

The multiplicity of affects of these components of therapeutic subject composition, such as amino acids, are further included in functioning not only in stimulating protein synthesis, but also in providing neurotransmitter activity. Certain amino acids are central neurotransmitters, especially, GABA (gamma amino butyric acid), glycine and glutamate. Dicarboxylic amino acids, such as glutamate have neuro-excitatory effects and the monocarboxylic amino acids such as GABA, glycine, B-alanine (beta alanine) and taurine, produce inhibition. Similar multiplicity of bio-chemical effects are seen with current medication in the PDR. Some are specific effects and some are unwanted side-effects. These components may be utilized for their beneficial effect without the trade-off of the multiplicity of side-effects in medication such as corticosteroids. Along with their neurotransmitter effects, these amino acids have a specific effect of tissue healing and repairing of cell, tissue and cell membrane defect. Also, these amino acids such as aromatic amino acids, tryptophan, tyrosine and phenylalanine act as a source of such neurotransmitters as serotonin epinephrine, non-epinephrine DOPA (di- hydroxyphenalenone).

Presented by Goodman & Gilman's Pharmacological Basis of Therapeutics. McGraw Hill, New York, US & Oxford, UK. 2001 p.304; which is herein incorporated herby in its entirety by reference. Waltman NL, et al. Nutritional Status, Pressure Sores & Mortality in Elderly Patients. 1996. University of Nebraska Medical Center, College of Nursing, Omaha (17/20 patient care studies) hereby incorporated herein in its entirety by reference discloses decubitus ulcer (the "Christopher Reeves" syndrome) pressure sores related to protein deficiencies in the wound healing of decubitus ulcers in elderly nursing home patients with and without cancer predisposition. They found that 28 cancer patients had developed pressure sores versus 23 non cancer patients. 23 out of 33 patients developed Kwashiorkor (significant blood albumen protein deficiency) versus 6 out of 33 patients that had developed Kwashiorkor. In 12 weeks, 12 out of 28 (almost ½) of the cancer patients died versus the 4 out of 23 (1/6) of the nocancer patients that died.

Subject inventive immunotherapeutics is defined as an immunologic broad based and diverse range of therapeutic applications. The treatment of disease and damaged tissue from a fresh tissue healing vantage point. This molecular medicine replication of human tissue and the underlying molecular embryology of the most advanced principles of proteomics applied to immunotherapeutics would be those of the subject application. As a result, this therapeutics is immunologically privileged and adapts well to crossing the multiplicity of species barriers as well as disease cell lines. The use of advanced proteomics in protoplasmic protein advanced healing in conjunction with redirecting and noπnalizing the persistent and aggressive immuno-inflammatory response system, resulting in a significant increase in anti- inflammatory receptor antagonists along with equivalent decrease of inflammatory protein interleukins (cytokines). This FDA approved therapeutics is a steroid sparing/ substitute applicable as a stem cell stimulant growth factor to the many disease systems of the body such as, but not limited to, wound healing inclusive of deep penetrating wounds, inflammatory bowel disease (IBD), bronchial asthma, neurodegenerative diseases such as Parkinson's disease, Alzheimer's, multiple sclerosis (MS), cardiovascular disease and atherosclerosis.

The immunotherapeutic agent (IA) of the subject invention is able to provide the body tissues with the repair components required for disease resolution, even in diseases of poor prognosis. This includes healing of damaged tissue due to injuries. The IA of the subject invention can activate the patient's own healing system and associated stem cells that have been deactivated by disease or trauma. The subject IA, FDA approved bio-material composition, provides repair and regeneration of diseased tissue resulting in disease resolution. Healing is the paramount mechanism unique and exciting to this therapeutics to overlap and provide normalized cell cycle protein synthesis of healing anti-inflammation of healing and steroid sparing/substitution of IA' s healing capacity.

The subject immunotherapeutics can be directed to the following markets focused upon trauma and its potential complications of persistent tissue damage and inflammation. Traumas presented in the ER and the surgical suite, also evident in sport medicine and arthritis, have a total current published market estimates of approximately $650 Billion. Trauma: $260 Billion, Sports Medicine: S133 Billion, Arthritis: $128 Billion and Infectious Disease: $120 Billion. (Sources of comparative relative market value include Wikipedia, Women's Health Resource and Investor's Business Daily) is subject of further extensive study. Similar findings have been noted in the arthritic care (included in arthritic diseases of poor prognosis) estimated annual U.S. costs and market value for animal veterinarian care of about $20 billion total comprising $10 billion veterinarian care and $9.8 billion for supplies and over-the-counter medicine.

Animal studies including equine veterinarian studies this also provides a methodology for drug discovery by co-using in the therapeutics of an existing veterinary disease, At the same time this represents a methodology for drug discovery, not limited to disease presented and treated here, in animal testing useing an existing analog disease model such as, but not limited to, sports medicine. This was accomplished without experimentally producing a diseased model in an animal, representing an ethical and humane advance in drug discovery as well as a significant economic advantage in greatly minimizing the costs that are escalating in drug development by accomplishing three beneficial therapeutic effects at the same time that further includes a secondary market, veterinary medicine.

It is believed this inventive subject composition immunotherapeutics provides the activation of protein synthesis and proteomics, an essential component of healing, associated proteomics of protein polymerases of DNA and RNA, and the patient's own stem cells non- invasively. The anti-inflammatory immunotherapeutic efficacy is associated with reduction in release of inflammatory cytokines and chemo-attractants as well as an increase in the biochemical antagonist to protein interleukin inflammatory receptors associated antiinflammatory efficacy. This subject composition therapeutics thereby provides a therapy for the elderly confined to nursing homes with the therapeutic opportunity of preventing and reversing the very serious complication of decubitus pressure sores.

The 3-D stereochemistry of therapeutic compounds as amino acids without side effect and basis for stimulation of protein synthesis essential for healing and wound healing associated with alpha amino carbon and tetrahedral fit, the L amino acids and non-chiral glycine specified by the genetic code of protein and therapeutically targeted protein including anti-inflammatory efficacy by 3-D fit into protein and its synthesis including aromatic benzene ring containing amino acids such as L tyrosine L phenylalanine L tryptophan. In contrast to the 3-D sliding effect of one benzene ring upon the other as the case with aromatic benzene ring NSAID compounds is believed to explain the aromatic benzene ring containing NSAID non-steroidal anti-inflammatory drugs 3-D stereo chemical interference with protein synthesis and healing. This concurs with 20 recent studies: recommending avoidance of NSAID wound healing further evidence for this benzene ring misfit in the stereochemistry of therapeutics as applied to drug efficacy and safety and maximizing and optimizing efficacy and safety in new drug discovery.

This 3-D stereo chemical misfit can be further conceptualized in terms of the resulting from this misfit in the form of metabolic intolerance that we have progressively discovered in regard to trans fatty acid fats a product of hydrogenation design based on 2-D chemistry. As a result, this clinical medicine 3-D stearic stereo chemical misfit, acting as a biochemical molecular foreign body, was originally mandated to be removed from the marketplace by the country of Denmark. Denmark makes great strides in food chemistry and through their leadership, has been taken off the market throughout the world. The 3-D stereo fit provides added knowledge in tracking the potential of a 3-D integrative misfit in the case of drag reactions and intolerances. The L amino acid, levo dopa (L tyrosine with an extra adjacent hydroxyl group), can traverse the blood brain barrier. In the management of Parkinsonism, however, when decarboxylated into its active neurotransmitter amine form, it has not been found useful therapeutically. This is because it cannot cross nor have a stereo 3-D fit to traverse the blood brain barrier as required in this treatment. This example further illustrates the remarkable, flexible, adaptable fit, found in this subject composition therapeutics: the L amino acids and glycine specified by the genetic code of targeted protein essential component in contrast to the amine, a product of simply removing the carboxyl group of the amino acid.

In enhancing therapeutics through cell biology models, we find we are imaging cell and tissue surface and a biologic model of conceptualization and visualize a cell tissue 3-D stereochemistry as a micro-cosmonaut. This will help to best conceptualize the above 3-D stereochemistry necessary to advance this subject composition therapeutics, advancing new drug or food component discovery, to enhance enzymatic metabolic homeostatic equilibrium. Clinically integrated cell biology further provides important second messenger final pathway of pharmacologic signaling of cell biology in mediating this therapeutics. This therapeutics also provides normalization of neurotransmitter signaling applicable neurological Iy. Preclinical findings also provide for this anabolic remyelination therapeutic opportunity.

The importance of correcting deficiencies associated with disease, are being stressed here. These are deficiencies found in the UK of children with Crohn's disease, which composition U.S. Patent Mo. 6,974,796 Bl (hereby incorporated by reference in its entirety)addresses. In fact, wound healing the process of which has been well-studied is based on replication of human or other mammalian tissue biochemically. This has been found to also replicate the molecular medicine of the healing system stem cell and molecular embryology. This can be summarized by the activation of the phosphatidyl choline, phospholipid of the cell membrane of the egg by sperm penetration fertilization, which in 3-5 minutes has been shown by, experimentally radioactively tagged amino acids to activate the metabolically sleeping egg and initiate the incorporation of these existing free amino acids into protein. Similarly utilized in this inventive therapeutics inclusive of twenty free amino acids specified by the genetic code of template protein and cell membrane essence phospholipid such as phosphatidyl choline. Within 1 -2 hours the extracellular matrix (ECM) links the cleaved cells together. This is similarly utilized in this inventive therapeutics to impart a glycosylated tissue tracking biomarker along with a highly sulfated ECM analogist biochemically, eg. to the sulfated nylon polymer of bullet proof vest material of Kevlar. This has been shown by Prudden (Prudden JF, Allen J. The Clinical Acceleration of Healing with a Cartilage Preparation. JAMA. 1965; 192 (5): 352-356) to increase the tensile strength of healing tissue by 42%. This is synergized by the micronutrients such as, but not limited to, the coenzyme activity, and in the case of vitamin D now believed to be hormone-like antioxidant activities of the vitamins similar actions of the minerals including catalytic activity.

The normalization of the mitochondria tissue energy pack from an evolutionary stand point is believed to be derived from micro-organisms, (see J.Brachet & H.Alexandre, Introduction to Molecular Embryology, Springer- Verlag Berlin Heidelberg, 1986 pg.18, which is incorporated herein in its entirety) The normalization of the mitochondria is of practical therapeutic use as we have shown, in that with the use of phospholipid, specifically egg yolk phospholipid, normalization of the patient's energy level in end-stage cancer (available by Abbott Laboratories as Liposyn as well as a similar FDA approved product Intralipid made by Baxter Healthcare Corp., Deerfield, IL). This is in conjunction with existing therapy whereby patients within 24-48 hours felt that their energy level was normal and they were able to go home rather than going to hospice or remain in the hospital. This correlates with microbiologist, Warburg's studies presented at his Nobel prize presentation, in that the metabolism of mitochondria of the human cancer cells had reverted to the metabolism of the micro-organism at 10% of the aerobic energy level of normal human tissue. (Leonard S. Girsh, M.D., Lipid Containing Compositions and Methods of Using Them, US patent 2007/0037777 Al, Feb.15, 2007 (in-vivo studies) The comparison of the more efficient aerobic energy release of human and other mammalian tissue, (see Piel, Gerard. The Age of Science. Basic Books 2001 New York, NY. Pages 285-286, which is incorporated herein in its entirety),) repair and tissue regeneration, which are dependent upon not only correcting and adding an adequate supply of these components, but all the components of 6,974,796 Bl. These include amino acids, vitamins, minerals, of the elemental feedings and specific profiles of targeted tissue protein along with extracellular matrix. In fact diseases have been reported to be diagnosable by deficiency biomarker patterns. This is exemplified by neurodegenerative diseases such as MS. Parkinson's disease and Alzheimer's associated with the unique reduction of uric acid deficiency biomarker.

This therapeutic subject composition foπnulations, in mimicking human tissue, incorporates therapeutically and simultaneously offers the bio-environment component correction of deficiencies. It has been found to successfully resolve diseases of poor or guarded prognosis such as, but not limited to, diseases requiring organ transplants, joint prosthesis, skin grafts, Crohn's disease, and more recently, cancer. This includes ectodermal healing as applied in wound healing. (Pediatric Surgical Care) These bio-chemicals are used to not only replicate human tissue and other mammalian tissue with their healing capacity, but also incorporated bio-robotically, to aid damaged tissue in its function as normal tissue, as well as to activate and mobilize stem cells. This stem cell stimulant growth factor and its bio-robotics can best be illustrated by self vesiculation of phospholipid such as phosphatidyl choline in cell, nuclear, and organelle membrane formations. The final composition-of-matter, when used transdermal^, orally, or intravenously, can also activate patient's tissue synergistically. thereby, facilitating, accelerating and stimulating, therapeutics to most importantly function as an equivalent therapy to cell-based therapeutics provided as healing stem cell tracking biomarkers. Once tissues have been activated, understanding and even directing the mechanisms that effect such tissue normalization and healing can be facilitated by the use of polarizing light microscopy. Inclusive of best visualization of in-vitro fertilization and meiotic spindle formulation with the diagnostic and therapeutic tracking as measured by degree of birefringence is evidence of membrane phospholipid adequacy of the meiotic spindle.

It is further believed in mitosis and more so abnormal mitosis of cancer wherein (1) absent nuclear membrane, (2) nucleolar membrane and nucleolus and (3) DNA chromatin condensation, too dense to function as templating agent. This is associated with deficiency shortage of phospholipid, such as phosphatidyl choline necessary for normal spindle formation and preventable histopathologic finding of characteristic cell of cancer of being "stuck" in mitotic division such as anaphase. It is believed detectable that this phospholipid deficiency is detectable as deficient by inventive subject instrumentation polarizing microscopy readout. (Further described with therapeutic application of addressing and normalizing hydrophilic phosphatidyl choline deficiency Leonard S. Girsh, M.D., Lipid Containing Compositions and Methods of Using Them., US patent 2007/0037777 Al , Feb.15, 2007 (in-vivo studies) and Leonard S. Girsh .M. D., Therapeutic Composition for Treatment of a Damaged Tissue, US patent 2005/6, 974, 796 Bl Dec.13, 05)

This further confirmation of phospholipid deficiency in cancer has been further traceable and tracked diagnostically in patients receiving elemental feedings: amino acids, micronutrient vitamins and minerals without the addition of phospholipid such as phosphatidyl choline, leading to hepatic precancerous preneoplastic mutagenicity. These findings have been found to be readily reversible in humans with phospholipid replacement. In an animal experiment rats fed a choline deficient diet, foci preneoplastic hepatocytes appear in the rat liver, and hepatocellular carcinomas occur at approximately 12 months. The multiplicity of functionality in addition to acting as a hydrophilic moiety as a hydrophilic surfactant phospholipid, phosphatidyl choline; choline being a trimethylamine has methylating capacity similar to B 12, folic acid, B6, B2, riboflavin along with the methylating capacity of trimethylglycine. These compounds and methylating capacity thereby have the ability to reverse a deficiency like condition of homocysteine acting as a pathogen rather than the normal amino acid that it was derived from. Thereby, rendering pathogenic homocysteine reversibly to an essential amino acid methionine as well as a sulfur containing amino acid cysteine. (B. F. Szuhaj,and S.H. Zeisel, "Choline, Phospholipids, Health, and Disease^'" SOCS Press, page 21 & 22 along with cited references 86-98) Another deficiency that we have tracked provides disease reversibility: this dual opportunity for two sites to heal the (1) wound and (2) chronic Crohn's disease by a dual method of administration; transdermal and systemic oral subject composition treatments were used here and have been cited in detail. The poor healing qualities of the tissues and organ systems of the body inflammatory bowel disease can be reflected visualized focused on the open wound and its associated loss of extracellular matrix tensile strength that determines not only its ability to resist trauma but also its ability to heal through this therapeutics is aimed to correct. This healing system can be therapeutically directed when the disease was focused on the trauma and poor healing qualities of the skin secondary to the interference of healing by steroids and by the intensity, aggressiveness and persistence of the immuno inflammatory system production of inflammatory interleukin and cytokine protein chemicals (for pediatric and adult IBD). Prolonged use of steroids for the management of Crohn's Disease represented the rationale for the inability of this wound to heal. This prompted the plastic surgeon, in our discussion, to defer a full thickness skin graft which would have resulted in two major wounds unable to heal, the patient's graft donor site, and her own graft site, in this case. Thus, the subject composition's steroid sparing had two significant therapeutic benefits, accelerating wound healing and averted a full thickness graft (with the association of two wounds that would be at-risk of healing). Additionally, the subject composition's wound healing therapeutics maximizes and optimizes wound healing response, thereby providing the epitome of wound healing resulting in a scar-free healed wound. This emphasizes drug efficacy and safety in tissue repair, regeneration, and revitalizing tissue to heal through the subject compositions immunotherapeutic agent (IA) regenerative medicine.

In conclusion: This includes the ability to provide tissue tensile strength, resilience, and thereby the ability to best resist trauma of importance in sports medicine and even of more important of everyday living. This immunologically privileged therapeutics provides anabolic healing and disease resolution, while simultaneously providing biologic competition which provides both tissue antagonism and resistance against invasive micro-organisms. This therapeutics also provides protective effect to resist other etiological factors such as carcinogens. In 2001, the inventor accompanied this patient to the plastic surgeon, the surgeon stated "it looks as if you were hit with an ax." This wound was sustained secondary to spiking herself with the heel of one shoe against the other leg, (similar to the spiking injuries seen in sports medicine such as a baseball player sliding into second base). Upon inspection of the wound it appeared as if her tissues fell apart, secondary to deficiencies, resulting from aggressive, persistent inflammatory chemical protein interleukins released by immunocytes due to prolonged Crohn's disease further clarifying the plastic surgeon's description. A significant component of these deficiencies is associated with gastrointestinal flare-ups of diarrhea every one to two months of more than 3-6 diarrheal explosive bowel movements per day, representative of significant tissue and tissue fluid loss with resultant deficiencies requiring large daily dosages of steroids, as much as 4-6 tablets (4mg each of Aristocort, Lederle then Fujisawa) which furthered the deficiency interference with healing. Dosage of steroid were progressively reduced: every one to two day by one tablet and then maintenance of one to two tablets daily. Additionally, work of Sanderson shows that elemental feedings reduced abnoπnal intestinal permeability with associated hourly and daily tissue fluid loss contributing even further to the deficiency state as seen with this wound. This preventive therapy provided: (1) functional and gross structural revelation of the equivalent of tissue inadequacy, in that the tissue fell apart. This deficiency of tissue loss, as sited above, to withstand and resist the trauma of the inflicted wound further provided the development of IBD, Crohn's disease therapeutics as well as countering the deficiency. Of this subject composition therapeutics, the extracellular matrix (ECM) would be the most significant (but not limited to) deficiency in that the tensile strength of tissue does not have the ability to maintain the 42% tensile strength to hold the tissues together. This is analog to the molecular embryology stem cell's healing capacity representing the ECM in uniting cells after cleavage. The experimental molecular embryology in sea life of the sponge embryo falling apart after cleavage is the cell biology analog to the above wound. This occurs when, experimentally, a millipore filter removes the ECM, only to be reformed in two hours so that the cells can reunite. This patient is no longer prone to wounds that fail to heal nor to a bowel that fails to heal. Since recovery she has been impressed with the necessity to maintain therapeutics of GIR 1 14P and requires 3 ½ tablets of steroids weekly without flare-ups formerly requiring the foregoing extensive dosages of steroids. In the past year she is receiving 2 ½ tablets of steroids, (see Figure 10.B) The importance of the ECM for multi-cellular tissue formation is emphasized here by the production of collagen, laminin and fibronectin as early as cleavage of the fertilized egg and represents the integrated essence of tissue. This tissue union is not an inert glue. The ECM contains software-like information which can direct organization of cells attachment differentiation and intracellular and intra-tissue signaling. This synergistic final link of ECM of cells integrated into tissue is important not only for wound healing but growth and development.

Although not often utilized, and often undervalued as an investigative tool, polarized light microscopy can provide the benefits of bright-field microscopy, in addition to a variety of other information, which is simply not available with any other optical microscopy technique.

This procedure can also provide information on absorption, color and boundaries between materials and tissues of differing refractive indices obtainable in brightfield microscopy, polarized light microscopy can distinguish between isotropic and anisotropic materials. By exploiting the optical properties of anisotropy, detailed information, as is believed non- invasively, about the living cell and tissue not requiring stains. Structure and composition of materials can be obtained, which can be invaluable for identification and diagnostic purposes

SUMMARY OF THE INVENTION The present invention relates to a composition and uses thereof for treatment of damaged tissue, comprising at least one essential amino acid in L form and at least one essential lipid; wherein the composition is administered to a mammal suffering from severe tissue damage. The invention further relates to a composition and uses thereof comprising a mixture of one or more free L-amino acids in which the molar ratio of the free L-amino acids and non chiral glycine, correspond to the molar ratio of amino components, as specified by the genetic code, in a mammalian tissue protein; and at least one essential lipid.

The invention also relates to a composition comprising a mixture of one or more free L-amino acids and at least one essential lipid; wherein the molar ratio of the free L-amino acids corresponds approximately to the molar ratio of amino components in a medicament, particularly a cyclosporin or penicillin. For example, the activity of cyclosporin or penicillin can be mimicked by administration of a therapeutic formulation having components that could be combined to create a ring, linkage, or other moiety that mimics a lactam ring. More particularly, it mimics the CO-N bond of the beta-lactam ring, which is believed essential to the therapeutic activity of penicillin and cyclosporin. Furthermore, the inventive therapeutic formulations avoid microorganism metabolites and proteins such as those having D-alanine, and D alanyl groups as are present in penicillin. It is believed that by providing the amino acid stereoisomers, native to the mammalian body— namely. L amino acids, and non-chiral glycine and L phospholipids such as phosphatidyl choline in optically pure form, regeneration of damaged tissue is enhanced.

Composition therapeutics also comprises a plurality of amino acids having a molar ratio which is characteristic of human bowel protein and further comprises a fatty acid, gamma-amino butyric acid or L-carnitine. Using FDA-pre-approved-as-safe components equivalent to the components of human tissue, composition therapeutics is immunologically concordant with genetic 'self and the immuno-inflammatory barrier and thereby avoids crossing and activating the immuno-inflammatory barrier.

The present invention also relates to immuno therapeutic compositions and uses thereof, for diseases of poor or guarded prognosis. Composition therapeutics mimics mammalian and human tissue, and immunologic 'self. As micronutrient microenvironment immunologic 'self, it is thereby bio-chemically invisible and does not activate the inflammatory cytokine chemo-attractant system. These therapeutics are immunologically privileged and therefore can cross animal and plant barriers and disease cell line. The subject therapeutic component precursors provide healing, repair and regeneration systems. This immunotherapeutics activates synthesis of protein, an essential component of anabolic characteristic of anabolic healing, associated protein polymerases of DNA and RNA, and the patient's own stem cells non-invasively. The anti-inflammatory immunotherapeutic anti- catabolic efficacy is associated with reduction in release of inflammatory cytokines and chemo-attractants. It also increases the bio-chemical antagonist to interleukin inflammatory receptors associated with anti-inflammatory anti-catabolic efficacy. This results in averting the need for organ and skin transplantation. The anti-inflammatory an ti -arthritic tissue healing, repair and regeneration efficacy can avert the need for joint replacement prostheses, along with having in-vitro and in-vivo anti-cancer efficacy. Cell and tissue ordered repair and regenerative healing are provided with the use of these 3-D stereo-chemical organizational matrices' integrative fits. Thereby a therapeutic reversal is provided for damaged tissue, and the disorder and entropy of disease. This bimolecular epigenetic and genetic activation of the patient's own stem cells in cell/tissue healing immuno-therapeutics reverses a newly discovered biomolecular component of diseases of poor or guarded prognosis.

Once tissues have been activated, understanding and even directing the mechanisms that effect such tissue normalization and healing can be facilitated by the use of polarizing light microscopy. Isotropic materials, such as gases, liquids, unstressed glasses and cubic crystals, demonstrate a homogenous composition having the same optical properties in all directions. They have only one refractive index and no restriction on the vibration direction of light passing through them. In contrast, anisotropic materials, which constitute approximately 90 percent of all solid substances, particularly if the polar surface activity is hydrophilic as our tissue which corresponds to this inventive tissue replication, having optical properties that vary with the orientation of incident light with the crystallographic axes. They can demonstrate a range of refractive indices depending both on the propagation direction of light through the substance and on the vibrational plane coordinates. More importantly, anisotropic materials act as light beam splitters, in that they divide light rays into two parts (as shown, for example, in Figure 15). The technique of polarizing microscopy exploits the interference of the split light rays, as they are re-united along the same optical path to extract information about materials, including living tissue.

Although not often utilized and often undervalued as an investigative tool, polarized light microscopy can provide the benefits of brightfield microscopy, in addition to a variety of other information, which is simply not available with any other optical microscopy technique. As well as providing information on absorption color and boundaries between materials and tissues of differing refractive indices obtainable in brightfield microscopy, vital living tissue not dependent upon stain, polarized light microscopy can distinguish between isotropic and anisotropic materials. By exploiting the optical properties of anisotropy, the subject invention utilizes the detailed information obtained about the structure and composition of materials for identification and diagnostic purposes.

BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a schematic drawing of a liver illustrating the locus of congenital biliary atresia disease being close to the location of stem cells and in approximately the area of believed therapeutic activity. Biliary atresia is evidenced by a sheet of periductular inflammation and fibrosis. Also shown on this H&E slide, is extensive periductule inflammation. This inflammatory obstruction also prevents re-anastomosis of the biliary ductules, diagrammatically illustrated here by superimposing the histopathology of biliary atresia upon the normal microscopic anatomy of the liver.

FIG. 2 is a schematic diagram showing Bio-environment of natural healing and the essential component of the anti-inflammatory process FIG. 3 illustrates the typical tetrahedron structure of L alpha amino acids and glycine molecules. In consideration of the surface phenomenon in this therapeutic regime the L amino acid and glycine intermolecular tetrahedron provides a 3D surface fit in protein synthesis in tissue and organ healing. In contrast, the benzene ring compounds, from which many medications are derived, do not share this fit (in contrast, a 3D planar gliding action is present) in protein synthesis and actually interferes with protein synthesis.

FIG. 4 illustrates the protein synthesis matrix and amino acid HLB hydrophiliciy depend protein folding basis of bioactivity for compact disc software mediated by amino acid magnet-like dipole. FIG. 5 is a schematic showing the cell biology of F.A.S.T.™ and synergistic bio- environmental components.

FIG. 6 Mitotic apparatus isolated from cleaving sea animal eggs (sea urchin) FIG. 7A is a table showing two examples of amino acid hydrophobicity scales. The varying of the structured function with the biologic composition is dependent upon the genomically templated precise protein amino acid position and structure of this polymer chain of amino acid analog to a string of pearls. Additionally, the dipole magnet-like amino acid has relative forces that determine the ultimate 3D structure of tertiary and secondary proteins. For example this 3D fit explains the enzyme and it's fit with a substrate (fig.8). This also explains the antibody product of the immune system and its antigen fit. Any change, such as extreme heat or cold, has the ability to change or denature the natural 3D biologic structural conformation and therefore the 3D biologic fit and function and hydrophilicity is disrupted. For example, the hydrophilic free amino acid lysine has a 99 -100% anticancer activity as measured in-vitro. Lysine is found to be highly hydrophilic and therefore, as we have found, highly anti-carcinogenic, as seen on the relative hydrophilicity chart of amino acid specified by the genetic code of human protoplasmic tissue protein a di-amino free amino acid. In the most excitatory dicarboxylic amino acids, glutamate and aspartate they have extremely powerful excitatory effects on neurons in every region of the central nervous system as central neural transmitters and are of potential significant value in neurologic care. Gabaglycine, beta alanine and taurine are neuro-inhibitors and omega amino acids. Glycine is the most abundant amino acid with inhibitory activity found in the ventral-quadrant gray matter of the spinal cord. Glycine is of therapeutic importance in spinal cord injuries and it must be stressed that the glycine deficiency drop is proportionate to degeneration of the ventral -quadrant of the spinal cord in neurologic care of the Christopher Reeve's syndrome of traumatic quadriplegia. The therapeutic titration of glycine to achieve normal levels as a component of this therapeutic composition as well as a titratable tracked deficiency biomarker is an opportunity for enhancing management of spinal cord injury, (a disease of poor prognosis to which our therapeutics is targeted), as a component of inventive therapeutics.

FIG. 7B is an illustration of the biologic activity of a protein enzyme which is dependent on secondary and tertiary folding associated with hydrophilicity HLB.

FIG. 8 illustrates an example of how the BPTI molecule (top) fits snuggly onto the surface of the trypsin molecule (bottom), blocking the active site of trypsin. This figure is from a computer "docking" simulation, which closely (within 0.05 mm) matches the x-ray structure of the complex.

FIG. 9 is a series of photographs showing the progression of a patient undergoing the treatment regimen of the subject invention. During the course of treatment, the candidate progressed from being a liver transplant candidate to a healthy individual no longer in need of a transplant.

FIG. 1OA and 1OB are photographs of a patient that experienced non-surgical healing and tissue regeneration after receiving treatment according to the subject invention. This patient was scheduled for a skin graft. Such treatment was averted with subject composition therapeutics Figure 1OA shows the wound after the first 4 weeks without the subject composition therapeutic treatment.

Figure 1OB shows the wound 4 to 6 weeks after using subject composition therapeutics locally and systemically.

FIG. 11 shows a screen from the PubMed website on which a search was conducted pertaining to drug addiction treatments with amino acids. As indicated, well over 3,600 articles were found, of which over 180 were examined and found lacking for any discussion regarding the synergistic effects of amino acids with the other components of the subject therapeutic composition.

FIG. 12A stained image of collagen deposition as seen under a polarizing microscope

FIG. 12B unstained image of collagen deposition as seen under a polarizing microscope.

FIG. 13 is an example of a polarizing microscope utilized to obtain the images in Figures 12A and 12B, FlG. 14 illustrates the anti-cancer effect of the combined phospholipids and hydrophilic amino acid compounds.

FIG. 15 shows a calcite crystal, an anisotrophic material, placed over printed text to demonstrate double refraction or birefringence. FIG. 16A, 16B, and 16C is a series of reflected polarized light photomicrographs of typical specimens imaged utilizing this technique. On the left (Figure 16A) is a digital image revealing surface features of a microprocessor integrated circuit. Birefringent elements employed in the fabrication of the circuit are clearly visible in the image, which displays a portion of the chip's arithmetic logic unit. The polished surface of a ceramic superconducting tape (Yttrium- 1,2, 3) is presented in Figure 16B, which shows birefringent crystalline areas with interference colors interspersed in a matrix of isotropic binder.

FlG. 17A is a photomicrograph of a dispersion of monocaprin in water, showing the spherical dispersion aggregates with internal lamellar structure. Magnification: Bar=30μm, polarized light. FIG. 17B is a photomicrograph of a commercial salad dressing made with egg-yolk lecithin. The birefringent layers around oil droplets are evidence of liquid crystalline surface films. Magnification: Bar=100μm, polarized light.

DESCRIPTION OF PREFERRED EMBODIMENTS 1. Therapeutic Formulations

The present invention involves administering to a mammal a therapeutic foπnulation comprising a mixture of at least one free L-amino acid, including at least one free essential amino acid in L stereoisomer form; and one or more essential lipids. Preferably, the L-amino acid profile simulates (1 ) the amino acid components of the proteins normally present in healthy tissue that is now diseased or is a transplanted tissue; or (2) the amino acid components of a medicament, preferably a medicament that is a polypeptide, peptide, protein, or analog of any of these.

Lamino acids are used in the invention because this stereoisomer is what the mammalian body naturally makes and uses. Preferably, the therapeutic formulations of the invention contains L amino acids in optically pure form. Optically pure, is herein defined as having at least 90% by weight of one stereoisomer and 10% by weight or less of one or more other stereoisomers. Preferably the L amino acids are at least 95% by weight of the L isomer and 5% by weight or less of the D isomer, and most preferably over 99% by weight of the L isomer and 1% or less by weight of the D isomer. Optically pure L amino acids are commercially available and also are readily obtainable by methods known to those of skill in the art, for example, by synthesis from an optically pure intermediate.

Essential amino acids are defined as the amino acids that must be supplied in the diet because the organism cannot synthesize sufficient quantities of them. Essential amino acids for adult humans are arginine, histidine. isoleucine. leucine, lysine, methionine, threonine, tryptophan, and valine. Essential amino acids for other groups of patients are known to those of skill in the art. Free amino acids as used herein mean amino acids that are not part of a peptide or a protein. Free amino acids may be in acid or salt form. Essential lipids are defined as the lipids that must be supplied in the diet because the organism cannot synthesize sufficient quantities of them. For mammals, the essential lipids include linoleic, and linolenic acids. The essential lipids are preferably obtained from flaxseed, soy, safflower or sesame oils.

Analog is defined as a chemical component with a structure similar to another but differing from it in respect to a certain component. An analog may have a similar or opposite action metabolically.

One preferred therapeutic composition comprises one or more free essential amino acids in L form, one or more essential lipids, one or more protective antioxidant lipids (such as EPA), and one or more mucopolysaccharides, such as chondroitin sulfate. Another preferred therapeutic composition comprises one or more free essential amino acids in L form, one or more essential lipids, one or more protective antioxidant lipids (such as EPA), one or more phospholipids, and one or more glycolipids. Yet a more preferred embodiment further comprises lipoproteins.

Optionally, the therapeutic formulation may further comprise one or more simple sugars (e.g., monosaccharides or disaccharides). such as glucose or fructose; one or more nonessential fats or lipids such as triglyceride fats, mono- and diglycerides, phospholipids such as phosphatidyl choline and phosphatidyl serine, glycolipids, and lipoproteins; vitamins; minerals; amino acid-like components such as taurine and carnitine; and choline. Preferably, at least one fish oil derived fatty acid lipid or fat, such as EPA (cicosopentanoic acid), and at least one short or medium chain fatty acid lipid or fat (as a source of quick energy rather than fat storage), is also present.

Optionally, at least one mucopolysaccharide such as shark cartilage, chondroitin sulfate, collagen, cartilage, hyaluronic acid and hyaluronan mucopolysaccharide is also present in the therapeutic formulation. The mucopolysaccharide is believed to stimulate the immune system and to have anti-nco-inflammatory and anti-neoangiogenesis activity.

Preferably, the therapeutic compositions comprise amino acids in ratios that correspond generally to the ratios of amino acid components in healthy tissue, embryonic cells, or a medicament.

For example, damaged skin, such as that caused by scurvy, atopic dermatosis, psoriasis, or pemphigus, can be treated by a therapeutic formulation that mimics the amino acid components of healthy skin protein. One example of such a therapeutic formulation is as follows: 3 moles L methionine, 16 moles L proline, 13 moles L tyrosine, 30 moles L asparagine, 8 moles L phenylalanine, 20 moles L cysteine, 50 moles L leucine, 38 moles L serine, 29 moles L arginine, 21 moles L threonine, 21 moles L valine, 3 moles L histidine, 9 moles glycine, 22 moles L alanine, 14 moles L isoleucine, 2 moles L tryptophan, 46 moles L glutamic acid, 12 moles L lysine, 14 moles L aspartic acid, and 32 moles of L glutamine. The molar ratios may vary about 50%, and more preferably about 10%, and still provide the inventive therapy. For example, the 2 moles of L tryptophan in the above foπnula may be considered 2 plus or minus 1 mole L tryptophan and, more preferably, 2 plus or minus 0.2 mole L tryptophan. To treat scurvy, the above formulation would be administered cither orally or topically in combination with 500 to 1000 milligram ascorbic acid daily. Scurvy is known to result in skin at the edge of wounds that has an almost complete absence of the 3 and 4 hydroxy proline of hydroxylated L proline amino acids normally present as 16 of the 404 moles in the amino acid components of skin protein. It is believed that the formulation of the invention will work by providing a complete replacement amino acid mixture to allow formation of new, complete skin protein that will accelerate the healing resulting from ascorbic acid therapy. Another example is a formulation that mimics the amino acid components of fibrinogen. The deficiency of fibrinogen called a fibrinogenemia, or hypofibrinogenemia, can result in blood clotting deficiencies (abnormal hemostasis), a coagulopathy. In addition to the common therapy of intravenously administering the sterile fraction of normal fibrinogen found in human plasma, the following inventive therapeutic formulation can be administered orally to accelerate improvement of clotting. This includes 15 moles L methionine. 41 moles L proline, 24 moles L tyrosine, 30 moles L asparagine, 28 moles L phenylalanine, 13 moles L cysteine, 51 moles L leucine, 107 moles L serine, 54 moles L arginine, 59 moles L threonine, 45 moles L valine, 19 moles L histidine, 97 moles glycine, 37 moles L alanine, 26 moles L isoleucine, 19 moles L tryptophan, 64 moles L glutamic acid, 42 moles L lysine, 50 moles L aspartic acid, and 30 moles L glutamine. The molar ratios may vary about 50%, and more preferably about 10%, and still provide the inventive therapy. By co-administration of this inventive formulation with administration of normal fibrinogen, the dependency on intravenous medication is reduced.

Without being limited by theory, it is believed that the inventive therapeutic formulations work to promote tissue repair by providing stem cells with the optimal ratios and proper stereoisomer form of amino acids that are needed to synthesize new tissue, or to allow the synthesis in-vivo of a desired medicament. Furthermore, it is believed that by supplying the body with the chemical components of the extracellular matrix, such as cartilage-containing chondroitin sulfate and collagen, tissue repair and anti-inflammatory anti-neoangiogenesis is enhanced. Also, it is believed that the two essential fatty acids, linolenic and linoleic acids, and eicosapentanoic acid (EPA) favorably enhance the body's production of anti-inflammatory prostaglandin 3, and prostaglandin 1, over the production of prostaglandin 2, which has been shown to mediate disease. Cell membrane formation and repair is believed to be enhanced synergistically by the administration simultaneously (as in one formulation) of lipids, phospholipids, lipoproteins essential fatty acids, and EPA.

Without being limited by theory, it is believed that the present invention functions by the method of altering the balance of free L amino acids such that under the law of mass action, protein synthesis is favored over proteolysis. By adding additional free amino acids, the activity of enzymes involved in protein synthesis and degradation, such as proteases, is driven in the direction of protein synthesis and therefore in the direction of tissue production rather than protein degradation. Also, it is believed that the addition of L amino acids inhibits or arrests the catabolic the protein degradation reactions of these enzymes. It is believed that the therapeutic compositions of the present invention can be used to achieve similar therapeutic effect as cyclosporins. Cyclosporins are a group of nonpolar, cyclic oligopeptides, with immunosuppressant activity. The therapeutic formulations of the invention would be advantageous over cyclosporin because it is believed that the inventive compositions would not have any of the following risks associated with cyclosporin therapy: cancer, nephrotoxicity, and hepatotoxicity. Cyclosporin effects are expected with the following composition (composition no. 1): 2 moles L valine, 4 moles L leucine, 2 moles L alanine, 1 mole glycine, and 2 moles of a methyl donor, such as methionine or betaine. The molar ratios may vary about 50%, and more preferably about 10%, and still provide the inventive therapy. For example, the 2 moles of L valine in the above formula may be considered 2 plus or minus 1 mole L valine and, more preferably, 2 plus or minus 0.2 mole L valine. Optionally, one mole of a methyl donor such as methionine or betaine is substituted with 1 mole of gamma amino butyric acid, also called 4-amino butyric acid (composition no. 2). Another preferred embodiment has the same components as composition no. 1 or no. 2 and further comprises one mole of a nine carbon ring amino acid derived from the metabolism of a microorganism such as the fungus Tolypocladium inflatum Gams, and an additional mole of a methyl donor. The molar ratios may vary about 50%, and more preferably about 10%, and still provide the inventive therapy. Preferably, the therapeutic formulation administered to mimic the effects of cyclosporin is comprised of optically pure L stereoisomers of the desired amino acids. If a formulation of optically pure L stereoisomers fails to yield the desired results in an acceptable time frame, however, it may be desirable to substitute 1 molar ratio of alanine in an optically pure D form for the L form. Such a substitution should more closely resemble the stereochemistry of the amino components naturally found in cyclosporin.

Although sulfasalazine (also known as azulfidine) is not a protein or peptide, it is believed that the therapeutic effects of sulfasalazine can be mimicked by a therapeutic formulation of the present invention in which the presence of four nitrogen linkages, such as are present in sulfasalazine, may be simulated by an electron affinity of three or more high energy amphoteric, zwitterionic essential and non-essential L amino acids, preferably amino acids having aromatic side chains such as phenylalanine, tyrosine, and tryptophan. Alternately, if the desired therapeutic goals are not achieved in an acceptable time, one mole of 5 aminosalicylate may be substituted for one of the three moles of high energy amino acids specified above. This internal milieu equilibrium might also be aided by bonded van der Waals forces, as is believed to function in the inventive therapeutic formulation corresponding to cyclosporin.

It is also believed that the therapeutic effects of protease inhibitors can be mimicked by a therapeutic formulation according to the present invention.

It is additionally believed that the therapeutic effects of antibiotics such as penicillin and cephalosporin can be mimicked by a therapeutic formulation of the present invention comprising amino acids that correspond to the amino components in a lactam ring, and particularly that correspond to the components in the CO--N bond of the beta-lactam ring. For example, a formulation comprising L alanine may be used. Also, a formulation of L glutamic acid may be used, as glutamic acid may lose one mole of water during digestion and metabolism to form a lactam of glutamic acid.

The therapeutic formulations of the present invention work with negligible risk of side effects or complications from therapy and are very safe.

2. Formulations and Dosaging

The flavoring of the inventive therapy is a concern when not used in infancy. The free amino acids have a very disagreeable flavor that must be masked to obtain good patient compliance with the therapy. Oral formulations having elemental amino acids that are intended for patients over the age of one year preferably include one or more flavorants, synthetic or natural, such as grape, grapefruit, especially pink grapefruit, vanilla, cream, apple, chocolate (especially hypoallergenic). Milk permeates (especially hypoallergenic milk permeates) may be used, but preferably the microorganism debris is minimal. Most preferably no microorganism debris is detectable in milk permeates used as flavorants. Optimal efficacy of the inventive formulations and therapy occurs with concurrent avoidance of foods having exogenous catabolic debris. Foods avoided include, foods containing microorganism flora, debris and protein products, and foods that have been pasteurized, such as pasteurized dairy products, with the exception of lactic acid pro-biotic bacteria. Foods to avoid include those of such potentially significant microorganism content that pasteurization is required, and foods prepared by enzymatic activity of microorganisms, such as cheeses and wines produced by fermentation. The avoidance of foods with exogenous microorganism catabolic debris is believed to minimize or reduce the competition between catabolic products and the nutrients of the present invention and thereby drive protease activity that favors formation of healthy tissue and organ repair. The microorganism catabolic products, including lipopolysaccharide (LPS), and especially microorganism protein LPS, are expected to oppose the desired protein synthesis. Additionally, toxic metabolites of Aspergillus such as are found in peanuts are preferably avoided. In particular, patients suffering with Crohn's disease (regional ileitis) and congenital biliary atresia should avoid milk products. Preferably, the therapeutic formulation is free of hydrocolloids, preferably the hydrocolloids that might cause gastrointestinal irritation and inflammation.

This invention is applicable to treatment of all age groups, including prenatal, pediatric, adult and elderly. The invention is envisioned for use in treating any mammal. For example, the inventive therapy may be used to prevent or slow the cyclic epidemic spread of Johne's Disease (ileitis) in dairy cattle and other similar animals.

Proper dosages can be ascertained by one of skill in the art, using the teachings of this disclosure and readily available literature. Free amino acids may be derived from natural sources or synthetically produced. Suppliers include Ajinomoto USA of Torrance, Calif, and Tanabe USA Inc. of San Diego, Calif. One preferred source of amino acids is Neocate. RTM. elemental diet, sold by SHS of Liverpool, UK, which contains inter alia essential and nonessential amino acids, dried glucose syrup, fat, minerals, trace elements and vitamins.

The preferred amino acid dosages of the inventive therapeutic formulations are below the dosages recommended for an elemental diet for infants or others having gastrointestinal problems. Preferably, total daily free amino acid dosage is less than 20 grams, more preferably less than 15 grams, and still more preferably less than 10 grams. A preferred regime comprises administering 1-2 grams free amino acids three to four times daily, for a total dosage of three to eight grams daily. The higher dosages needed for a complete dietary supplement are commonly rejected by all but infants under age one because of the unpleasant taste and smell of free amino acids. By using much lower dosages, the present invention promotes patient compliance because small dosages may be administered in capsules or with flavorings such that taste problems are minimal.

Dosaging is dependent upon the age, body weight, and medical condition of the patient. Because of the negligible risks associated with the inventive therapy, higher dosages may be considered in more critical cases. The preferred effective total daily dosages of free amino acids is 0.5 to 20 grams, and more preferably 1 to 10 grams per day for an adult. ½ that dose is appropriate for children age 6 tol2, and ½ that dose for children under age 6. Preferably the daily dosage is divided into 3 to 6 administrations per day. Preferably, the amino acids are provided in total daily dosages that are within the following weight ranges:

L alanine preferred dosage, 0.05-12.5 grams, niore preferred dosage, 5-9 grams. L arginine preferred dosage, 0.05-12.5 grams, more preferred dosage, 1-9 grams. L asparagine preferred dosage, 0.05-12.5 grams, more preferred dosage, 0.5-9 grams. L aspartic acid preferred dosage, 0.05-6 grams, more preferred dosage, 0.5-6 grams. L cysteine preferred dosage, 0.1-1 gram, more preferred dosage, 0.5-1 grams. L cystine preferred dosage, 0.5-12.5 grams, more preferred dosage, 0.5-9 grams. L glutamine preferred dosage, 0.5-12.5 grams, more preferred dosage, 0.5-9 grams. L glutamic acid preferred dosage, 0.5-<6 grams, more preferred dosage, 0.5-6 grams.

Glycine preferred dosage, 0.5-12.5 grams, more preferred dosage, 0.5-9 grams.

L histidine preferred dosage, 0.5-12.5 grams, more preferred dosage, 0.5-9 grams.

L isoleucine preferred dosage, 0.5-12.5 grams, more preferred dosage, 1 -9 grams. L leucine preferred dosage, 0.5-12.5 grams, more preferred dosage, 0.5-5 grams.

L lysine preferred dosage, 0.5-12.5 grams, more preferred dosage, 0.5-9 grams.

L methionine preferred dosage, 0.5-12.5 grains, more preferred dosage, 0.0.5-9 grams.

L phenylalanine preferred dosage, 0.5-12.5 grams, more preferred dosage, 0.5-9 grams.

L proline preferred dosage, 0.5-12.5 grams, more preferred dosage, 1-9 grams. L serine preferred dosage, 0.5->6 grams, more preferred dosage, 0.5-6 grams.

L threonine preferred dosage, 5-12.5 grams, more preferred dosage, 0.5-9 grams.

L tryptophan preferred dosage, 0.5->6 grams, more preferred dosage, 0.5-6 grams.

L tyrosine preferred dosage, 0.5-12.5 grams, more preferred dosage, 0.5-9 grams.

L valine preferred dosage, 0.5-5 grams, more preferred dosage, 0.5-9 grams. L taurine preferred dosage. 0.5-12.5 grams, more preferred dosage, 0.5-9 grams.

L carnitine preferred dosage, 0.5-12.5 grams, more preferred dosage, 0.5-9 grams. The relative ratios of amino acids are derived as disclosed earlier from the ratios present in healthy tissue or medicament. These preferred molar ratios are then used to make a formulation for maximal dosage in 390 mg to 500 mg capsules, administered as about 5 capsules 3 to 4 times daily preferably. The total weight of an individual amino acid preferably should fall within the preferred weight ranges provided above.

The amino acids administered orally are readily available for absorption in the GI tract with minimal, if any degradation or processing required in the GI tract. This conserves the energy required by the GI tract and the spare energy can be used to repair diseased tissue or damaged organs.

This non-invasive medical therapy may be utilized with patients waiting for an organ transplant, or if possible, at an earlier stage in the organ disease. For example, the therapy may be administered prenatally by the mother ingesting the therapeutic formulations, or by direct administration of the formulation to the fetus. Duration of the inventive therapy is from a few weeks to several months. Longer duration of therapy may be considered because of the negligible risks associated with the inventive therapy. The compositions of the present invention may be formulated for oral, topical or parenteral use, especially oral. The topical formulations of the present invention may be presented as, for instance, ointments, creams or lotions, eye ointments and eye or ear drops, impregnated dressings and aerosols, and may contain appropriate conventional additives such as preservatives, solvents to assist drag penetration and emollients in ointments and creams. The formulations may also contain compatible conventional carriers, such as cream or ointment bases and ethanol or oleyl alcohol for lotions. Such carriers may be present as from about 1% up to about 98% of the formulation. More usually they will form up to about 80% of the formulation. Oral liquid preparations are typically in the form of a dry powder for reconstitution with water or other suitable vehicle before use. For parenteral administration, fluid unit dosage forms are prepared utilizing the therapeutic formulations of the invention and a sterile vehicle, water being preferred. It is also possible to prepare an oral mucosal delivery system such as that described in U.S. patent application Ser. No. 09/080,990, entitled "Methods and Compositions for Oral Delivery of Vitamins, Minerals, and Medications", which is incorporated in its entirety herein by reference.

In special indications, particular precautions are necessary. For example, a patient having a coma or near coma with high ammonia levels, such as a patient suffering a complication of alcoholic cirrhosis, several L amino acids, such as L glutamate (also called L glutamic acid), and L aspartic acid, are desirable because they are believed to aid in ammonia removal. L glutamine is preferably avoided with cirrhosis of the liver, kidney disease, Reye's syndrome, or any other disease with increased ammonia blood levels. L cysteine, for a patient having a chronic illness, may be required at a level of 1 gram, 3 times daily for 1 month. L arginine should be avoided during pregnancy and breast feeding. In patients with schizophrenia, L arginine is preferably administered at dosages of less than 30 milligram per day.

L valine, L isoleucine and L leucine each have branched aliphatic side chains. These amino acids are very helpful in diseases resulting from aging, as well as for trauma and infection. L tyrosine, L tryptophane, L phenylalanine and L histidine are advantageous for elderly patients with neurologic problems and depression. L methionine and L taurine are preferably used in hypersensitivity and autoimmune diseases.

Additionally, useful therapeutic applications for specific amino acids are provided in Tables IA, IB and 1C. This additional information may be useful in identifying specific cell or tissue proteins whose amino acid components can be mimicked in a therapeutic formulation of the invention. For example, tissues can be analyzed to locate high concentrations of specific amino acids known to favorably treat a specific ailment. From these tissues, specific proteins can be identified that are related to the ailment and the amino components of these proteins can be administered in one of the therapeutic formulations of the invention.

To protect unstable oils, storage in a frozen or refrigerated final product and/or a dark glass container is desirable to prevent lipid oxidation by light.

Linolenic acid, an Omega-3 seed oil most abundant in flaxseed oil, is preferably administered at about 0.5 to 35 grams daily, and more preferably at about 3 to 10 grams daily. The following other lipids preferably are included in the therapeutic formulations of the invention at a preferred dose of 0.25 to 35 grams per day, and more preferably 0.5 to 2.0 grams per day: phospholipids and their essential fatty acids such as compound lipids, glycolipids, mono- and diglycerides, lipoproteins, including, but not limited to, cerebrocides and cephalin, 1 μL lipoproteins such as, but not limited to, lipovitellin, and phosphoprotcins. Vitellin is particularly preferred for a fetus at a preferred dosage of 0.5 to 2 grams.

Where shark cartilage is used, an adult dosage is in the range of a dosage of about 740 mg to about 1480 mg administered once to three times daily and preferably 2220 mg administered once daily. For major flare-ups of autoimmune diseases or bronchitis, dosages of up to about 2240 mg three times daily are recommended. Shark cartilage is preferably administered in powder in a capsule and contains cartilage with 12% chondroitin sulfate and collagen. Shark cartilage is sold under the name of Cartilade (Ontario, Canada, formerly BioTherapies, Inc., Fairfield NJ.) When hyaluronic acid and hyaluronan mucopolysaccharides are used, the source may be human umbilical cord tissue. The shark cartilage is immunologically preferred. This species is uniquely not affected by cancer and its skeletal structure is entirely cartilage.

Autologous cartilage and chondrocytes are preferred for patients with arthritis. Preferred amino acid formulations for arthritic patients include the L amino acids combining with the body's glucose to form glucosamine, which is believed to be incorporated into the body's mucopolysaccharides. Such patients also benefit from hyaluronic acid, chondroitin sulfate, shark cartilage and nutrient substrate cartilage, available from many animals including cow, pig and chicken.

The preferred dosage of glucosamine is about 0.5 grams to about 1 gram, 3 times daily. The preferred dosage of chondroitin sulfate is about 250 to about 500 milligrams. 3 to 4 times daily. More preferred is 390 milligrams to 500 milligrams chondroitin sulfate administered three to four times daily. Preferably, chondroitin sulfate is administered in capsule form to minimize any unpleasant taste sensations and thereby encourage patient compliance. When EPA (eicosopentanoic acid) is used, the dosages may be about 0.36 to about 4.5 g daily, preferably about 0.36 grams to about 0.72 grams daily to three times daily. EPA is readily available commercially in soft gel capsules having 0.36 g EPA and 0.24 g DHA docosahexanoic acid in a 2 gram total fish oil capsule.

Preferably, the medium chain fatty acids used in the therapeutic formulations are triglycerides or other naturally occurring fatty acids found in vegetable oils, such as coconut, and soybean oils. Medium and short chain fatty acids are desirable because they are readily metabolized to energy, required for acute illness, rather than stored as fat and do not require much processing by liver. Short chain fatty acids, such as but not limited to C. sub.4 butyric acid, are also useful in the invention, particularly those present or isolated from hypoallergenic butter.

Such short chain fatty acids have local anti-inflammatory action to help treat ileitis or skin burns, preferably in combination with 200 to 400 IU vitamin E oil.

Sugars useful in the present invention, such as glucose, corn syrup solids, and fructose, are preferably administered at the dosages recommended by dietary organizations, and are known to those of skill in the art.

Preferably vitamins and minerals are administered with the therapeutic formulations of the invention. The preferred amounts of these components are provided in Table 2a, 2b, and 2c.

3. Uses and Therapeutic Indications of the Invention and Pharmacological Mechanisms (A.)Healing of Cell and Tissue

Use in reversing diseases of poor or guarded prognosis with the pharmacologic mechanisms as: (a.) an anti-inflammatory immuno-therapeutics mimicking human tissue and immunologic 'self therapeutically providing precursor micronutrient microenvironment also of immunologic 'self with (b.) associated activation of the patient's own stem cells non- invasively activating synthesis through amino acids specified by the genetic code in stimulating protein synthesis the polymerases of, DNA and RNA in stimulating the nuclear synthesis of DNA and RNA. There appears to be a self perpetuating cycle of making more DNA and RNA to in turn, synthesize protein through the amino acids and associated synergistic components of subject composition of matter. This seems to be analog to the biochemical model of the self polymerization of the nylon polymer once initiated.

(B.) Providing a Genomic repair system

This homeostatic mechanism counters randomness, entropy, breakdown, and damage of normal tissue is perpetuated by the foregoing amino acid components of the organizational matrices of the cell, cell membranes, and tissue.

This biologic model and potential entree point of this self perpetuating DNA, RNA template pattern using monomelic AMINO ACID as monomeric raw material, stimulates protein polymerization and synthesis. This occurs through subject composition therapeutics AMINO ACID bolus, which is triggered by the law of mass action and components synergy such as, but not limited, to zinc, and B vitamins. It is believed to be analog to molecular embryologic studies by Gurdon, modifying the genomic code and pattern in the sea life egg. Gurdon has shown that the injection of a pure gene (chick egg albumin gene) into the nucleus (germinal vesicles) of sea life egg (Xenopus oocytes) was followed by intense and long lasting (several days) transcription of this gene. The resulting egg albumin mRNA moved into the egg cytoplasm where it was translated into chick egg albumin.

The genetic 'self perpetuating pathway includes, and is dependant upon, the L amino acids and glycine, specified by the molar ratio genetic code of the targeted protein. DNA and RNA protein synthesis arc possible through the foregoing amino acids programmed as L amino acids and glycine specified by the molar ratio genetic code of therapeutically targeted protein. These amino acids, along with the synergistic organizational matrices of components of subject composition, are believed to therapeutically provide an L amino acid and glycine entree point to normalize the genetic code.

The therapeutic subject composition is believed to provide this self perpetuating genetic cycle and consists of the following organizational matrices: the cell membrane organizational system led by the self vesiculating, bio-robotic, bilamellar micelle L phospholipid. This liquid crystal bilamellar chemical micelle provides 20% of the cell membrane. The organizational component initiates the colloidal domain emulsion, and is associated with the L amino acids and glycine monomers. These monomeric amino acids of subject composition are specified by the molar ratio of the genetic code of therapeutically targeted protein. These amino acid monomers constitute the precursor source of the polymerized 80% of the cell membrane, as polymerized protein that have many functions including receptor sites and selective pumps.

The 3-D stereo chemical L amino acid and glycine organizational matrix, with the L phospholipids are unique to mammalian and human tissue (and differ in the case of micro organisms in that they normally contain D-amino acids that include D-alanine and D- glutamic acid). These L stereoisomers seem to provide the natural relationship with D- polysaccharides, composed of the D-monomers of D-hexose, as in the extracellular matrix compartment and D-pentose as in nuclear compartment DNA and RNA. The biochemical cell model has been used to view the function of these polymerized D-monosaccharide glycosylated in the Golgi apparatus of the cytoplasm. This functionality as tracking tags, guides the extracellular matrix (ECM). This thereby provides a soft skeleton scaffold to maintain the cells in this ECM. Otherwise, we would just be a clump of cells which has been demonstrated by the first cleavage of the stem cells in the experimental animal. If this ECM such as collagen, laminin, fibronectin is filtered away, the cells fall apart by selective filtration) only to be re-associated when the extra cellular matrix is again reproduced.

Thereby, this ECM organizational matrix of this therapeutic subject composition of matter serves a similar function in treating damaged tissue. (See Figures 2 and 3)

Another aspect of the invention provides an anabolic medicament for treating a damaged tissue. This composition of matter is also representative of organizational cellular and stem cell matrices of 1.) cell membrane receptor and activation of polar surface active lipids such as phospholipids; 2.) DNA, RNA templated protein synthesis and a protein enzyme polymerase for DNA RNA synthesis; 3.) Extracellular matrix cellular scaffold is selected from the group consisting of a glycosaminoglycan, a collagen, cartilage, chondroitin sulfate, heparan sulfate, dermatan sulfate, deratin sulfate, hyaluronic acid, a glycoprotein, and a proteoglycan; 4.) anabolic anti catabolic synergistic organizational matrices of additional activating synergizing vitamins, minerals and antioxidants. All these matrices are concurrently precursor micro- nutrient microenvironment of immunologic 'self and again does not cross the immune- inflammatory barriers and as chemically invisible does not only produce but also significantly reduce the destructive inflammatory cytokines as well as producing inflammatory receptor antagonist cytokines and is therefore anti-catabolic as well as anti inflammatory pharmacodynamic mechanisms. AU these therapeutic organizational matrix components utilize the most common non covalent biologic bonding system of human and other mammalian tissues readily available for homeostatic metabolic interchange. Yet another aspect of the invention provides an anabolic medicament for treating a damaged tissue. The medicament comprises, the organizational cell membrane matrix, essential for cell and tissue life and biologic function, which consists of at least one naturally occurring polar surface active lipid, wherein said polar surface active lipid is selected from the group consisting of a phospholipid, a glycolipid and a lipoprotein; phospholipids such as, phosphatidyl choline that bio-robotically self vesiculates to provide the spherical, bubble like shape of the cell, defined by the organizational cell membrane in the optical levorotary L form. No more than 10% of the phospholipids being in the D- form, 20% phospholipid, the 80% L amino acid glycine contained in cell membrane protein that functions as a selective protein pump, regulating the concentration of minerals (such as sodium, potassium and calcium) in and out of the cell; 38% of which is phosphatidyl choline (PC) (in the case of microorganisms, 0% PC is present),the L-amino acid and glycine of the targeted protein specified by the genetic code, selected from the group consisting of a glycosaminoglycan, a collagen, cartilage, chondroitin sulfate, heparan sulfate, dermatan sulfate, deratin sulfate, hyaluronic acid, a glycoprotein, and a proteoglycan.

In conjunction with the organizational matrices of subject composition that we have found also to correspond with the organizational matrices of the stem cell and the formation of the primary amino acid polymer; the secondary folding is dependent upon the comparative hydrophilic/lipophilic forces, characteristic of each L-amino acid and glycine. This is ultimately characterized by the final 3-D folded arrangement of the tertiary protein, which provides its biologic function. All this is bio-molecularly inter-dependent with the organizational matrices of therapeutic subject composition that also corresponds with the organizational matrices of the developing embryonic stem cell and the corresponding healing stem cell itself. The stem cell and the synergistic organizational matrices of therapeutic subject composition as seen in the healing, anti-inflammatory effect of the stem cell, and its role in molecular embryology, genesis of embryonic stem cell in molecular embryology: These molecular biochemical steps of embryogenesis are identical to the molecular biochemical subject composition of matter, and therefore the same activating biochemical molecules as the stem cell:

1. Cell membrane organizational matrix (see Peil supra)) activation in cell membrane fusion of the sperm and egg, amphimixy, in fertilization by the sperm's release of phospholipase to remove one fatty acid 'arm', providing an increase in hydrophilicity, resulting in fusion of the membranes of the sperm and the egg.

2. Within a few minutes of sperm fertilization, the organizational matrix (see Peil supra)) L-amino acid glycine, specified by the genetic code of protein synthesis is initiated. Experimental tracking using radio-actively tagged free amino acids, are now being incorporated into protein synthesis in the now activated metabolic, 'sleeping' egg.

3. Upon cleavage of the embryonic stem cell, the production of the organizational extra-cellular matrix (see Peil supra)) scaffold is activated. When filtered away, the cells fall apart, only to be reformed so that cell adherence organization can continue. Each step of embryogenesis can be arrested by similar experimental removal from arresting the life of the cell itself, to arresting gastrulation and neurulation. (See Figure 5)

The organizational cell membrane matrix, essential for cell and tissue life and biologic function, consists of at least one naturally occurring polar surface active lipid. The polar surface active lipid is selected from the group consisting of a phospholipid, a glycolipid and a lipoprotein. Phospholipids such as, phosphatidyl choline, bio-robotically self vesiculates to provide the spherical, bubble like shape of the cell, defined by the organizational cell membrane in the optical levorotary L form. No more than 10% of the phospholipids being in the D- form 20% phospholipid, the 80% protein also functions as a selective protein pump. Additionally, it regulates the concentration of minerals (such as sodium, potassium and calcium) in and out of the cell; 38% of which is phosphatidyl choline (PC) (in the case of microorganisms, 0% PC is present advantageously) the L-amino acid and glycine of the targeted protein specified by the genetic code. A plurality of amino acids having an alpha carbon, the amino acids being present at a molar ratio as specified by the genetic code. This is characteristic of the targeted protein in such as human breast milk protein, bowel protein, such as skin proteins. Wherein no more than 10% of the amino acids are in D-foπn, a plurality of amino acids having an alpha carbon, the amino acids.

The cell membrane organizational matrix and its hydrophilic forces so provide function in conjunction with the extra-cellular organizational matrix (ECM). a glycosaminoglycan, a collagen, cartilage, chondroitin sulfate, keratin sulfate, heparan sulfate, (a highly anionically charged, highly sulfated, highly hydrophilic, ECM component) glucosamine sulfate, a glycoprotein, and a proteoglycan; These hydrophilic forces are found to simulate the most hydrophilic surfactants such as sodium lauryl sulfate which it simulates the ECM components, such as glucosamine sulfate, chondroitin sulfate, heparan sulfate, and (most important component of the basement membrane of the glomerulus of the kidneys filtration system. All these ECM components are not only highly hydrophilic, but also, anionically charged. All the ECM protein components are glycoproteins which are glycosylated and import additional hydrophilic forces in the GoI gi apparatus of all the cells' cytoplasm.

The HLB Mechanisms of Protein Folding of Amino Acids in the Polypeptide Chains of

Proteins

These amino acids function in protein folding as dipolar magnets with forces mediated by the HLB balance, ratios and particle charges where the majority (80%) of essential amino acids are more lipophilic and the branched chain amino acids being the most lipophilic. Wherein, the majority (80%) of the non-essential amino acids are hydrophilic.

These in turn fold in accordance with their relative HLB value so that the essential amino acids can be found in the center. The final folded protein is a lipophilic protein core analogous to a fetus being protected by the surrounding hydrophilic surfactant amino acids. These amino acid components Ic are all liquid crystals with amphiphilic polar surface activity of 6,974.796.

Component 1C functions like component Ib and the glycoprotein ECM of component I a.

Additionally, parts of the ECM have a lipid foot anchor to the cell membrane. These glypicans are being similarly composed of amino acids with a hydrophilic signaling the destination directional carbohydrate moiety for each glycoprotein.

The relatively highly hydrophilic effect so important in wound healing are also effected by the components of 6,974,796 and subsequent patent filings appear to explain the anti-cancer activity of the components that are highly hydrophilic. (See Figure 4)

(C.) Anti-inflammatory effects, and anti-inflammatory effect in conjunction with cell and tissue healing

The pharmacodynamics and subject therapeutic compositiυn-υf-matter result in cell/tissue immunologic healing through the production, in-vivo, of DNA, RNA and protoplasmic tissue protein. This therapeutics provides the pharmacodynamics of cell and tissue healing, repair and regeneration with significant anti-inflammatory activity. This subject composition therapeutics also includes a reduction in chemical mediator, chemo- attractant inflammatory cytokines, uniquely associated with the stimulus of protein synthesis in healing. Tissue healing integrity, strength and resilience result, being first initiated by normalization of the cell membrane receptor system. This includes 247 case reports, clinical, in-vivo, oral, and intravenous and local delivery system application inclusive of 70 in-vitro studies which further includes in-vivo, 27 equine veterinarian therapeutic responses (serving as pre-clinical cell biology study models as well as specific care for equine veterinarian diseases).

Additionally, the Omega-3 fish oils reside in the organizational cell membrane matrix of subject composition. In this capacity, these FDA pre-approved-as-safe, components reduce inflammatory prostaglandins without any known undesirable effects. The mechanism by which this is done is replacement of arachadonic acid at membrane storage sites in phospholipids in dietary fish oil. It serves as a poor substrate for convergence to active metabolites of a cyclo-oxynigase formation of prostaglandin (inhibited by NSAID), particularly the lipo-oxyginase series (not inhibited by NSAID). Therefore, we have also shown here an advantage of the Omega 3-fatty acid fish oils adding to the anti-inflammatory effect of subject composition therapeutics, over and above NSAID, such as aspirin.

This is in contrast to available anti-inflammatory drugs, such as the non steroidal antiinflammatory drugs (NSAID and steroidal drugs) that interfere with healing and protein synthesis, even though they have an anti-inflammatory effect. As a result of this intermolecular sliding, in contrast to the L-amino acid glycine specified by the genetic code 3-D fit, NSAID compounds interfere with protein synthesis and healing. This concurs with 20 recent studies: recommending avoidance of NSAID wound healing; included in their entirety by reference.

The present invention also relates to an immuno-therapeutics composition and use thereof for disease of poor or guarded prognosis that mimic mammalian and human tissue, immunologic 'self, healing, and repair and regeneration systems. This immuno-therapeutics activates synthesis of protein, DNA, RNA, and the patient's own stem cells. The foregoing synthesis is activated non-invasively, with anti-inflammatory efficacy, averting the need for organ and skin transplantation. The anti-inflammatory anti-arthritic tissue healing, repair and regeneration efficacy averts the need for joint replacement prostheses, along with in-vitro, and in-vivo anti-cancer efficacy.

(D.) Pain Management and Pharmacologic Mechanisms with Use of Subject Composition: These therapeutics offer a highly unique and desirable approach in pain control management by providing definitive, as well as symptomatic, pain relief and pain prevention. The unique immunotherapeutic agent of Immunopath Profile Inc. (IPI) is an FDA approved biomaterial therapeutics. It has been observed to treat pain of many known etiologies. Successes have also been seen in pain accompanying various forms of malignancy. This modality of treatment embraces an individual's own natural cellular make-up. This has been cited as regenerative medicine which includes the revitalization of tissue and its normal neural response to IPFs immunotherapeutic approach to the treatment of pain. This therapeutics is readily adaptable with other modes of treatment. Regenerative medicine with IPFs therapeutics provides resolution of diseases of poor prognosis that now have the additional benefit of successful pain relief.

In summary, the subject invention presents a more definitive regenerative medicine immunotherapeutics for disease resolution in, such as but not limited to, this progressively severe inflammatory disease, IBD and may include ulcerative colitis, mucus colitis, irritable bowel syndrome and further include celiac disease because of mechanisms herein of improving abnormal intestinal permeability. About 25% of the cases in Crohn's and IBD have an onset in childhood.

IBD is a chronic persistent inflammatory disease of poor or guarded prognosis and a pathogenic continuum which can progress to cancer, caused by inflammatory chemicals released that perpetuate inflammation, cytokines, chemokines, cyclo-oxygenase and lipoxygenase prostaglandins and other inflammatory chemicals provide a distinct network of intercellular signaling which promote development of cancer. "Chronic inflammation plays a multifaceted role in carcinogenesis".... "metastasis and invasion", "tumor angiogenesis" The subject invention provides sustained anti-inflammatory protein synthesis stimulating healing therapy has been shown to block production of inflammatory cytokines and increase production of anti-inflammatory cytokines (Meister 2000) and its extension to cancer.

As exemplified by the 30X predisposition to bowel cancer in contrast to the general public with prolonged inflammatory disease as seen in ulcerative colitis and the 6x predisposition to bowel cancer in contrast to the general public of Crohn's disease. The same unique anti-inflammatory efficacy to arrest persistent aggressive inflammatory action of IBD by subject composition immunotherapeutics is used here for its preventive anti-cancer therapeutic efficacy and safety which has been optimized and maximized in this therapeutics. Using therapeutic subject composition includes the management of diseases and damaged tissue with particular regard to, but not limited to, diseases of poor and guarded prognosis, inflammatory changes, accompany failure to heal. Pain management (pain control) efficacy has been established based on the clinical experience of 177 patients included in this therapeutics. Therefore this subject composition therapeutics is included as a pain management medication. The inflammatory changes are associated with pain, swelling, redness and heat. Inflammation is present in all of the major diseases such as trauma, inflammatory diseases, and neoplastic diseases. The pharmacologic mechanisms for pain relief include reduction of inflammation by as much as 80%, and providing an increase in inflammatory antagonistic factors by as much as 80%. These inflammatory antagonistic factors include such as ILl receptor antagonist of inflammatory cytokine and chemo- attractant chemicals, otherwise released by the immune-inflammatory system. Additionally, since subject composition functions as immunologic 'self, it is therefore bio-chemically invisible and does not cross the immune-inflammatory system. It therefore does not activate cytokine release, as many other medications do as part of the pharmacologic mechanism of their undesirable effects. This is probably a major reason why the components of subject composition that have additionally been screened immunologically, are in the category of FDA pre-approved-as-safe components. This includes their final composition of matter which has mimicked human tissue and immunologic 'self. With use of subject composition pain control in these diseases or poor or guarded prognosis, pain management and pain control has been accomplished.

Additionally, the Omega-3 fish oils reside in the organizational cell membrane matrix of subject composition. In this capacity, these FDA pre-approved-as-safe, components reduce inflammatory prostaglandins without any known undesirable effects. The mechanism by which this is done is replacement of arachadonic acid at membrane storage sites in phospholipids in dietary fish oil. It serves as a poor substrate for convergence to active metabolites of a cyclo-oxynigase formation of prostaglandin (inhibited by NSAID), particularly the lipo-oxygenase series (not inhibited by NSAID).

Therefore, we have also shown an advantage of the Omega 3 -fatty acid fish oils adding to the anti-inflammatory effect of subject composition therapeutics, over and above NSAID, such as aspirin. The importance of the production of the inflammatory chemicals cytokine, chemokines and prostaglandins in chronic persistent inflammation and its continuum and extension to cancer is shown by the therapeutic efficacy of subject composition. Anti-inflammatory drugs such as the NSAID exemplified by aspirin are demonstrated by the 25-50% successful anti-cancer activity of aspirin. However, aspirin unfortunately inhibits protein synthesis, healing and stem cell healing activity. Therefore, this significantly lessons the value of these compounds and illustrates the advantage of the regenerative medicine taught by the subject and related applications. This advance provides anti-inflammation and stimulation of protein synthesis and healing.

(Case 1.) Pain management of a male patient, age 82, presenting with prodromal symptoms of herpes with severe unilateral left ocular edema and conjunctivitis with vesicles on left side of forehead. A very common associated clinical finding of herpes zoster of the forehead up to the hairline, This was preceded by pain upon combing hair, also on the left side of head, one day prior to dermatologic involvement. Transdermal cream of subject composition was applied to left scalp and left forehead was associated with clearance pain with particularly noteworthy absence of residual pain. Usually this is associated with poor prognosis in regard to the persistence of pain. Also, corneal damage was not noted in this patient with use of subject composition transdermally, (as presented here in case reports of reversal of arthritis and tendo-synovitis in 27 horses of equine species). The treating ophthalmologist was happily surprised with this outcome. He did not feel the acyclovir topical 5% applied 3 times daily played a role. Nor did he feel that the acyclovir oral therapy 200 ing 3 to 4 times daily played definitive role seen with subject composition in completely averting the very common residual complications of herpes zoster and normalizing neuronal impulse flow along with normalizing tissue structure and function, (one year follow-up)

Case 2.) report of a male patient, early 80s, normalizing post abdominal surgery of right upper quadrant, residual incisional anesthesia associated with residual complication of cholecystectomy of gangrenous cholecystitis, a complication of cholelithiasis, (further complicated by e-coli septicemia). Numbness of the skin of the right upper quadrant has persisted since surgery several years prior. Clearance of numbness resulted with the use of the transdeπnal cream applied 2 to 3 times daily for one week. Again, this normalization of tissue and normalization of neuronal flow has remained normal since transdermal cream application, (about one year). Case 3.) Pain management, of a female patient, age 75, who was awakened with acute cervical pain and tenderness. Treated with transdermal cream she was able to return to sleep, and awoke in the morning with no pain. The patient has remained symptom free, to date, for more than one year. Past history of a similar onset of acute cervical arthritis which took several months of orthopedic care for symptoms to resolve.

Please note that the local use of a component of human tissue such as vitamin E (alpha tocopherol) by expressing it from a vitamin E capsule (400 IU) andapplying the oily contents onto the wound or area of pain has significantly augmented pain management and alleviated local pain. This is also a component of subject composition. Significant relief has been repeatedly noted. This pain management component has been used in many patients of varied ages and multiplicity of causes with continued good success, alone or as a component of subject composition as in the transdermal cream.

(E.) Stem cell activation in the treatment of tissue damaged such as by trauma or disease and the stimulation of healing through activation of the patient's own stem cells using:

This therapeutic subject composition breakthrough activates, non-invasively, the patient's own stem cells, allowing the cells to thrive in-vivo or in-vitro without any apparent risks. This includes 247 case reports of, clinical diseases of poor or guarded prognosis in- vivo, in-vitro, oral, intravenous and local transdermal delivery system application, including 25 equine veterinarian therapeutic response and in-vitro studies. This represents the pharmacodynamic end-point of cell biology, and biochemical activation of the patient's own stem cells in regeneration and repair of the patient's diseased and damaged tissue.

The pharmacodynamics and subject therapeutic composition-of-matter protected by issued patent claims result in cell/tissue immunologic healing through the production, in- vivo, of DNA, RNA and protoplasmic tissue protein. This therapeutics provides the pharmacodynamics of cell and tissue healing, repair and regeneration. Subject composition therapeutics provides significant anti-inflammatory activity and reduction in chemical mediator chemo-attractant inflammatory cytokines, uniquely associated with the stimulus of protein synthesis in healing. Tissue healing integrity, strength and resilience result, are being first initiated by normalization of the cell membrane receptor system.

This occurs by mimicking human or animal tissue respectively; using biochemical equivalent components, FDA pre-approved-as-safe, immunologically further screened so as not to cross the immimo-inflammatory surveillance barrier. Also, this is the case of mimicking the embryonic stem cells from which all cell and tissue originates. The pharmacologic impact of therapeutics subject composition cell free microenvironment, can best be seen with this diagram of the progressive development of the embryonic stem cell. (Non-invasively applied in anabolic tissue healing stimulation of protein synthesis and inhibiting the chemical mediators of inflammation and associated anti-inflammatory activity.)

This subject composition therapeutics is not only based on mimicking human tissue using biochemical equivalents of human tissue that are FDA pre-approved-as-safe. We simultaneously mimicked the human tissue's healing, repair, and regeneration using the same components representing biochemical equivalents of human tissue from the healing repair and regeneration system. This has been found to be equivalent to mimicking the embryogenesis and the embryonic stem cell.

(F.) The stem cell and the synergistic organizational matrices of therapeutic subject composition as seen in the healing, anti-inflammatory effect of the stem cell and its role in molecular embryology, genesis of embryonic stem cell in molecular embryology

These molecular biochemical steps of embryogenesis are identical to the molecular biochemical composition of matter of subject composition, and therefore the same activating biochemical molecules as the stem cell: 1. Cell membrane organizational matrix activation in cell membrane fusion of the sperm and egg, amphimixy in fertilization by the sperm's release of phospholipase to remove one fatty acid 'arm', providing an increase in hydrophilicity resulting in fusion of the membranes of the sperm and the egg.

2. Within a few minutes of sperm fertilization, the organizational matrix L-amino acid glycine, specified by the genetic code of protein synthesis along with the L phospholipid, serving to initiate cell membrane organizational system. Experimental tracking using radio- actively tagged free amino acids are now being incorporated into protein synthesis in the now activated metabolic, 'sleeping' egg. These sexual reproductive cells, active in meiosis, after fertilization, the anabolic enzymatic system of somatic cells have been initiated and mRNA production and translation, protein synthesis and the aerobic cell cycles are initiated, only to be momentarily interrupted by anaerobic mitosis and cleavage.

3. Upon cleavage of the embryonic stem cell, the production of the organizational extra-cellular matrix scaffold is activated. When filtered away, the cells fall apart, only to be reformed so that cell adherence organization can continue. Each step of embryogenesis can be arrested by similar experimental removal from arresting the life of the cell itself, to arresting gastrulation and neurulation.

Subject composition is therapeutically represented here by mimicking human tissue and immunologic 'self with the use of bio-chemical equivalents of human tissue. Additionally, the precursor micronutrient microenvironment also mimics human tissue immunologic 'self. All these components have additionally been screened as to not cross the immuno-infiammatory surveillance barrier. As immunologic 'self, these components are bio-chemically invisible to the immuno-infiammatory surveillance system, the basis for their significant tolerance. This subject composition therapeutics activates the patient's own stem cells to promote healing and regeneration of tissue. This therapeutics also includes the activation of protein synthesis, with anti-inflammatory activity reducing inflammatory cytokines, and associated chemo-attractant activity along. It also activates antagonist interleukin inflammatory receptor and associated activation of the immune protective system. The subject composition therapeutics and its components approach, derived from mimicking human tissue, and the healing system of human tissue, corresponds to the activation of the genesis of the embryonic stem cell shown above such as:

1. Organizational cell membrane phospholipids

2. Activation of the organizational protein synthesis system by use of L amino acids in protein specified by the genetic code, in stimulating the protein synthesis production of targeted protein such as developmental protein mimicking human tissue's breast milk protein.

3. Activation of the extra cellular matrix system with the use of ECM components such as, but not limited to, glycosaminoglycans, collagen, cartilage, chondroitin sulfate, glycoprotein and proteoglycan. Subject composition further includes synergistic micronutrient microenvironment, vitamins such as Vitamin A, vitamin D; minerals such as zinc; essential lipids such as (and with particular reference to) Omega 3 fatty acid fats.

Therapeutic problem to be solved: by tracking with histopathology of disease and tissue breakdown, revealing similar initiation of breakdown of cell membrane and associated abnormal increased permeability and loss of cytoplasmic content. This is all without the risk of undesirable effects such as transdiffercntiation, mutagenesis, and concerns of disease transmission. No known undesirable effects including avoidance, or significantly minimizing steroid requirements and dependency. The added beneficial therapeutic effects include significant steroid sparing. Another added advantage is avoidance or significantly minimizing steroid requirements and dependency.

The Stem Cell Solution of: Activation of the patient's own stem cells with therapeutic subject composition of matter.

The therapeutic subject composition, breakthrough activates, non-invasively, the patient's own stem cells, allowing the cells to thrive in-vivo, or in-vitro, without any apparent risks. This includes 247 case reports clinical, in-vivo, and in-vitro studies.

(G.) Congenital biliary atresia.

The present invention is particularly effective for treating congenital biliary atresia, a stem cell focused disease. A small population of stem cells located in the junction between liver cells and the smallest segments of the biliary tree (as shown in FIG. 1) ma)' differentiate into liver cells and biliary duct epithelium. These hepato biliary cells are known to participate in regeneration that occurs in certain forms of hepatitis. Thus, in congenital biliary atresia, the stem cells are able to grow new tissue located in close proximity to the damaged tissue. The damaged tissue, as shown in FlG. 1, has periductular inflammation and fibrosis. The focus of maximal disease is at the junction of the smallest ductules of the biliary tree and the adjacent liver cells (hepatocytes). This is also the location of stem cells that are capable of regenerating liver tissue cells.

(H.) Bronchial asthma

The invention is also effective for treating bronchial asthma. Without being bound by any theory, the disease is believed to be similar to congenital biliary atresia, because it results in inflammation or blockage of small tubules that probably are in close proximity to stem cells. In bronchial asthma, the blockage occurs in very small tubules or bronchioles, which are unprotected by the support of cartilage in contrast to the remainder of the bronchial tree. Dramatic relief from asthma symptoms has been observed in asthmatic patients, usually young children that are receiving elemental feedings, as complete nutritional support, because of cow milk allergies. Furthermore, such patients have not been observed to suffer from 'dismodeling', a term used herein as a synonym for remodeling. Such patients are able to discontinue or reduce the use of inhalation therapy of corticosteroids and bronchodilators. These therapeutic compositions, according to the present invention, should help reduce the risks of adverse reactions associated with the use of certain allergenic plasticizcrs in renal dialysis. Thereby this therapeutic prevents recurrent anaphylaxis in dialysis, and eliminates acute flare-ups. Furthermore, this therapeutic composition is believed useful in reducing the risk of kidney transplantation rejection.

(1.) Crohn's Disease

Without being bound to any theory, it is thought that the essential components of the therapeutic formulations promote favorable substrate nutrition in-vivo, as well as in- vitro, for stem cells to thrive in tissue repair, replacement and regeneration. Such effects are believed to occur in mesodermal and mesenchymal tissue, as well as endodermal surfaces, such as the respiratory tract. Ailments of the GI tract such as regional ileitis (Crohn's Disease), and other inflammatory bowel diseases, including ulcerative colitis, mucous colitis, and liver disease such as, but not limited to, congenital biliary atresia, are all believed to be amenable to treatment with the inventive formulations and therapy. The inventive therapy is particularly advantageous for inflammatory bowel diseases that are very resistant to present therapies.

Furthermore, the simultaneous administration of components of the therapeutic formulations is believed to work synergistically to promote tissue healing at higher levels and at a more rapid speed than if the components were administered individually at different times. In particular, the administration of a combination of L-amino acids is believed to be much more effective therapy than administration of the same amounts of individual amino acids over time; as the individual amino acids are not concurrently in the blood stream.

(J.) Leprosy The inventive non-invasive therapy can also be used in the treatment of deforming diseases, such as leprosy, and skin and nerve damage. Bacterial infections and epidemics, such as drug resistant tuberculosis epidemics, may also be treated with a therapeutic formulation in which the components mimic the components of an antibiotic.

(K.) Dermatologic Diseases

Diseases of the ectodermal surfaces including skin, hair, nails and teeth, are amenable to amelioration by use of the inventive compositions and therapy. In particular, eczema, urticaria and psoriasis may be treated. The therapeutic formulations according to the present invention, can accelerate healing and reduce the risks of e.g. corneal graft rejection.

Noteworthy, is the therapeutic response in the patient age 80, who also had a persistent fungal infection of several months duration, in the right medial corner of his middle finger nail and nail bed (ungual tinea infection). The treated area (fortunately but initially unintentionally included in application to this area while applying the foregoing to the right arm torn rotator cuff area of damaged tissue) returned to normal in a few weeks, with normal re-growth of nail. Since unintentional and inadvertent initially, this might be looked upon as a variant of a blind therapeutic application with clinical response to chronic fungal (tinea), otherwise unresponsive to treatment. See also therapeutic details of this example in Torn

Rotator Cuff in group of, musculo-skeletal disease cases, Example 14.

Diseases akin to congenital biliary atresia from a therapeutic standpoint (e.g., ileitis) will show dramatic results from the present invention. For example, a patient that has ileitis will not require corticosteroids for as long as 7 months after therapy when this therapeutic formulation has been administered successfully and discontinued.

In the aging process, when the production of digestive enzymes and growth hormone is diminished, the free amino acids of the inventive, non-invasive therapeutic composition, are anabolic and stimulate production of growth hoπnones, which are both beneficial.

The inventive therapeutic formulations of the present invention may be used to drive anabolic processes for immunopathies such as milk allergies, colitis, and autoimmune diseases.

The inventive therapeutic formulations of the present invention may be used to provide treatment for burns. This subject composition therapeutics, such as transdermal lotion, has been effective in reversing the effects of severe bums of the skin.

(L.) AIDS and therapeutic subject composition

Furthermore, it is believed that the therapeutic formulations of the present invention can be used with AIDS patients on antiprotease drugs as a substrate analog and metabolic analog. Without limiting the invention in any way, it is believed that by administering the therapeutic formulations of the present invention and avoiding or minimizing ingestion of foods containing protein or peptides or containing microorganism metabolites or catabolic products (such as dairy products), the patient's recovery will be enhanced for the following reasons. The gastrointestinal (GI) tract will be only minimally occupied in proteolysis of exogenous proteins, and will still serve its inimune-like functions, such as controlling microorganisms (an antibiotic-like function), fight viruses, and aid in the repair of injured tissue permitting tissue healing. AIDS patients on conventional anti-proteasc drugs often have extreme hyperlipidemia, with serum triglyceride levels of 3,000 to 6,000 mg %. The conventional anti-protease medication may need to be withdrawn to protect the heart and blood vessels from the medication's side-effects, such as coronary artery disease. Administration of the therapeutic formulations of the present invention to AIDS patients on antiprotease drugs with concurrent avoidance of ingestion of the foods described above is expected to solve this dilemma. It is also expected to reduce the undesirable side effects of the drugs because the GI tract will only be minimally involved in protein breakdown or proteolytic action. It is believed that the proteases throughout the body will be coerced by the law of mass action into cell and tissue anabolism.

It is further believed that the therapeutic formulations of the invention can be used as a supplement to antiprotease therapy, and thereby allow for antiprotease dosages to be lessened and their side effects reduced while achieving the same therapeutic results. Preferably, AIDS patients on the inventive therapy should avoid ingesting catabolic products of microorganisms including their metabolites such as bacterial proteins and their metabolites, with exception of therapeutic effect as in subject composition of probiotic lactic acid bacteria, including dairy products. Furthermore, it is believed that the inventive formulations will act to repair HIV-damaged cells and tissue by supplying the building blocks needed, namely, amino acids, cell wall components, and extracellular matrix components. By the administration of these building blocks together in one formulation, it is believed that the components will act synergistically to allow for much faster and more complete cell and tissue repair than if administered separately. Without intending to limit the invention in any way, it is believed that the law of mass action will apply and cause proteases throughout the body to create proteins, rather than degrade them.

(M.) Immuno-therapeutics, an adjuvant to vaccine therapy as well as anti-cancer vaccine therapy Therapeutic subject composition cell/tissue immune function, nanotechnology therapeutics, is especially adaptable to co-use with anticancer vaccines. Its in-vitro, and in- vivo, anticancer activity has also been shown to significantly reduce cancer tissue and its antigenic presence, along with increase immune response. A very favorable bio- pharmacologic immunologic anti-cancer response strategy has evolved here including immunogenic adjuvant, along with several file patents therapeutic composition of matter.

The pharmacodynamics and subject therapeutic composilion-of-matter protected by issued patent claims results in cell/tissue immunologic healing through the production, in- vivo, of DNA, RNA and protoplasmic tissue protein. This therapeutics provides the pharmacodynamics of cell and tissue healing, repair and regeneration with significant antiinflammatory activity and reduction in chemical mediator chemo attractant inflammatory cytokines, uniquely associated with the stimulus of protein synthesis in healing.

Tissue healing integrity, strength and resilience result, being first initiated by normalization of the cell membrane receptor system.

This occurs by mimicking human or animal tissue respectively, using biochemical equivalent components, FD A pre-approved-as -safe, and further immunologically screened so as not to cross the immuno-inflammatory surveillance barrier. Also, this is the case of mimicking the embryonic stem cells from which all cell/tissue originate. The pharmacologic impact of subject composition therapeutics cell free microenvironment can best be seen with this diagram of the progressive development of the embryonic stem cell. (Non-invasively applied in anabolic tissue healing stimulation of protein synthesis and inhibiting the chemical mediators of inflammation and associated anti-inflammatory activity.)

Of 70 studies, of the foregoing 247 clinical and preclinical studies of diseases of poor or guarded prognosis, representing 44 bio-chemicals, 27% (12 of 44) dramatized a 3-D biochemical trend. This trend is also computerizable and provides positive therapeutic results, killing in excess of 88% of cancer tissue within 24 to 48 hours. Five (5) of these studies demonstrated a cancer cell kill rate of 99% to 100% in the same time frame. This is particularly noteworthy since these results were achieved using FDA pre-approved-as-safe components comprising subject composition synthetic cell-free micro-environment therapeutics.

Each step represents a cell biology model of the normal process of the biochemistry of human tissue that has the capacity to reverse the diseased cell biology model:

Pilot study: Similar synergy and enhancement of therapeutic response and improvement of quality of life in end-stage cancer has been noted.

Subject composition therapeutics is a product of bio-chemical engineering of cell/tissue immune functionality. It has the anabolic design of human tissue (and other mammalian tissue). This therapeutics provides the pharmacodynamics of cell and tissue healing, repair and regeneration with significant anti-inflammatory activity and reduction in chemical mediator chemo-attractant inflammatory cytokines, such as but not limited to IL 1 , IL 6, and

TNF. This therapeutics stimulates interleukin receptor antagonists of inflammation, uniquely associated with the stimulus of protein synthesis in healing.

Subject therapeutics composition immune therapy stimulates protein synthesis tissue healing, anti-inflammatory efficacy represented here by mimicking human tissue and immunologic 'self with the use of bio-chemical equivalents of human tissue. Additionally, the precursor micronutrient microenvironment also mimics human tissue immunologic 'self. All these components have additionally been screened as to not cross the immuno- inflammatory surveillance barrier. As immunologic 'self, these components are biochemically invisible to the immuno-inflammatory surveillance system, the basis for their significant tolerance. This subject composition therapeutics activates the patient's own stem cells, in promoting healing and regeneration of tissue, along with activation protein synthesis with anti-inflammatory activity reducing inflammatory cytokines and associated chcmo attractant activity. This therapeutics also activates antagonist to inflammatory receptor interleukin (ILlbeta) and associated activation of the immune protective system. The therapeutic subject composition approach that corresponds to the activation of the genesis of the embryonic stem cell shown above such as:

1. Organizational cell membrane phospholipids

2. Activation of the organizational protein synthesis system by use of L amino acids in protein specified by the genetic code, in stimulating the protein synthesis production of targeted protein such as developmental protein mimicking human tissue's breast milk protein. 3. Activation of the extra cellular matrix system with the use of ECM components such as, but not limited, to glycosaminoglycans, collagen, cartilage, chondroitin sulfate, glycoprotein and proteoglycan. Subject composition further includes synergistic micronutrient microenvironment, vitamins such as Vitamin A, vitamin D; minerals such as zinc; essential lipids such as and with particular reference to Omega 3 fatty acid fats. These FDA approved-as-safe components have withstood a remarkably significant test of time (from the perspective of drug discovery), and parallel the progressive history of development of biologies such as insulin for diabetes, or Bj₂ for pernicious anemia. The opportunity to augment immunotherapeutics in tissue integrity can be found in researching correctable deficiency studies of biomaterials provided in 19 composition of-matter claims as provided in 6,974,976 B 1. For example, in diabetes, whether type I or II, it is known in type I that there is a deficiency of insulin and in type II a deficiency in the receptor. This receptor has been identified in our research as chromium nicotinate provided for example, in the Carlson Vitamins, Arlington Heights, IL, Super 2 Daily vitamin and mineral soft gel with fish oil and lutein, in a dosage of 200 micrograms and Life Extension Products, Hollywood, FL Chromium Ultra, in a dosage of 500 micrograms). Not only does it improve insulin sensitivity but it also maintains the healthy systolic blood pressure and reduces oxidative stress. Studies in women have been associated with weight control, as well as optimizing and maximizing the subject composition's immunotherapeutic safety and efficacy to advance and normalize the biologic competition and tissue integrity, to augment and restore normalization required to prevent the complications (commonly found in the feet and legs) but not limited to diabetic infections. It is of paramount necessity for tissue healing of diabetic ulcer, as well as normalizing the degenerative changes associated with diabetes. Similar therapeutic response to atherosclerosis, (an important factor in diabetes), has been noted with subject composition.

Subject composition therapeutics offers an immunologic-based therapeutics with a broad and diverse range of therapeutic applications, applicable to noπnalization of tissue healing and associated innate immunity and anti-inflammatory activity. These include the reversal of intractable diseases such as, but not limited to, Crohn's disease, wound healing, and immunologic diseases spectrum that includes autoimmune diseases. These immunologic diseases range from the mild to the most severe and extreme. Subject composition therapeutics new cell/tissue immune efficacy and functionality includes traumatic and osteoarthritis and rheumatoid arthritis in human and large animals and cancer with its many organ system types.

This therapeutics is similar to existing immunologic-based broad range medication that also focuses upon persistent inflammatory diseases. Subject composition therapeutics is targeted to diseases such as Crohn's disease and rheumatoid arthritis.

Subject composition therapeutics and its variants are unique and proprietary, not only in the formulation, but also in the specialized ratios, colloidal emulsion, and balanced hydrophilicity, all derived from FDA pre-approved-as-safe components. Subject composition therapeutics has been defined by the FDA as a drug. It is administered orally in capsule or tablet form, topically in cream form, and intravenously. This therapeutics provides normalization of the immuno-inflammatory system concurrent with stimulation of healing repair and regeneration of diseased tissue.

This biologic efficiency and proven efficacy has been demonstrated here in more than 247 patients. It does not require a cell culture resource derive from a milieu that requires, e.g. a vat as in brewing beer, nor is this a cell or stem cell-derived product with concerns of variations in cell line.

Therefore, it is unlike animal or human derived antibody therapeutics, and does not cross the immuno-inflammatory passive surveillance barrier. Therefore it is free of serious side effects such as lymphoma, tuberculosis or multiple sclerosis. No known undesirable effects including avoidance, or significantly minimizing steroid requirements and dependency.

In fact, after tracking subject composition therapeutics and its progressive development over several decades, no known undesirable effects have been observed. This is attributed to subject composition therapeutics immunochemical medication design, which does not cross the immunologic inflammatory surveillance barrier system. It has a broader immunologic cell/tissue functionality range of enhancement.

The added beneficial therapeutic effects include significant steroid sparing with the added advantage of avoidance or significantly minimizing steroid requirements and dependency. Subject composition of matter lmmunotherapeutics as applied to: Enhancing functionality of vaccines and co-using with advances in cancer vaccines and immunotherapeutics subject composition of matter as a vaccine adjuvant. This results in enhancement of vaccine efficacy and safety in clinical risk management bridging research, development and production.

(N.) Coronary Artery Disease

Subject composition therapeutics has been useful in the management of coronary artery disease, not only in countering the atherosclerotic deposition of cholesterol, plaques, but also in prevention of fatal dysrhythmia. This pharmacologic mechanism has been applied here as illustrating the dual role of the Omega-3 fats in the management of cardiac disease.

The pharmacologic mechanisms therapeutic effects as components of subject composition therapeutics are related to the essential Omega-3 fatty acid fats and the organizational cell membrane component phospholipid. The unsaturated double bonds in the 2ⁿ carbons of glycerol esterified to the fatty acid, has been additionally helpful. We have found that the Omega-3 fats have been associated with reduction in blood cholesterol level. The cell biology model of prevention of fatal dysrhythmia with use of the Omega-3 fats fish oil and plankton derived in the beating isolated animal heart muscle, despite the cardiotoxins administered in the experimental model.

The bioelectric phenomena present in all tissue, is highly dependent upon subject compositions therapeutics organizational membrane matrix of phospholipid and Omega-3 essential fatty acid fats. The 3 alternating double bonds of the Omega-3 fatty acid fats generate a very similar pi electron cloud as the benzene ring. These 3 alternating double bonds have the added advantage in that this effect is compatible with this 3-D stereo fit of cell biology models and of human and mammalian tissue. They additionally move as delocalized pi electron bonds along the chain of the fatty acid. These electron clouds can foπn phase boundary potentials like the charges of static electricity in a capacitor. This bio electric capacitor is best exemplified by the phospholipids such as, phosphatidyl choline bilamellar liquid crystal micelle. This static electrical charge on the hydrophilic bilamellar outside layers creates this capacitor static electrical storage effect with the lipid hydrophobic insulating effect separation.

This effect has been used therapeutically, for the prevention of fatal dysrhythmia such as ventricular fibrillation using the animal model in managing atherosclerotic coronary artery disease.

This same principle has been applied therapeutically to treat and prevent convulsions analog to "cerebral fibrillation" in the animal and patient that has epilepsy with the use of organizational cell membrane matrix, phospholipid such as phosphatidyl choline.

These essential lipids, as the foregoing, hold oxygen in cell membranes where the oxygen acts as a barrier to microorganisms such as viruses, bacteria and fungi. Also, these essential lipids are involved in making oxygen available for tissues by activating or opening the oxygen molecule in the form of electro-static forces, regulated by sulfur containing proteins. Thereby helps maintain the fluidity of membranes, in association with phospholipid, phosphatidyl choline surface active activity. In addition to dispersing potential toxins to the external surfaces of the body for excretion, they also help all proteins in the membrane by electro-static forces of their double bonds. They are also involved in such functions as the protein cell membrane channels, and pumps. These potentials across cell membranes are important in all cell membrane function signaling systems with particular reference to the heart, nervous system, and musculoskeletal system. This bio electric signaling phenomena is a component part of the stereo 3-D organizational matrix of subject composition therapeutics. The cell membrane organizational matrix containing phospholipid has another important advantage that of fluidity in enhancing blood flow. This enhancement of transmission of oxygen is therefore effective in treating diseases with potential hypoxia, such as coronary artery disease. An added advantage is a 25% increase in blood flow because of enhanced elasticity of the red blood cell membrane facilitating the passage and thereby oxygenation in these small channeled blood vessels and capillaries when used in dosages of 1.8 grams daily for 30 days of phosphatidyl choline. Additionally, the phytosterols, or plant sterols, such as beta sitosterol, campesterol and stigmasterol, play a therapeutic competitive role in reducing the level of cholesterol.

With each reduction in homocysteine of 4 mg%, there is a decrease by almost 20% in predisposition to coronary artery disease. This is therapeutically accomplished with subject composition of matter by incorporating B-vitamins such as, folic acid, B-6 and B-12. The present invention thereby sustains and converts the potential abnormal L- amino acid homocysteine to its normal required 3-D stereo format of L cysteine or L methionine, the organizational matrices of the subject composition therapeutics L amino acids in non chiral glycine specified by the genetic code of targeted protein.

The lipotrophic effect of L carnitine appears to be related to its choline-like tertiary amine component with similar effects and surfactant effects such as phosphatidyl choline. This effect in conjunction with co-enzyme Q-10 makes lipids more available for mitochondrial utilization in aerobic metabolism. Co-enzyme Q- 10 has also been found to be useful in reducing predisposition to metastasize and its blood level has been found proportionate to that anti -metastasis factor. (See the following, Anticancer Therapeutics).

(O.) Anticancer Therapeutics

It has been found that the compositions of the subject invention can normalize genomic expression, and are adaptable for anti- cancer chemo- therapeutics. The findings are based on utilization of FDA pre-approved as safe components which not only normalize the genomic expression, but also can normalize the abnormal cell cycle of cancer so that the cancer may proceed to scheduled end -of- life cycle and cell death. At first it seems counter intuitive that a safe product should be lethal to any tissue. However, the mechanism of this proprietary composition is to normalize and mimic human tissue or other mammalian tissue and to normalize its healing capacity. In normalizing cancer's healing capacity, it has found by the inventor that the cancer cell is stuck or arrested in a cycle that does not permit its scheduled apoptosis or cell death. By normalizing this cell cycle the cell is able to proceed to its cell death. In applying subject composition to the anticancer therapeutic applications of subject composition organizational matrices, reversing cancer as illustrated in the 70 examples of apoptotic induction cancer cell death, is associated with the foregoing therapeutic subject composition derived form mimicking human tissue and mimicking human tissue's healing capacity using. . The transdermal therapy is effective in arthritis cited herein in repairing torn rotator cuff and in reversing traumatic arthritis and synovitis in the equine species. When applied in-vitro to a prostatic cancer cell culture the results was an 80% reduction in 24-48 hours of cancer cells mediated by activation of apoptosis. There was up to 99 to 100% human cancer cell lethality even though these biochemical component equivalents to human tissue were FDA approved-as-safe. 8 clinical cases of cancer all improved in terms of reversal of the severe fatigue in as short of time as 24 to 48 hours as shown in the cancer example cases. Also, the reversal of cancer tissue in the 7 to 10 day acute experiment of examples presented here where 2 of these patients had observable reduction in cancer tissue size. One patient, over several months' treatment, had objective CAT scan and PET scan findings of reversal of lung metastasis with complete reversal of this metastasis as observed by comparative follow- up PET scan. One patient with a superficially anal lesion followed with physical examination that included palpation was observed to have a 40 % reduction in anal cancer cell size in the 10 days of IV treatment with therapeutic composition of matter. Treatment was focused on normalizing the Hydrophilic/lipophilic balance (HLB) an effect that all of the organizational matrices liquid crystal of cell membrane polar surface active lipids, including the L phospholipids such as in phosphatidyl choline. The L amino acids in the molar ratio of targeted proteins of subject composition, comprises and includes developmental protein, such as, but not limited to, breast milk protein. The extra cellular matrix liquid crystal hydrophilic surfactant activity comprises hydrophilic component functionality moieties, such as sulfated and glycosylated polysaccharides, in addition to the protein's hydrophobic CH₂ chains. This hydrophobic component of the surfactant effect resides in the protein's 2, 3, 4, or 5 CH₂ hydrophobic chains, of polymerized amino acid monomers, comprising the synthesized proteins. This comprises the 1 to 3 sulfate bonds per 2 disaccharide components of glycosaminoglycans (GAG) similar to the sulfate found among the highest hydrophilic surfactants, such as sodium lauryl sulfate, and the glucose molecules added by glycosylation by the cytoplasmic Golgi apparatus.

The analog cell biology model for the pharmacodynamics and pharmacologic basis for this unique application is exemplified as follows. Example of an anticancer therapeutics cell biology model and basis for therapeutic advance in treatment: The initial study of comparative microscopy of (1.) remarkably similar configuration of the characteristic cell of cancer with the lipophilic micelle liquid crystal configuration when adjacently placed for comparative study. It is believed this colloidal emulsion technology domain structural geometric microscopic configuration that the foregoing lipophilic micelle and characteristic cell of cancer phase; also share (2.) functional biophysical colloidal emulsion technology parameters. These commonalities appear to offer a cell and micelle biology therapeutic opportunities in reversing and normalizing the enigma of cancer tissue and its clinical consequences.

The therapeutic concept of reversing the highly lipophilic functionality to a progressively more obverse hydrophilic colloidal emulsion technology state, provided a therapeutic working model to study this significant therapeutic potential opportunity in-vitro and in-vivo. Additionally, the colloidal emulsion technology biophysical parameters illustrated in diagram 1, figure 1, were found useful to direct successful therapy in a disease with formerly very pessimistic poor prognosis therapeutic opportunities. This has been further established providing the selectivity potential for a non invasive therapeutics to enhance the therapeutic response and prognosis in diseases that now include cancer.

Of 70 studies of the foregoing 247 clinical and preclinical studies, representing 44 bio-chemicals, 27% (12 of 44) demonstrated a 3-D bio-chemical trend. This trend is also cυmputerizable and provides positive therapeutic results, killing in excess of 88% of cancer tissue within 24 to 48 hours. Five (5) of these studies demonstrated a cancer cell kill rate of 99% to 100% in the same time frame. This is particularly noteworthy since these results were achieved using FDA pre-approved-as-safe components comprising subject composition therapeutic synthetic cell-like micro-environment therapeutics.

Including additional data of hydrophilic components in their entirety represents therapeutic subject composition components. The additional 2, as seen in the enclosed in- vitro anticancer study example tables of 73% and 83% efficacy, would increase the yield of this drug discovery study to 12 of 44, or 31%. It is even more significant when one considers that these organizational component matrices of therapeutic composition of matter are being used here synergistically. Therefore we would expect a synergistic anti-cancer therapeutic efficacy based on the progressive development of this anti-cancer therapeutics as presented here. Presented in Goodman & Gilman's Pharmacological Basis of Therapeutics. McGraw Hill, New York, US & Oxford, UK. 2001 p.256-257; herein incorporated in its entirety by reference.

"Metabolic trauma associated with addiction"

"Amino Acids. The CNS contains uniquely high concentrations of certain amino acid, notably glutamate and gamma-aminobutyrate (GABA): these amino acids are extremely potent in their ability to alter neuronal discharge. However, many physiologists were extremely reluctant to accept these simple substances as central neurotransmitters. This reluctance was based in part on conceptual problems of how to discriminate amino acids acting as transmitters from the same compounds acting as precursors for protein synthesis." "the dicarboxylic amino acids produced excitation and the monocarboxylic ω-amino acids (e.g. GABA, glycine, β-alanine, taurine)." "Glycine is the most abundant amino acid with inhibitory activity found in the ventral- quadrant grey matter of the spinal cord, and concentrations of glycine drop in proportion to the degeneration of ventral-quadrant interneurons following transient ischemia of the cord.

In addition to maintaining normalcy and supply quantity of free amino acids as neurotransmitter precursors in the cerebrospinal fluid is optimized and maximized. This is also the case for the adjacent tissues of the gray and white matter of the brain, spinal cord and the cranial nerves as well as the nervesderived from the spinal cord and their sheaths. The free amino acids are also available for supply of proteomics and the normal proteomic array of protoplasmic nervous system protein. This, in turn, is derived from the templating and signaling system of the patient's genomics. This represents normalization, through the subject composition therapeutics which normalizes the polymerases enzyme proteins of DNA and RNA. In the same fashion, components of subject composition amino acids supply the ribosomal system at their entry point through transfer RNA. As a result, the cytoplasmic proteins are formed at the site of the free ribosomes. In addition, the endoplasmic reticulum ribosomes produce the secretory proteins. It is believed that the foregoing therapeutics reinforces anabolic metabolism of the nervous system and provides a normalized cycle of proteomics and associated proteins. This includes, but is not limited to, the normalized polymerases DNA and RNA resulting in a more normalized cycle of the genome and genomics. This is believed to minimize the lack of control addiction qualities of a patient addicted to drags With the use of this therapeutic composition, this belief is reinforced with similar findings suggestive of normalizing the abnormal genomics associated with predisposition to cancer. See for example the first twenty of one hundred and nineteen articles of research from the National Library of Medicine. In the first six articles, two of these cancer and drug associated articles provide a very clear cut relationship:

1. (Brooks PJ, Enoch MA, Goldman D, Li TK, Yokoyama A. The alcohol flushing response: an unrecognized risk factor for esophageal cancer from alcohol consumption. PLoS Med. 2009 Mar 24;6(3):e50. Review. No abstract available;

2. Wacholder S, Chatterjee N, Caporaso N. Intermediacy and gene-environment interaction: the example of CHRNA5-A3 region, smoking, nicotine dependence, and lung cancer, J Natl Cancer Inst. 2008 Nov 5;100(21):1488-91. Epub 2008 Oct 28. No abstract available; and

3. Yang L, Sun ZS, Zhu YP, Proteomic analysis of rat prefrontal cortext in three phases of morphine-induced conditioned place reference,. J Proteome Res. 2007 Jun;6(6):2239-47. Epub 2007 Apr 20.) (See also James D. Watson Institute of Genome Sciences, Zhejiang University, Hangzhou, Zhejiang, PR China:

Morphological alterations of synapse are found after morphine administration, suggesting that regulation of synaptic plasticity may be one of the mechanisms of neuro adaptation in addiction. However, the molecular basis underlying the abnormal synapse morphological and physiological changes in the morphine- induced dependence, withdraw, and relapse is not well understood. As prefrontal cortex (PFC) is one of the most important brain regions, which provides executive control over drug use and is severely impaired in many addicts, systematic analysis of the biochemical and molecular alteration of synaptic fraction of PFC in morphine-induced neuroadaptation is necessary. In this study, differential protein expression profiling of synaptic fraction of rat PFC based on morphine-induced conditioned place preference (CPP) model was performed with two-dimensional gel electrophoresis (2-DE). Our results showed that a total of 80 proteins were differentially expressed by 2-DE analysis during three phases of CPP assay. Of them, 58 were further identified by mass spectrometry. These proteins were classified into multiple categories, such as energy metabolism, signal transduction, synaptic transmission, cytoskeletal proteins, chaperones, and local synaptic protein synthetic machinery according to their biological functions. Our study provides a global view of synaptic-related molecular networking in PFC under morphine- induced dependence, withdraw, and relapse, indicative of a concerted biological process in neuroadaptation under chronic morphine exposure.)

Applicable to diseases resolution in regard to neurologic trauma such as spinal cord injury and quadriplegic the reversal of glycine deficiency included in subject composition to be included in the further applied research of these neurologic traumas. This therapeutics includes the use of advanced proteomics in protoplasmic protein advanced healing therapeutics in conjunction with redirecting the persistent and aggressive immuno- inflammatory system resulting in a significant increase in an ti -inflammatory receptor antagonists along with equivalent decrease of inflammatory protein interleukins (cytokines). This FDA approved therapeutics is steroid sparing/substitute. Further evidence of the most advanced principles of proteomics applied to immunotherapeutics would be IPFs immunotherapeutic agent (IA). As a result, this therapeutics is immunologically privileged and adapts well to crossing multiplicity of species barriers as well as disease cell lines.

The practicalization of reversal of neurological disease and normalizing homeostasis are provided in the deficiencies our research includes; drug addiction associated with spinal fluid amino acid abnormalities that further include the findings of a pathogenic deviant of amino acid metabolism homocysteine with the implication of the use of subject composition immunotherapeutics in normalizing homocysteine and homeostasis of free amino acid and non-chiral glycine and potentially helping to reverse clinical findings and reestablish normal metabolic homeostasis of tissue of addiction in association with abnormalities of spinal fluid included individually itemized but not synergistically presented in composition in 75 research study publications and blood studies of amino acids further in more than 3,000 similar research study publications again without the synergy of subject composition guided by mimicking human tissue. These articles include disease such as but not limited to Parkinsonism, narcotic, alcoholism and depression in addiction in assessing the dopaminergic and glutamine ergic balance (all conditions when personal control mechanisms are diminished as well as persistence of compulsive addictive behaviors as well as neuro- pharmacologic factors that contribute to the development of this addiction). It is believed that subject composition will play a therapeutic role in helping to overcome drug addiction, relapse, drug abuse, neurobiology of drug dependence and relapse. See Figure 11.

These components in their synergistic totality mimicking human tissue are representative of molecular embryology which we have found to be equivalent to tissue regeneration and disease resolution. Wc can see these components active in the progression of activating the stem cell (the sleeping egg) and EMC in tissue formation. First the phospholipids such as phosphatidyl choline are made more surface active at the site of injection of the sperm into the ovum phospholipid PC cell membrane and the phospholipase base acrosome. Thereby, one fatty acid arm has been removed and the ratio of hydrophilic** to lipophilic is balanced, or HLB hydrophilicity is increased greatly to H (hydrophilicity) of 2 to L (lipophilicity) of 1 into H (hydrophilicity) of 1 to L (lipophilicity) of 2, with an obverse HLB of 1 to 2. There is now only one fatty acid lipid molecular arm and one hydrophilic phosphocholine molecular arm. This activates the protein synthesis proteomic ribosomal system to now in 3-5 minutes after fertilization to show for the first time that amino acids radioactively tagged such as methionine are being incorporated into proteins. In 1-2 hours tissue is formed wherein the extracellular matrix formed and its glycoproteins, glucosamine glycine, chondroitin sulfate, glucosamine sulfate, hyaluronic acids, fibronectin, collagen, such as but not limited to laminin and fibronectrin. Filtered away as has been experimentally in the sponge the cells fall apart only to reform this extracellular matrix and become unified cells and tissue again in a few hours (1-2 hours). This glycoprotein has been glycosylated in the Golgi and sulfated for strength as sulfated polymer of nylon Kevlar becoming analog to bullet proof material for a vest. This component give the tissues the added tensile strength up to 42% greater than controls when used here as a synergistic component in healing. This can not be done by and inert glue only this matrix can contain information and organization of cells which we have stated is important not only for growth and development but for wound and disease healing the focus of this therapeutics. This extracellular matrix directs organization attachment differentiation due to the information it contains as well as signaling. Hence, this subject composition represents not only a stem cell stimulus but also a stem cell growth factor. This has been expressed by PTO approval and registration of these trademarks which explain this therapeutic activity such as Stem Cell Repair Kit, Cell Bio Chem Repair Kit and Syntheticell. Another term we have used and explained in the introduction of this text is the proteomic array. This multiplicity of action of each of these components can be seen for example in the amino acids because they represent in addition to the foregoing synthesis of protein components that have neurotransmitter ability such as the inhibitors the monocarboxylic, amino acid, gamma-aminobutyrate, glycine, alanine and taurine. The excitatory factors include the dicarboxylic amino acids such as glutamine.

In the case of breast milk which has replaced the placental feeding of the embryo and fetus. Particularly, noteworthy in the human is responsible in synergistic association with the other components of subject composition to impart progressively to the newborn so that at age one the newborn can now walk and talk. This is not the case for animals that have all of their neurologic skills at birth or maybe 15 minutes after birth such as the colt and calf. In fact the newborn represents a normal physiologic equivalent to quadriplegic (representative of the Christopher Reeve's Syndrome) as in the newborn infant child is not even able to raise its head until three months. At three months the child can raise its head, six months the child can sit up, at nine months pull up to a stand and at twelve months it can initiate talking, crawling and walking. It is believed these principles should be considered neuropathogenesis and treatment of autism, since autism frequently appears at age one, the common age of weaning from breast milk. This breast milk is represented here in the molar ration Ic: a plurality of amino acids having an alpha carbon, the amino acids being present at a molar ratio which is characteristic of human breast milk protein, and wherein nor more than 10% of the amino acids are in D-form. Breast milk also has phospholipid such as phosphatidyl choline and actual cells and tissue additionally represented by the extracellular matrix and micronutrients of vitamins and minerals of subject composition.

This now allows us to better appreciate the amino acids and the neurotransmitter activity as well protoplasmic protein and proteomics healing activity. It has been estimated that nearly 90% of the brain catecholamine are synthesized directly from tyrosine.

The aromatic amino acids, tryptophan, phenylalanine and tyrosine which can be respectively converted to serotonin 5 hydroxytryptamine, which is five hydroxylated and decarboxylated tryptophan This conversion is dependent upon adequate presence of B6 and magnesium and is interfered with insensitivity to insulin. Phenylalanine (and/or tyrosine) can be hydroxylated to dihydroxyphenylalanine which in turn can be decarboxylated metabolically in the body to dopamine which is mainly dihydroxyphenylalanine can be converted to neuro-epinephrme and when methylated can be converted to epinephrine. Acetylcholine provides a source of free choline pool from which the neurotransmitter acetylcholine is synthesized and may be derived from enzymatic hydrolysis of lecithin and sphingomyelin.

In molecular embryology neurologic development or neurulation has been found to be dependent on the extracellular matrix in addition to its importance of making tissue adherence signaling organization migration possible (in contrast to inert glue like matrix). Since this process can be arrested by surgical removal or cellophane isolation of the extracellular matrix from the rest of the embryonic tissue. These macromolecules are permitted to be released through the Millipore filters., In fact, one on can see the this vine- like extracellular matrix glycoproteins growing into the rest of the tissue through this porosity of the Millipore filter. In fact the life itself of the starting embryo can be arrested by removing the mesodermal EMC wedge between the ectoderm and endoderm. When reinserted surgically, signaling is reestablished and life returns. In embryonic development EMC presence prevents the arrest of gastrulation and neurulation. It is believed applicable in the same fashion to gastrointestinal and neurologic disease resolution. When one considers these developmental features it become imperative to include this biochemical features and synergism of subject composition along with the micronutrients serve as antioxidants, coenzymes and catalyst wherein the minerals with such functions as serving as catalyst and the vitamins serve with such catalytic protein enzyme capabilities included in their function such as coenzymes. This instrumentation that we have shown through CRI (Cambridge Research Institute) is dependent upon liquid crystal hydrophilicity and its associated biophysical features of birefringence of polarizing light. It is believed that this can be a marker for normal tissue in contrast for example to cancer (in that cancer has the lipophilic micelles). This foregoing hydrophilicity can be used as a detectable measuring stick of normal tissue activity by polarizing light probe using polarizing fiber optic cables to carry the light from the polarizing probe serving as a mini polarizing microscope that is heated to 37 degrees centigrade and will carry this light message to the computer chip adapted to read quantitatively the degree birefringence luminescence. This serves as a non-invasive tracking system for therapeutic comparative efficacy of medication and minimizes the need for animal studies as well as serving as a non-invasive equivalent to biopsy in the case of cancer.

Tissue might be considered analog to an alloy and this analog of the biophysics of human tissue measure with the instrumentation we proposed might be compared to the tone bell alloy of copper. When copper contains 10% tin it has been continually observed that it has the greatest tone qualities as a bell. The ratios and synergy including the birefringence light response might be considered analog to tone bell copper and the beautiful sounds of the tone bell copper bell.

Additionally, this high degree of anti-cancer therapeutic safety, along with anticancer therapeutic efficacy, is emphasized here. These results are derived from components based on mimicking human tissue through the use of biochemical equivalents of human tissue that are all FD A pre-approved-as-safe. This is therefore contributing to anticancer therapy based on these cell and micelle models and at the same time significantly reducing the risk, if any, in the use of these compounds in the management of cancer. If we include all the components so directed by using therapeutic subject composition, as they also have hydrophilic activity and associated anti-cancer activity, then we have an efficacy that starts with 73% anti-cancer activity.

In the case of the organizational extra-cellular matrix bovine collagen, derived from bovine tracheal cartilage, or cartilage derived from the shark, possess the anti-cancer activity of therapeutic subject composition. The foregoing bovine cartilage has an 80% anti-cancer efficacy in 24-48 hours cancer cell kill efficacy.

This anticancer activity cell-kill efficacy of 0.125 % (polysorbate 80) Tween 80 of 76 % is also similar to the 83% anticancer cell-kill efficacy of precursor L amino acids and glycine, grape seed extract in the molar ratio of developmental protein, which enhances the structural and functional completion of neurologic and other organ development from newborn to infant age one. L lysine, the highly hydrophilic amino acid component of the foregoing amino acid molar ratio of developmental protein, and has a 99 to 100% anticancer kill rate. When used synergistically with organizational cell membrane matrix component of therapeutic subject composition of matter of egg yolk phospholipid emulsion 1.2% diluted 1 :80, there is an anticancer efficacy of 88 %. With the added advantage of these components being FD A pre-approved-as-safe, significant anti cancer therapeutic potential arises.

The foregoing is statistically significant particularly if you consider the fact that the current technology of early stage drug discovery utilizes comparative biochemical structures and through computer search commonly requires 3 million studies so that one single chemical might be found to provide anti-cancer healing activities. If we add the criteria of drug discovery used in the development of this composition of matter into the computer search, the yield would be even significantly less. For example, to achieve this degree of safety, another computer search would have to be superimposed. This would further include a track record of safety over several decades as in this subject composition of matter. Therefore the yield of available compounds would be significantly lessened. If the criteria of the computer search further included simultaneously mimicking human tissue and immunologic 'self as biochemical equivalents of human tissue and its micronutrient and microenvironment of immunologic self, this would significantly lessen the yield of potential new compounds derived from computer search in contrast to inventive therapeutics derived by replication of human and other mammalian tissue

Associated liquid crystal micelle parameters, are seen in diagram 1, figure 1, of a colloidal emulsion. In addition to these analog geometric microscopic configurations, associated parameters of the characteristic cell of cancer and lipophilic liquid crystal micelle geometric microscopic configuration, associated parameters are seen in the foregoing diagram 1 figure 1. These associated parameters, of anticancer hydrophilicity such as: the higher hydrophilic lipophilic balance mathematical ratios (HLB) of 8 to 10, as is the case of the organizational cell matrix of therapeutic subject composition of matter such as phospholipid phosphatidyl choline (Bilamellar) approximate HLB 8 to 10 with an anticancer kill rate effect 88% in 24 to 48 hours in-vitro study. This concurs with a reduction in cancer size in the 10 day acute experiments as seen in the most superficial anal cancers treated of 40%, using the bilamellar phospholipid hydrophilicity with an HLB in the range of 8 to 10.

This is in contrast to the lipophilic micelle of HLB of 6 or less whose micelle is characteristic of cancer. Additionally, the cancer cells have a characteristic deficiency of hydrophilic phospholipid evidence by the complete absence of the nuclear membrane and its associated nucleolus and nucleolar membrane. This is further evidenced by the condensed DNA chromatin characteristic of very prolonged mitotic changes characteristic of cancer (not seen by the histopathologist in normal instantaneous mitosis required for cell cleavage throughout the body). These phospholipid deficiencies are believed to be detectable with newly proposed polarizing light instrumentation.

In the case of the even higher hydrophilic surfactants, with even more concentrated, and effective, anticancer activity, the HLB is greater than 13 to 20 and 20+. These in-vitro 24 to 48 hour, anticancer kill rate effects are 98% or greater using high hydrophilicity surfactants, such as Tween 80 or Tween 65, with a concentration of 1%. In the case of the highest hydrophilicity, 20 to 20+, the effects are 100% anticancer kill rate, using a concentration of as little as 0.25%, such as sodium lauryl sulfate. These hydrophilic parameters are further described by the highly hydratcd and highly packed surfactant surface density. This is expressed as the surfactant packing parameter density of 0.5 to 1 as in the case of the cell membrane phospholipid. This indicates the greater packing parameter providing the smaller denser micelle than the lipophilic micelle, which has an index greater than 1. The surfactant packing parameter of the liquid crystal micelles with the most concentrated anti-cancer cell kill efficacy has the greatest surfactant packing parameter efficacy indicated by the smallest micelle indicated by a packing parameter of less than 0.5. This is the case of the highest hydrophilicity surfactants with a very high hydrophilic lipophilic balance ratio (HLB) of greater than 13 to 20 and 20+ (as depicted in diagram 1, figure 1.) The mathematical ratio is provided here for the mathematical formula of surfactant packing number). The surfactant packing number derived from the mathematical formula Ns = WIa₀ where (v) and (1) represent the volume and length of the lipophilic hydrocarbon chains and (a) is the area of the hydrophilic polar group. These ratios and mathematical formulas are emphasizing the repulsion between the uncharged surfactant coated surfaces and depend on the hydrophilicity of the surfactant and packing density. At the surface, a well balanced emulsifier should be well hydrated and packed densely on a surface in order to give rise to strong repulsive hydrophilic hydration anionically charged forces. These hydrophilic surfactant parameters explain and characterize the bio physics of the anticancer kill efficacy proportionate to increasing hydrophilicity and microscopic aggregate geometry and the associated hydrophilic parameters. (Ia) I have found when water was added to the surfactant system, such as this egg yolk phospholipid surfactant system, it became more effective in the result anti-cancer activity, increasing the interfacial surfactant system surface. This hydrophilic surfactant further activates the enzyme catalytic system, therefore in accelerating these reactions, it has catalytic function to the enzymatic catalyst for the enzyme catalyst, specific for designated substrates, such as the caspaces critical for the apoptosis dissolution of the cell (Not found in the prior art). The cancer cells, as seen in diagram 1, figure 1, are the histopathologic examination of the characteristic cell of cancer, such as, but not limited to, breast cancer cells that have metastasized to the spinal fluid. All types of cancers have this characteristic cell. It is believed to be amenable to this fluid histopathologic examination with the arrows pointing to the cancer cell.

(Ib) This therapeutic hydrophilic surfactant efficacy can be synergistically reinforced by the other organizational matrices. This comprises the L amino acids and glycine specified by the genetic code of developmental protein such as, human breast milk. The anticancer kill rate efficacy is 83% in a 24 to 48 hour in-vitro study. The highly hydrophilic L amino acid surfactants such as L Lysine, has an anticancer kill rate of 99 to 100%. These L amino acids and glycine have comparative HLB values which can also be programmed from a hydrophilicity standpoint. These pre-protein amino acids are specified by the genetic code of the therapeutically targeted protein, and used accordingly in specific molar ratios, also specified by the genetic code.

Additionally the extracellular organization matrix ECM also has hydrophilic HLB features such as the hydrophilic glycosylated carbohydrates, (glycosylated in the Golgi apparatus of the cytoplasm). Also these ECM components such as GAG (glycosaminoglycans) and proteoglycans glycoproteins are made further hydrophilic by being sulfate, (also analog to the sulfate in the most highly hydrophilic surfactants, such as sodium lauryl sulfate with the highest possible HLB of 20.

(Ic) Regardless of the type of cancer, the cell characteristic of cancer is microscopically studied and compared with the colloidal emulsion technology of the microscopic characteristics of its micelle. I unexpectedly found very similar structural morphology of cancer with the lipophilic micelles

(2.) Characteristic of cancer: missing any nuclear organizational cell membrane consisting of phospholipid phosphatidyl choline, without a nucleolus and its nucleolear membrane organizational phospholipid phosphatidyl choline to form messenger RNA (mRNA) templated from nuclear DNA.

(3.) Since condensed DNA chromatin has also been found to be characteristic of cells destined for apoptosis cell cycle, it is believed this cancer cell is also scheduled for apoptosis.

However, it is 'stuck' and not able to complete the programmed cell death or complete its cell apoptosis. This is in keeping with cancer being deficient in the self limiting apoptotic cell cycle mechanism, also limiting excess proliferation of cells characteristic of cancer.

(4.) Utilizing these three featured inter-relations regarding cancer it was thought by exposing the cancer cells to the hydrophilic surfactants shown in the upper 2/3 of diagram 1 , figure 1, as seen in the bilamellar phase and in this small spherical aggregate phase of extreme hydrophilicity and associated parameters, that this would alter and normalize the characteristic cells of cancer. This is analog to the structure and associated parameters as seen in diagram 1, figure 1, of the lipophilic micelle and its associated parameters. This is also analog in structural appearance to the characteristic cell of cancer. It has been found with 71 pre-clinical in- vitro studies and about 15 clinical that these FDA pre-approved-as-safe hydrophilic surfactants are representative of a treatment for cancer. The examples of these anti cancer therapeutics results derived there from are shown here.

(5.) These hydrophilic surfactants are used therapeutically in subject composition in order to modify the structure, and therefore the function, of similar lipophilic liquid crystal type of micelle aggregation and associated parameters shown in diagram 1 figure 1. It is believed these findings have been noted in biologic emulsions such as human tissue. The hydrophilic surfactants studied in these examples, such as the components of subject composition, including the phospholipids as phosphatidyl choline therapeutically, enable apoptosis through polar surface acting hydrophilic surfactant phospholipid lubricant activation of micro-surfaces. This enables more intimate contact of substrate with hydrolytic enzymes such as caspase, to enhance their efficiency in the completion of this normal process of lethality to the cancer cell. It has been found that the compositions of the subject invention can cause a reduction in the tissue cell count of the cancer cells This occurs, it is believed, because of the proteomic production of the capsase enzyme therapeutically stimulated with subject compositon. The normal cell cycle of apoptosis as a result of the production of associated caspase enzymes, which has achieved in-vitro studies utilizing the HeIa cells (derived from the cancer cells of Helen Lane). 83% to 99-100% lethality has been determined by spectro-photometric studies as well as microscopic studies. All while adding normalization of flow to other cells and cell cycles. This will normalize the tissue flow and function of these liquid crystal structures including normalizing the structure and function of the condensed nonfunctional nuclear DNA chromatin (represented here as a product of the chromatin condensing factor) that all cell cycles have in common, including apoptosis.

(6.) We have shown that hydrophilicity of surfactants therapeutically reverses the lipophilicity, and thereby increases hydrophilic lipophilic balance (HLB) to 8 to 10. The cancer cell corresponds to the lipophilic micelle shown in this diagram with HLB of less than 6 along with other parameters shown on the diagrammatic chart. The more hydrophilic bilamellar phospholipid surfactant action therapeutically reversed these histopathologic cells including the cell characteristic of cancer as evidenced by the enclosed laboratory studies of these comparative cancer cells and equivalent micelles.

(7.) This lipophilic micelle had the structural 3-D stereo feature of the characteristic cell of all types of cancer. Therefore, the conclusion of the experiment was to utilize hydrophilic non-lipophilic micelles and their associated parameters. This comprises hydrophilic/lipophilic balance (HLB) of 8 to 10 as in the bilamellar micelles and the more hydrophilic micelles with an HLB of 13 or more, such as Tween 80 (polysorbate 80) up to 20 HLB and, such as sodium lauryl sulfate. All having an HLB in excess of 6 or less, characteristic of lipophilic micelle and corresponding associated surfactant packing parameters and numbers and mathematical formulations. It was felt through incorporating this biochemical insight, offered by this colloidal emulsion technology domain, that the histopathologic characteristic features of cancer could be reversed, non invasively regardless of the type of cancer. It was believed the associated cell cycles of mitosis, as well as the cell, could be normalized so that the characteristic cell did not appear as if it were 'stuck'. It was also believed the characteristic cell would be enabled to proceed to this enzymatically mediated apoptosis. It was found here to be further catalyzed by administration of these hydrophilic surfactant to achieve apoptosis and dissolution of the cancer cell non-invasively. This anticancer kill rate in 24 to 48 hour in-vitro studies were confirmed by spectrophotometric. and microscopic studies, comparative to no change in the control. All of this is being achieved by mimicking human tissue's immunologic 'self. This has been referred to as "tidy", since immunologic 'self and this therapeutics subject composition biochemical mimicking therapeutics also represents immunologic 'self. Immunologic 'self stresses biochemical 'invisibility' in that there is no biochemical or biophysical foreign chemical stimulus to produce inflammatory cytokines. Therefore this would be an induction of a life cycle such as apoptosis without inflammation.

(8.) With continued analysis of the foregoing hypothesis and results, it was found that each step represents a cell biology model of the normal process of the biochemistry of human tissue. It also, has the capacity to reverse the diseased cell biology model all with DNA chromatin condensation commonality and the associated cell cycle that corresponds to these models such as apoptosis. This normalization by hydrophilic surfactant of the subject composition therapeutics as indicated in the foregoing has the ability to enhance the interfacial association of enzyme and substrate. Thereby, enhancing in a catalytic like fashion, efficacy of enzyme dependent apoptosis through this pharmacologic mechanism of surface interaction of substrate and enzyme.

(9.) Apoptosis and programmed cell death are normal components of the life of cells and tissues to keep a homeostatic balance of genetically determined required cell population. For example, the life of the gastrointestinal track cells has been found to be 2 to 6 days. Apoptosis offers programmed cells death and re constitution of these cells and tissue. This utilization of apoptosis for the normal shaping of tissue may be exemplified in all phases of life, such as embryogenesis. Without the biochemical hydrophilic surfactant enhanced enzymatic shaping of tissue, normal apoptosis to counter webbed fingers, would not be possible. This was addressed by a molecular embryologic apoptotic removal of this webbed finger bridge. A continually recurrent cell cycle is necessary in maintaining normal cell and tissue vitality and cell count. This adaptation mechanism is being used in subject composition therapeutics offered here in an analog fashion as anticancer treatment and/or as an augmentation. It is believed this cell removal technology may minimize the need for cancer surgery and radiation oncology.

(10.) Further review of the apoptotic inducing activity of these hydrophilic surfactants, shows a positive correlation to their cytotoxic activity. This hydrophilic surfactant effect also shows a close connection between reversing the highly proliferative cancer cell growth inhibitions and inducing apoptotic programmed cell death. It is believed that cancer also represents dedifferentiation to the highly proliferative phase induced by the maternal or "early cleavage" histones.

(11.) This stage and cell cycle correspond to the cancer dedifferentiation and represent the mechanism of the extreme proliferation found in cancer and characteristic of the first 10 hours of embryogenesis from the fertilized egg to the 1,000/2,000 cell blastula stage of the developing embryo. There is a dramatic drop in mitotic index and associated cell proliferation that is characteristic of late or embryonic histones, present all through life and identical to adult histones as part of the chromatin DNA complex. (Molecular Embryology, J. Brachet and H. Alexandre, Springer-Verlag, New York, NY, 1986, page 96, Figure 43 & 44).

(12.) The enzymatic metabolic phase of subject therapeutic composition initiates the union of the cell membranes of the egg and sperm in amphimixy. Fertilization also activates the conversion of the metabolically 'sleeping' egg and sperm whose inactivation had been dependent upon DNA chromatin condensation, absent nuclear membrane, and nucleolus. Additionally, resistance to enzymatic digestion has been observed by the molecular embryologist whose experimental findings include resistance to nuclease enzymatic activity. This resistance to enzymatic digestion as with the nuclease enzyme is also noted in the sperm. This sperm is a precursor cell to the embryonic stem cell formed by the sperm fertilizing the egg. Both of these observations are believed to imply a deficiency of hydrophilic surfactant and suggestive of a lipophilic HLB and associated packing numbers that we have found characteristic of the lipophilic micelle and the cells characteristic of cancer. The resurgence of metabolic activity deactivates meiosis or mitosis and makes more hydrophilic in reversing the DNA chromatin condensation. This is seen within a few minutes after fertilization. The sperm's phospholipase fertilization activity removes one fatty acid arm of the phosphatidyl choline and makes it more hydrophilic. This is associated within a few minutes of initiation and onset of utilization of free amino acids as in subject composition, which also initiates protein synthesis. Protein synthesis and its stimulus by therapeutic subject composition, includes the formation of DNA polymerase and the formation of more DNA. These metabolic events maintain hydrophilicity and synergize enzymatic and metabolic activity. (J. Brachet and H. Alexandre, Springer-Verlag, New York, NY, page 100.)

(13.) It is further believed, in view of the progression of cell/tissue biologic events, subject composition therapeutics organizational cell membrane matrix, polar surface active lipid hydrophilicity, provides an anticancer therapeutics. The present invention is believed to be mediated through the pharmacologic mechanism of enhancing the hydrophilicity of mitotic changes of cells characteristic of cancer, that we have observed in-vitro, and in- vivo. Therefore, it is further believed that this subject composition therapeutics appears to greatly reduce the high mitotic index and high proliferation of cells associated with cancer. Additionally, we can better appreciate why these patients within 24 to 48 hours in the acute experiment of 7 to 10 days duration had resurgence in energy and did not want to go to the hospital or hospice. Such patients wanted to go home. It is believed that the activation of these metabolic events also activated aerobic metabolism in contrast to the anaerobic metabolism associated with 1) cancer, 2) mitosis and cleavage (1 and 2 having in common DNA chromatin condensation, absence of nuclear membrane and its organizational matrix phospholipids, such phosphatidyl choline, and absence of nucleus so that it is not possible for DNA, RNA, protein synthesis to occur). All of which are activated by therapeutic subject composition and its hydrophilicity. 3) bacteria and therefore bacterial infection, 4) In fact, this turn-off of enzymatic metabolic activity and aerobic oxygen consumption has been repeatedly observed by Zeuthen and occurs even at the end of every normal mitosis. This mitotic occurrence, associated with normal cell cleavage, is very momentary in humans and mammalian tissue, since this event is rarely seen histopathologically, except in cancer. This anaerobic phase has been associated with an increase in carbon dioxide and decrease in pH (J. Brachet and H. Alexandra, Springer- Verlag, New York, NY, page 91-92, quoting Zeuthen work on page 91 -92, including a tabulation of his work in Figure 39, page 92.)

The anaerobic respiration in contrast to its normalization in cancer with this therapeutic composition, can be better explained by the fact that only 24,000 calories of energy are produced by 2 moles of energy bearing ATP during this anaerobic phase, whether by cancer cells, or bacteria. These 24,000 calories were released by splitting. In aerobic metabolism, almost 20 times more calories of energy are produced:

432,000 calories are produced by 36 moles of ATP. Actually, 24,000 additional calories are produced if we add energy released by splitting 6 carbon glucose into two 3 carbon molecules of lactic acid. The final thermodynamic energy calorie release is 456,000 calories per gram molecule of energy. This dramatic difference provides good clinical correlation with the dramatic improvement in countering the severe exhaustive fatigue characteristic of cancer. Particularly, end-stage cancer, confirmed clinically by patients' experiencing a normalcy of energy level noted in 24 to 48 hours, after therapeutic subject composition of matter, with the use of hydrophilic surfactant, such as egg yolk phospholipid was administered intravenously. Note: this exhaustive fatigue adds to the depression associated with the prognosis of the disease and it represents the vicious cycle of loss of hope, that in my experience as a clinician, a patient that has a serious disease cannot afford to face. Whereas knowing that they have a very serious disease and that we are doing our utmost to reverse the disease and the symptomology helps in experiencing the removal of this exhaustive fatigue, and provides hope for the patient. There is no way to be completely certain about duration of life, or the time of death in health, or disease. This thermodynamic accounting system of energy utilization was devoted to comparison of the anaerobic prokaryotic cell with the eukaryotic cell found in mammalian and human tissue (see Peil supra).) There was no reference to cancer. This thermodynamic accounting system reference to cancer is novel to the prior art. The microbiologist, Nobel Laureate, Warburg, had observed that the cancer cell was anaerobic as anaerobic micro-organisms and inefficiently derive less than 10% of their energy from the energy sources of food. He further concluded that this anaerobic state was irreversible as in the case with microorganisms. Therefore these clinical findings of subject composition therapeutic reversibility of exhaustive fatigue are believed to be novel to the prior art. (See Piel, Gerard. The Age of Science. Basic Books 2001 New York, NY. Pages 285-286.)

This is based on the analog cell models of anaerobic bacteria and the anaerobic metabolism of the cancer cell discovered more than 50 years ago by an eminent microbiologist, Warburg (Nobel laureate for this work). At that time, it was thought to be irreversible.

It is certain that the scheme, which is valid for bacteria, is insufficient to explain the regulation of genetic activity in more complex cells or organisms. First of all, the nucleus of the bacteria is of the "prokaryotic" type: this means that it is extremely simplified. It is made of a circular thread of DNA, the bacterial chromosome, which is not surrounded by any membrane (a.) as in the cancer cell; (b.) as in the metabolically sleeping egg after maturation with lipid progesterone activation on the cell surface (no activation when lipid progesterone is injected into the cytoplasmic sap).

In view of the foregoing, it is very tempting to utilize analog to anti-bacterial technology analog to anticancer therapy as chemotherapy with induction of necrosis and apoptosis in accord with today's anticancer advances without the ability to discriminate between the healthy cells and the cancer cells except for surgery in early stage cancer.

On the other hand, the nucleus of the metabolically aerobic eukaryotes as are the normal human and other mammalian cells are. These human and other mammalian cells (in contrast to anaerobic cancer cells and bacteria) are normally surrounded by a nuclear membrane or envelope. They further contain RNA-rich nucleoli and its DNA is associated with many different kinds of histone proteins to form the chromatin that is in a loose active non-condensed foπn. Molecules at the nucleocytoplasmic border (absent in cancer cells) where a selection between mRNA which will function as messengers in the cytoplasm and others which will be retained and degraded in the nucleus occurs. Normal templating of amino acids is specified by the genetic code and function as an organizational matrix for protein synthesis. Normal templating and activation of protein synthesis is also associated with cell differentiation. (In contrast to cancer cells and tissue where protein synthesis and differentiation are arrested in cancer in view of the dense DNA chromatin "stuck" in mitosis without being able to normally precede to phospholipid activation of apoptosis as in programmed cell death.)

This is similar and analog to the metabolically sleeping egg but actively engaged in meiosis analogue to mitosis with the same characteristic features of condensed non- templating DNA chromatin, absent nucleolus the source of messenger RNA, absence of nuclear membrane and nucleocytoplasmic border necessary for selective messenger RNA activation and templating.

Whereas the fertilized egg by the sperm (the embryonic stem cell) which releases phospholipase which enzymatically releases one fatty acid molecule which makes normal organizational phospholipid even more hydrophilic and within minutes the DNA chromatin becomes functional and templates RNA and amino acid specified by the genetic code polymerization of protein. Thereby, the meiotic characteristics of the dense DNA chromatin, absent nucleolus and absent nuclear membrane are reversed through the hydrophilic surfactant activity of phospholipid to loose active DNA chromatin functional in templating amino acids specified by the genetic code polymerization and protein synthesis essential for normal embryogenesis.

The endodermal cells lining the surface of the gastrointestinal tract and the leukocytes have a cell life of two to six days (without the cancer phenomena of being stuck in mitosis). Their programmed cell death apoptosis proceeds adjacent to normal cells. This effect is very similar to what was observed in the 70 in vitro studies where hydrophilic surfactant such as bilamellar phospholipid of the normal organizational matrix of the cytoplasm, nucleus and nucleolus in cancer cell death which is now believed to be phospholipid hydrophilic surfactant activation of caspases and programmed cell death apoptosis that can occur adjacent to normal cells as such exemplified by the G.I. tract and leukocytes which have a cell life and therefore normal apoptotic programmed cell death of two to six days.

The main factors involved in nucleosome DNA chromatin assembly are the enzyme DNA-topo-isomerase I, and the karyophilic protein nucleoplasmin; both are abundant in the oocyte nucleus. It seems that the DNA molecules are first loose active and noncondensed additionally mediated by the enzyme topo-isom erase I which has all enzymes are activated by hydrophilic phospholipids.

In contrast and in preparation for meiosis and mitosis, it is believed the role of the nucleoplasmin would be to render the nucleosomes insoluble and therefore rendered templating inactive in the nuclear sap environment required for mitosis in all somatic cells or meiosis prior to fertilization in the egg and the sperm.

Analysis of maturation in sea life (Xenopus, experimental test tube of the molecular embryologist Brachet's text of Molecular Embryology) oocytes has led to the discovery of several biological "factors" of still unknown chemical nature. The most important is the "maturation promoting factor" (MPF): injection of cytoplasm, taken from a progesterone- treated oocyte a few hours before GVBD, (oocyte nucleus) into a normal recipient oocyte induces GVBD (egg nuclear breakdown) within 1 to 2 hours (maturation initially occurs after lipid progesterone stimulation of the immature egg membrane). The factor responsible for the induction of GVBD resulting in (1.) breakdown of the nuclear membrane, (2.) condensation of the chromosomes, (3.) disappearance of the nucleoli has been called MPF (maturation promoting factor, a factor found in the cytoplasm after lipid progesterone surface of maturation of the oocyte).

However, when it is impossible therapeutically to separate cancer cells from normal cells after the cancer has spread, the use of the hydrophilic bilamellar phospholipid surfactant activity with an HLB of about 8 to 10 and surfactant packing parameter mathematical formulation of ½ to 1, with a microscopic appearance of a milky colloidal emulsion dispersion of particles has been found useful in the 71 in vitro anticancer therapeutics studies to kill the cancer cells mediated by apoptosis. This is even more apparent using much lower concentrations of highly hydrophilic surfactants which have a macroscopic character of a clear solution and an HLB of about to 13 to 20 and even 20+ and a surfactant packing parameter of V/al less than ½. This includes such surfactants as the synthetic surfactants Tween 80 (polysorbate 80) and sodium lauryl sulfate (Cholase.) which corresponds to the microscopic colloidal emulsion micelle configuration of hexagonal phase, where hydrophilic water molecules surround hexagonally, the lipophilic fatty acid/fat molecules.

This is all in contrast with the reversed diagonal microscopic micelle appearance that is microscopically analog to the characteristic cell of cancer. Macroscopically, there are lumps of emulsifϊer in equilibrium with surplus of water. These coalescence are analog to the tumor like formation not seen in the foregoing lumps of lipophilic emulsifier with HLB of about less than 6; and surfactant parameter V/al of greater than 1.

It has been shown here that subject opposition therapeutics has provided hydrophilic surfactant activity that contributes to reversal of diseases of poor and guarded prognosis now includes cancer supported by the associated pharmacologic mechanisms of disease reversal provided by the foregoing data included in 70 in vitro studies and associated in vivo short- term and long-term clinical studies. Recognizing the deficiencies that predisposed to diseases such as deficiencies in biamellar phospholipid such as phosphatidyl choline are included in the strategy of new drug discovery and subject composition therapeutics enhancement of disease reversal that include cancer. Adhering to the normal HLB balance is analog to adhering in therapeutics to normal pH acid-base balance. This can be tracked clinically very simply by the use of equipment dependent upon the electrical conduction and conductance of water representing the hydrophilic component and resistance to electrical conductivity representing the lipophilic component of body tissue by the use of readily available scales such as that may by Tanita. This is further by HLB balance in our diets inclusive of adequate phospholipid phosphatidyl choline as included in therapeutics subject composition to prevent deficiency induced predispositions. Biologic competition for absorption of these lipids has been provided in the phytosterols of subject composition such as Beta sitosterol and are provided as phytosterones such as tree and plant derived resins such as gugulipids and available at Nature's Plus, Amityville, New York with a dosage of 500 to 750 mg daily to be incorporated in therapeutics subject composition.

In addition to diet, exercise has the ability in 15 minutes to counter and turn off lactic acid accumulation associated with the temporary reestablishment of aerobic metabolism known as a second wind routinely experienced by cross-country running sports. As seen above useful in adding to the reversal of diseases of poor and guarded prognosis. A therapeutic opportunity is posed here in Parkinson's disease with normalization in animal pre-clinical studies. Comparative new inventive studies with in-vivo proposed instrumentation with MRI to detect correctable deficiencies and to incorporate into inventive therapeutics treatment of neurodegenerative diseases with the further potential of MS and Alzheimer's.

(14.) Most importantly, this application technology is directed to non-invasive anticancer therapeutics. The cell biology model in cancer is based on a molecular embryologic model. This was chosen to activate and normalize human or mammalian stem cells through the cell biology model of molecular embryology. (1.) In tracing the cell biology defects of cancer, through this molecular embryology model, it was found that the cancer cell and tissue histopathologically is believed to have dedifferentiated to this earliest cleavage stage associated with first 10 hours of life's highest proliferation and high mitotic index "early" "cleavage" cell cycle from the fertilized egg to the blastula stage. (2.) Additionally, the dedifferentiation time in molecular embryogenesis corresponded to the pre-implantation time of the embryogenetic developmental stage, in which the embryonic cell mass is finally implanted in the uterus (3.) Implantation requires the development of the placenta, which in turn is required by the blastula for implantation. (4.) The placenta which is derived at the same as the requirements for blastula implantation time, from the extra embryonic cell mass simultaneously corresponds with the requirements of the blastula for implantation. (5.) This dedifferentiation occurred, it is believed, at the crossroads of the blastula implantation into the placenta. However, it must be emphasized that the maternal uterine chorionic villae play a structural role in receiving the implant extra embryonic cell mass. Some of the placental tissue and protein biochemistry is derived from the uterus and therefore may be in common with normal human tissue. However, after delivery of the baby, the after birth placental tissue is spontaneously removed from the uterine wall. This after birth is associated with blood loss during placental detachment. Therefore, it is likely that all the placental tissue has been completely removed. It is believed that further studies will confirm the belief that this placental protein appears to be unique to cancer tissue and its dedifferentiation.

In contrast, it is therapeutically important to note the sources since we have found that the amnion is derived from the embryonic cell mass.

It is important to stress these different origins in these therapeutic applications such as regeneration of tissue. Therefore, the equine amnion was used in conjunction with subject composition lotion to successfully re-grow skin in equine veterinary care in one of the 25 successful therapeutic subject composition disease reversals as cited here in the equine veterinary case examples.

In addition to this anticancer effect, it is believed that this could act as an anticancer vaccine adjuvant. It is reasonable in using the molecular embryologic cell model, and discovering crossroads of dedifferentiation, we have also discovered a source of protein chemistry that is not present in human tissue. This protein-chemistry source has extra embryologic presence detected by dedifferentiation through cell model biology precursor. The logical consequence of this pursuit has been shown in cancer to be a protein antigen present in the placenta. In so doing a protein antigen, human aspartoaspergillin, hydroxylate enzyme (HAAH) that hydroxylates growth factor EGF domain signaling was found. HAAH is specifically expressed on the surface of all malignant cells and phenotypes of cancer cells. Neutralizing or inhibiting the cell-surface HAAH reverses cancer cells to normal phenotype. HAAH is a true cancer marker with specificity and sensitivity of more than 90%, and passive immunotherapy has been effective in cell and animal models. It is believed this abnormal protein present in cancer is amenable in providing immunologic anticancer vaccine protection. (Hossein A. Ghanbari, Cambridge Healthtech Institute program abstracts, Immunotherapeutics & Vaccine Summit, Cambridge, MA Aug 14, 2008) This would be an appropriate cancer vaccine protein to adapt this subject composition of matter as synergistic adjuvant vaccine therapeutics.

Another study that was done and reported illustrates a method to determine abnormal proteins in cancer. "Bracket 's text of Molecular Embryology (Verlag, New York 1986, chapter 4, page 58 performed by Gurdon) The nucleus from human cancer cells, donated to science by Helen Lane referred to as HeIa cells, were injected to sea life egg cytoplasm. Again emphasizing the inventive therapeutics in disease resolution, the therapeutic potency of tissue particularly the replication of embryonic tissue. When they analyzed the new synthesized proteins, it was found that only 3 (of 25) were synthesized by the transplanted nuclei. Therefore, the egg cytoplasm of the sea life (Xenopus) has the remarkable property of re-programming the expression of the individual HeIa cell genes. This might be a useful experiment in discriminating abnormal proteins in cancer, versus normal tissue proteins, as selected by the sea life egg. The embryonic and pre-embryonic phase of life is remarkably resistant to cancer. (Gurdon JB 1981 Xenopus oocytes. Nature, London). In Gurdon' s additional work on the controls exerted by the cytoplasm in nuclear activities, a fit for hydrophilic surfactant therapeutics becomes evident in the management of cancer where the therapeutic goal of normalization of nuclear DNA chromatin function would be desirable use of synthetic replication of tissue obviates the risk of embryonic stem tissue to dedifferentiate to cancer particularly in a cancer prone patient This is demonstrated therapeutically by the 71 in-vitro examples of studying these effects in induction of apoptosis; believed to be associated with the metabolic, enzymatic activation as required in cancer. He first injected into the sea life (Xenopus) adult brain nuclei into the cytoplasm of sea life (Xenopus) oocytes and eggs and obtained the following results: If brain nuclei are injected into full-grown oocytes, they swell (an index of hydrophilic hydration and metabolic enzymatic activity) and synthesize RNA. However, if they are injected into oocytes undergoing maturation, their chromatin condenses and they may even form chromosomes and mitotic spindles. They no longer synthesize RNA, in view of the characteristic features of mitosis, the absence of the nucleolus, the absence of the nuclear membrane (the naturally present phospholipid surfactant organizational membrane essence of nuclear membrane, and its phospholipid surfactant) (J. Brachet H. Alexandre, Introduction to Molecular Embryology, Springer- Verlag 1986, including p.94). This quote is applicable to the energy derived as shown in Leonard S. Girsh, M.D., Lipid Containing Compositions and Methods of Using Them, US patent 2007/0037777 Al, Feb.15, 2007 and details pertinent to energy production exemplified by anaerobic energy occurring at the end of mitosis and mutagenic diseases such as cancer. This is in contrast to the energy production in disease resolution and resultant normalization and associated aerobic metabolism. (Piel, Gerard. The Age of Science. Basic Books 2001 New York, NY. Pages 285-286 is hereby incorporated herein in its entirety). Title: Surfactant ratios and formulations in selectivity in normalization of cancer cell biology & therapeutic response. Introduction

This anticancer therapy discovery began with the recognition of the remarkable analog similarity of the 3-D configuration of a metastasized breast cancer cell and the lipophilic reversed hexagonal configuration of the micelle of an emulsion. We find here that this is the only surfactant category with macroscopic appearance of lumps of emulsifier in equilibrium with surplus of water, further analog to the lump-like onset of cancer. Also, the following associated surfactant parameters are representative of this cancer anomaly in that this is the only surfactant category with a hydrophilic lipophilic balance

(HLB) mathematical ratio of 6 or less, and surfactant packing parameter greater than one. Description:

(1.) In- vivo and in-vitro studies indicate that detergent surfactants can reduce the growth rate of cancer and improve the feeling of well being of the patient.

(a.) In 24 to 48 hours, 10 in-vitro studies showed an excess of 88% cancer tissue lethality. 3 studies showed 99 to 100% cancer tissue lethality.

Concentration of surfactant required to achieve these results were proportionate to degree of surfactant hydrophilicity, measured by hydrophilic lipophilic balance mathematical ratio.

(b.) In view of this success and safety, this treatment was also used in- vivo for end stage cancer patients. Therapy was given intravenously every other day for 7-10 days in treating various types of cancer. Within 24-hours all patients experienced dramatic improvement in energy and sense of well- being. One patient had a superficial palpable anal cancer lesion which was observed to be reduced by 40% in approx 7 days. This anticancer composition is comprised of at least one surfactant wherein the total concentration of surfactant can reduce or eliminate symptoms of disease. This FDA pre-approved-as-sqfe composition using Generally Recognized as Safe (GRAS) components (in accordance with the code of Federal Regulations, 21) can be administered orally or intravenously to patients with end-stage cancer who suffer from the ravages of disease itself and long term treatment regimes.

(2.) Two major components of surfactants have been successfully tested. (a.) Non-lipophilic bilamellar geometric configuration of phospholipid cell membrane surfactants with HLB ratio greater than 8 to 10 and a formula derived surfactant packing parameter of ½ to 1, derived from the formula v/al. V and I = volume and length of the hydrocarbon chains (hydrophobic) a= effective area of the hydrophilic polar group. (This effective area depends on both the actual size of this polar group and forces acting between these groups within the micelle).

(b.) Non-lipophilic surfactant category with hexagonal geometric configuration and HLB greater than 13 and surfactant packing parameter of ½ or less. 3. The concentration of surfactant required to achieve these results were inversely proportionate to the degree of surfactant hydrophilicity, measured by hydrophilic lipophilic balance mathematical ratio and directly proportionate to surfactant packing parameter number.

4. With all in-vivo studies, there were no adverse side effects. 5. Mechanism of action: This anticancer therapy is targeted to counter the 3-d micelle configuration of the abnormal mitosis of cancer:

(a.) As this detailed histopathologic further study of abnormalities in mitosis characteristic of cancer are continued with finding dense nuclear DNA chromatin of cancer to be in a nonfunctional gridlock of density. This is in contrast to the normal loose functional network of normal nuclear DNA chromatin. This dense nuclear DNA chromatin has therefore lost its ability to normally template protein synthesis through the progressive steps of DNA, RNA utilization of amino acids, in finalizing the polymerization process of templating protein synthesis.

(b.) These hydrophilic and bilamellar surfactants counter lumps with surplus of water. (Diagram 1, figure 1 of emulsion technology Kare Larsson, Stig E. Freigbur, Food Emulsions. Potsdam, New York, page 64).

(c.) Re-suspending and normalizing the dense cancer cell nuclear DNA chromatin into a fluid functional phase, permits the cell to proceed to apoptosis by normally templating the required enzymes such as caspase.

This reversal to normal is therapeutically achieved by the hydrophilic and bilamellar surfactants respectively.

(d.) Respiratory enzymatic proteins under control of DNA chromatin are enabled to go to a more efficient phase at the mitochondrial level.

(e.) Therapeutic introduction of cell membrane phospholipid bilamellar surfactants has been associated with normalizing nuclear membrane anaerobic analog to prokaryocyte existence of the cancer cells. It is believed that this peπnits normalization of human mitosis, with its associated normal aerobic respiratory enzymatic protein. This prolonged nuclear membrane free anaerobic analog to prokaryocytic existence in cancer is rarely seen in normal tissue. This now becomes associated with normal aerobic enzymatic protein at the mitochondrial level.

(f.) The foregoing observations also offer the opportunity to normalize another discovered clinical con-elation in cancer. Long-term patient care with a predisposition to excessive morbidity and mortality related to the decubitus ulcer pressure sore is further correlated with an abnormally low serum albumin protein level.

(g.) Further mechanisms: This emulsified bilamellar phospholipid surfactant with its hydrophilic lipophilic HLB mathematical ratio of about 8 to 10 in contrast to an estimated HLB of six or less in cancer and surfactant packing parameter of 1/2 to 1 offers therapeutic ability to correct the abnormal colloidal emulsion of six or less which it is believed with the evidence presented characterizes cancer.

These forces and effects are possible because of the unique hydrogen bonding that hydrophilic surfactant entrapping of structured water provides along with electrostatic and Van der Waal forces therapeutically augmented in the presence of these bilamellar, hydrophilic surfactants.

Conclusion: By providing more hydrophilic surfactants with biochemical and biophysical parameters, obverse to cancer, offered here is an effective, safe opportunity for in-vitro, and in-vivo therapeutic anticancer selectivity. Not only is this applicable for adults, but also for children, where self image and innate immunity are so important. It provides an unparalleled safety that does not interfere with growth and development.

It is believed to be possible that the crystalline asbestos body that is not part of a colloidal or emulsion system may also mediate its carcinogenesis through a mitotic proliferation effect in a similar proposed fashion. A very similar hydrophilic surfactant approach brings about an increase in hydrophilicity starting with the phospholipid phosphatidyl choline. Therefore, subject composition therapeutics may also be utilized in preventing, or actively treating the carcinogenesis associated with asbestosis. These anticancer organizational matrices tested in 14 of the 70 in-vitro examples presented here have shown an efficacy of 73% to 99-100%. When one also includes the subject composition therapeutic opportunity for noπnalization of apoptosis and its associated metabolic enzymatic dissolution of cancer tissue, this therapeutic advance is believed to be very significant, considering cancer being a disease of poor or guarded prognosis. Additionally, since embryogenesis is closely associated with healing, the embryogenetic apoptosis that shapes our fingers in utero seems here to be analog to a preliminary biochemical biorobotic surgical technology, as the net effect of this first therapeutic approach or may be reserved for end-stage anti-cancer therapeutics. An anticancer therapeutics is provided here by the normalization of hydrophilicity of two cell cycles, not only the apoptotic metabolic enzymatic cell cycle; but also normalizing the associated most highly proliferative early cleavage cell cycle.

The foregoing builds upon the microscopic lipophilic micelle, being analog to the microscopic characteristic cell of cancer. This also provides evidence that this inventive finding may be used successfully therapeutically in treating cancer with this subject therapeutic composition of matter. Therapeutic success that can be seen through these working analog biologic models provides a new safe anticancer therapeutics without limitation of the type of cancer, since it is based on the characteristic cell of all cancers. This includes further corroborative studies that are believed to provide basis for anti cancer drug discovery and testing. This includes testing the acceleration of germination time of plant seeds such as grass seeds.

Specific to anti cancer treatment, novel to the prior art, we find further corroboration that dismembering phospholipid, phosphatidyl choline results in animal experiments of progressive 6 months of inflammatory hepatitis without any evidence of a viral cause. This progressively severe inflammatory hepatitis is followed by 6 months of progressively severe hepatic cancer and death of the animal from cancer. It is believed by removing the choline (depleting the animal of the choline), the animal is left with the lipophilic micelle depicted above and believed to be representative of the "cancer molecule". The lipophilicity as measured by HLB, is less than 6. This illustrates that the "cancer molecule" is causing a dual dysfunction in impairing fat metabolism and explaining, in a sense, a type of cancer dependent upon an imposition of disturbed function rather than what has heretofore been stressed as a type of cancer. The associated parameters of this geometric morphology are further supported by the corresponding macroscopic appearance parameter seen on diagram 1, figure 1, lumps of emulsion in equilibrium with surplus of water which is suggestive of the onset of tumor mass. Importantly, this macroscopic appearance emphasizes the disruption of the emulsion state of charged particles in equilibrium with trapped water. It is believed that these particulates are in keeping with the crystalline features of mitosis in contrast to the enzymatic metabolic phase of the cell cycle. However, nothing here or in any other prior art, presents the therapeutic subject composition and its components as an anticancer treatment.

Also, it is not surprising that the cancer with the dismembered choline depleted phospholipid involves the liver, since the phosphatidyl choline are particularly important in the metabolism of the fats by the liver. (G. Sackheim and R. Schultz, Chemistry For The Health Sciences 3^rd ed. Macmillian, 1977 page 295). It is further believed through the unexpected findings of reviewing the progression of bio molecular molecules are deviants of normal, such as a lipophilic micelle and its analog characteristic cell of cancer, the abnormal misfolding of the normal nuero protective protein prion (PRPc) mad cow disease (PRPsc). Normal folding seems to be dependent on the variant of the primary proteins, moiety of the random coil (that appears on the diagram of the normal prion analog to a "pony tail", (or string of beads) that folds with beta sheets that look more like barrel staves. This is in contrast to HLB of L amino acids, and glycine specified by the genetic code, and on associated hydrophilic HLB factors. (Kinsella's text book, Protein Structure Of Foods, section on protein folding related to comparative HLB of amino acids). This lipophilic micelle analog to the characteristic cell of cancer and the abnormal misfolded prion protein of mad cow disease both have commonalities: the ability to mediate diseases of poor prognosis, cancer and mad cow disease respectively. The potential ability is believed to be reversible to normal with exposure to hydrophilic polar surface active lipids, as well as the ability to self replicate like nylon polymerization. This self replication is not dependent on the presence of nucleic acid or viruses.

It is believed that the pathogenic molecules, abnormal lipophilic liquid crystal micelles, and abnormally folded prions present the potential for "infectivity" like a live organism. Analog in this regard to Koch's postulates (cited below) and reversibility with highly hydrophilic surfactants, utilizing this therapeutics subject compositions, and is unique in these respects to the prior art.

Humans can become depleted of choline and develop liver damage when fed purified diets or when fed parenterally with low-chlorine formulations. In choline-deficient rats there is enhanced hepatocyte cell death, compensatory increases in hepatocyte DNA synthesis, and liver regeneration. After 6 months on a choline-deficient diet, foci of preneoplastic. hepatocytes appear in rat liver, and hepatocellular carcinomas occur at approximately 12 months, despite the absence of any known carcinogens. The mechanism for the cancer- promoting effect of choline deficiency is not completely elucidated. Perturbations in important intracellular signaling mechanisms regulate cell growth involving hepatic 1, 2-sn- diacylglycerol concentration and protein kinase C (PKC) activity occur in choline deficiency. The chronic cell death and cell proliferation in choline-deficient liver, with its associated increased rate of DNA synthesis, could cause greater sensitivity to chemical carcinogens. Alterations in the genome that occur in choline deficiency, such as hypomethylation of DNA and DNA damage caused by free radicals, also probably enhance carcinogenesis. We add to this list of mechanisms the possibility that loss of an apoptosis pathway contributes to carcinogenesis in the liver of choline-deficient rats (B. F. Szuhaj,and S. H. Zeisel, ''Choline, Phospholipids, Health, and Disease" SOCS Press, page 16 along with cited references 86-98 on pages 21 & 22). This subject composition anticancer treatment includes hydrophilic surfactants such as, phospholipid, such as phosphatidyl choline, to also include choline and inositol 250 mg each, (as used in the hearing loss example).

As we have indicated, this also permits for the expansion of the treatment of other diseases through the use of subject composition polar surface active features; not only of more hydrophilic components of subject composition including, such as, but not limited to, phospholipids and phosphatidyl choline. This further includes amino acids and extra- cellular matrix components that additionally have hydrophilic activity of therapeutic subject composition of matter that we have to date innovatively added to anticancer therapy. This is in addition to the initial observations exemplified by the ratio of lecithins to sphingomyelin sloughed off by an infant into the amniotic fluid may be used as a test for hyaline membrane disease. A ratio of more than 1.5 to 1 indicates that the infant's lungs have developed sufficiently. If less than that ratio, subject composition will be therapeutically increase. In hydrophilicity increase, with the use of polar surface active lipids such as phospholipid phosphatidyl choline, is believed to be a therapeutic approach actively and preventively in the premature infant with hyaline membrane disease. Here, the mother is destined to have a premature delivery. This is particularly applicable since oxygen that we depend upon for survival is lipid soluble and this would normalize the membrane and enhance oxygen transmission much needed in these potential premature infants with potential hyaline membrane disease. This enhancement of transmission of oxygen is therefore affective in treating diseases with potential hypoxia, such as coronary artery disease, with the added advantage of a 25% increase in blood flow. The increase in blood flow is due to enhanced elasticity of the red blood cell membrane facilitating the passage, and thereby oxygenating these small channeled blood vessels and capillaries when used in dosages of 1.8 grams daily, for 30 days of phosphatidyl choline (B. F. Szuhaj, "Lecithins Sources", manufactures and usages, page 249) (G. Sackheim and R. Schultz, "Chemistry For The Health Sciences" 3^rd ed. Macmillian, 1977 page 295).

The biochemistry of cleavage and the chemical nature of the mitotic cleavage and organizational apparatus (MOTC). (See Figure 6) The mitotic apparatus comprises the spindle, the chromosomes, the centrioles and the two asters. Mazia and Dan succeeded in isolating the whole, intact mitotic apparatus from cleaving sea urchin eggs. Mitotic apparatus is made of a variety of proteins; the major one is tubulin. Tubulin is a globular molecule made of 2 non identical subunits, and undergoes linear polymerization. In-vitro tubulin polymerization is enhanced by addition of other proteins, the microtubule-associated proteins (MAPs). In the living dividing cell, microtubule polymerization starts from organizing centers (MTOCs), which act like seeds in the growth of crystals. The main MTOCs are Centrioles, (pericentriolar clouds that diffusely surround centrioles), and the kinetochores (centromeres) of the chromosomes. It is believed that polymerization of tubulin starts at these 2 MTOCs and that it progresses by "treadmilling". New ubulin molecules are added at the end of the growing microtubules; others are lost at the opposite end. At anaphase, depolymerization of the microtubules takes place in the central region of the spindle. The dynamics of cell division remain poorly understood. Some believe that anaphase movement of the chromosomes results from an ATP- driven sliding of the microtubles, which would shorten the half spindles. ATP-dependent contraction would draw the kinetochores, and then the whole chromosomes toward the poles. Still, others propose that anaphase chromosome movement is due to a Ca2+ induced depolymerization of the microtubules, starting at the spindle's equator and progressing toward the poles. Several molecular mechanisms might of course cooperate in chromosome separation and movement (J. Brachet H. Alexandre, Introduction to Molecular Embryology, Springer- Verlag 1986, page 94).

Particularly important and interesting are the enzymes which exert a regulatory role in the cell metabolism. For example, adenylate cyclase and guanylate cyclase, 2 membrane- bound enzymes, control the intracellular content of 2 cyclic nucleotides, cAMP and cGMP. In general, a high cAMP content inhibits cell division and favors cell differentiation and therefore, anticancer effect. This is a very favorable anticancer therapeutic pharmacologic mechanism that can be tracked in subject composition; position in the adaptation cGMP has the opposite effects. There is currently a great deal of interest in the protein kinases, which transfer phosphate from ATP to an acceptor protein. Protein phosphorylation modifies the spatial structure and the electrical charge of the protein. Protein kinases, as a rule, require cAMP, cGMP or calcium ion and phospholipid, as an essential component of subject compositions anticancer therapeutic effect for activity.

The foregoing cyclic AMP has been classified as a second messenger in the G protein important pharmacologic system as a basis for advancing new drug discoveries. These include receptors as enzyme: receptor protein kinases. A modified protein kinase receptor includes several receptors for neurotrophic peptides and the multi subunit antigen receptors on T and B lymphocytes. Receptors with other enzymatic activities are included in the receptor domain structures. The receptors for atrialnatriuretic peptides, and the peptide guanylin, the intracellular domain, not a protein kinase, but guanylyl cylclase synthesize the second messenger cyclic GMP. Ion channel receptors for several neurotransmitters form agonist to regulative ion selective channels in the plasma membrane, termed lygand/gated ion channels, which convey their signals by altering their cell membranes potential or ionic composition. This includes nicotinic cholinergic receptor, the GABA receptor for GAMA, amino butyric acid, and receptors for glutamate aspartate, and glycine. They cooperatively control channel openings and closings. They span the plasma membrane several times; the G protein couple receptors span the plasma membrane as a bundle of 7 alpha- helices, each with a distinctive specificity for 1 of several of a ½ dozen G proteins. Transcription factors, receptors for steroid thyroid hormones, vitamin D and the retinoid soluble DNA proteins regulate the transcription of specific genes. The cytoplasmic second messenger cyclic AMP is well studied second messenger which include cyclic AMP and cyclic GMP, calcium, ions, inositol phosphates, diacylglycerol, and nitrous oxide). (Text book of Medicine J. E Pizzornor, Churchhill Livingstone, 1999).

These cell biology models are analog to the biochemistry of the prion (the variant of the normal molecule in the mammalian or human tissue) in mediating mad cow disease. As seen here, Koch's postulate, this provides insight with regard to the cause of cancer.

Criteria for developing inventive therapeutics and instrumentation analog in this inventive therapeutics to Koch's postulates of historical significance confined to developing anti- microbial therapeutics:

1.replicating human tissue

2. tracking biomarkers of disease

3. disease resolution pos-tu-late

Koch's p's, a statement of the kind of "experimental evidence required to establish the etiologic relationship of a given microorganism to a given dissase. The conditions included are (1) the micro organism must be observed in every case of the disease; (2) it must be isolated and grown in pure culture; (3) the pure culture must, when inoculated into a susceptible animal, reproduce the disease; and (4) the πu'croorganisrn must be observed in, and recovered from, the experimentally diseased animal.

(P.) Neurologic Disease, Mad Cow Disease

Similar treatment could be used in the management of misfolded protein diseases, such as mad cow disease. This appears to be a pertinent application technology in view of the fact that primary protein folding to secondary or tertiary protein folding is highly dependent upon HLB micronutrient microenvironment. This is the case even though the arrangement of the primary string-like alignment of amino acids is genomically determined by DNA and RNA templating. However, a very important part of the biologic activity, normal or otherwise, (as in the case of mad cow disease) is dependent on the 3-D final folding of the secondary or tertiary folding.

Mad Cow disease is transmissible to humans. The normal protein prion molecule is mis-folded. Protein folding is highly dependent upon hydrophilicity, and HLB balance, as illustrated by the impact of the relative HLB of amino acids as shown in prior reference tables. It is note worthy that this random coil of the molecule has the biochemical configuration of a 'tail'. When transformed to Beta sheets, the random coil looks morphologically like staves that compose strips in a barrel. Another analog to this biochemical comparative model of a disfigured normal chemical molecule, such as a protein that is analog to the observations we made regarding the foregoing biologic model, is the fact that this modification makes this disease prion molecule isoform. This is referred to as prion scrapey PRsc, also resistant to enzymatic digestion by proteinase K (Pk). The remarkable similarities here are the resistance to enzymatic digestion and molecular configuration of protein that is dependent upon hydrophilic/lipophilic balance (HLB). This brings on a change in function primarily because of a change in the 3-D structure. These 3-D interfacial fits determine the efficacy of the enzyme such as, but not limited to, caspase, interacting with the substrate.

A most significant basis of this invention is the 3-D distinction of the chiral in contrast to the D- amino acids stereo chemical configuration of the L-amino acids specified by the genetic code. (See Figure 7A and Figure 7B. ). Use of therapeutic subject composition in the multiple Enzyme Deficiency Diseases such as, but not limited, to Gaucher's Disease. Gaucher's Disease is an enzyme deficiency lipidosis disease associated with similar lipophilic micelle (as discussed in cancer), where in these lipophilic micelle bodies can be seen as abundant lip-laden granular cytoplasm. Illustration of the biologic activity of a protein enzyme which is dependent on secondary and tertiary folding associated with hydrophilicity HLB. Also, the protein enzymatic catalytic effect upon substrate can also be enhanced by increasing HLB associated amniotic charge and a more intimate interfacial associative interaction. This can be looked upon as catalyzing the protein enzyme catalyst. The BPTI molecule (top) fits snuggly onto the surface of the trypsin molecule (bottom), blocking the active site of trypsin. This figure is from a computer "docking" simulation, which closely (within 0.05 mm) matches the x-ray structure of the complex. (See Figure 8) This subject composition treatment with the use of FDA pre-approved-as-safe biochemical components that mimic human tissue and human tissue's healing capacity can be readily tested with in- vitro, and in-vivo studies as in the case of foregoing examples.

(Q.) Neurologic Disease in the elderly illustrated by Parkinsonism, Alzheimer's, and hearing loss (neuro-sensory)

The appropriate therapeutic subject composition can be applied in neurologic and neuropsychiatric diseases. This therapeutic potential is augmented with this amino acid containing subject therapeutic composition; for example, advancing the treatment of Parkinsonism with an L-phenylalanine derivative lcvo dopa. This same therapeutic potential additionally offered by these aromatic amino acids, such as L tryptophan, augments advances in other neurotransmitter neuro-therapeutics are required with the advantageous use, as a relaxant tranquilizer, in view of the soporific effect of L tryptophan. The L amino acid glycine, such as the aromatic amino acids L tryptophan, mentioned above, and L tyrosine and L phenyalanine, components of subject composition, advances the treatment of diseases of poor or guarded prognosis potential. This comprises disease such as schizophrenia, Alzheimer's disease, and hearing loss, associated with the neuro catabolic factors of aging.

The aromatic amino acids, tryptophan and tyrosine, produce the neurotransmitter amine serotonin. Where as phenylalanine and tyrosine produce the neurotransmitters norepinephrine and epinephrine, as well as L DOPA (dihydroxyphenylalanine), and when decarboxylated, results in dopamine. Only L DOPA is therapeutically applicable since it can be converted to dopamine in the nervous system. Where as the 3-D stereo fit of dopamine cannot cross the blood brain barrier and enter the central nervous system.

This is also the case in the component subject composition phospholipid phosphatidyl choline. By advancing the neurotransmitter supply of acetylcholine, choline is 100,000 times more active in enhancing the supply of the missing neurotransmitter acetylcholine as in Alzheimer's disease.

Choline and Inositol have been added to therapeutic subject composition to help advance the care of neurologic and neuropsychiatric diseases. The immediate metabolic precursor of the neurotransmitter, Dopamine, is transported into the brain by the large neutral amino acid transporter, and permeates into striatal tissue, where it is decarboxylated to dopamine. Since dopamine does not cross the blood-brain barrier when administered systemically, it has no therapeutic effect in Parkinsonism. (R.) Male patient in his late 70s with congenital tremor at age 50 of such severity that he found he was unable to continue with his surgical practice of obstetrics. Family history: his mother had similar symptoms of congenital tremor. Our findings of healing and disease resolution based on replication of human tissue biochemically to repair, regenerate disease and damaged tissue that includes neurologic tissue encompasses also replacement of biochemical deficiencies. This was pioneered by the introduction of insulin to replace a deficiency in the diabetes that has with stood the test of time. However, that fact that the diabetic patient does not return to normal provides working evidence that there are probably other associated deficiencies and therapeutically amendable to subject composition. We have shown this direction of advancing therapeutics is applicable in a disease system of neurologic disease as well as in other disease systems. In fact every disease system that we have explored in this fashion has revealed similar confirmatory findings such as the 7,000 articles on the treatment of cancer based on resolving tissue deficiencies. A recent study from Taiwan showed that a breast biopsy confirming cancer was also deficiency in the micronutrient selenium whereas normal adjacent tissue free of cancer was also free of selenium deficiency confirming the thesis of the value of tracking and treating the biochemical inadequacies of disease cell lines and thereby providing healing and disease resolution. This is confirmed by findings such as these provide support for healing using treatment biochemical adequacies to reverse the disease cell line deficiencies. This offers us further confirmation of our original thesis of providing healing by mimicking human tissue biochemically of 6,974,796 Bl . These observations were further based upon our research of human and animal model responses with the bio-material component composition of the subject and related ϊmmunotherapeutics in regard to reversal of neurologic disease. These components include micronutrient vitamin deficiencies such as E, Bl, A, amino acid deficiency, and homocysteine metabolic deviant resulting in a deficient supply of the essential amino acids methionine and cysteine because if lack of vitamins B₁₂, folic acid, including methyltetrahydrofolate B6 resulting in a lack of methylation of demethylated methionine. Deficiency in cell membrane component, omega 3 fish oil, extracellular matrix deficiency composition of 6,975,796 Bl and in accord with composition tabulated in the 2004 declaration to PTO. (Carlson Vitamins, Super 2 Daily vitamin and mineral soft gel, Arlington Heights, IL). Selenium was tracked in the therapy of burns in a report by Bergcr in 2007 showing that in 20 days the tissue integrity of selenium and its protein enzyme composition was normalized whereas in ten days the activation of anabolic protein synthesis tracked by tagged amino acids was observed (analog to the molecular embryology of activation of protein synthesis in the sleeping egg when tracked within a few minutes of fertilization).

Wound Healing and Tissue Repair in Adults

Trace element supplementation after major burns increases burned skin trace element concentrations and modulates local protein metabolism but not whole-body substrate metabolism.

BACKGROUND: After major bums, patients exhibit an intense catabolism, and the wounds often require surgery and grafting for closure. Complications, such as weight loss and delayed wound healing, are worsened by trace element (TE) deficiencies. OBJECTIVE: We aimed to assess the effects of TE supplements on systemic substrate turnover and local protein metabolism during wound healing after major burns. DESIGN: This was a prospective, randomized, placebo-controlled trial in 21 patients aged 35 +/- 11 y with burns on 45 +/- 16% of their body surface area; 12 had skin biopsies performed on days 3, 10, and 20, and 10 patients underwent a stable-isotope investigation on day 10. Intravenous copper, selenium, and zinc (TE group) or vehicle (V group) was given with a saline solution for 14-21 d. On day 10, [(13)C]phenylalanine (600-mug/kg bolus followed by 12 mug . kg(-l) . min(-l)) plus 6-[(2)H(2)]glucose and [(2)H(5)]glycerol were infused for 6 hrs. to determine skin protein turnover. Biopsies were performed 1 and 6 hrs. after the start of infusion to determine [(13)C]phenylalanine enrichment.

RESULTS: The patients' mean ages and burn severity did not differ significantly between the groups or between the skin investigations subgroups. Plasma TE concentrations were significantly higher in the TE group. In the burned areas, the skin contents of selenium (P = 0.02) and zinc (P = 0.03) increased by day 20. The supernatant- to -plasma (13)C enrichment ratio in burned skin was 0.363 +/- 0.094 (TE group) and 0.286 -/- 0.130 (V group) after 1 hr. (NS) and 0.592 +/- 0.153 (TE group) and 0.262 +/- 0.171 (V group) after 6 hrs., which reflected lower catabolism in the TE group (P = 0.03). No significant differences in whole- body substrate turnover were found between the groups.

CONCLUSION: TE supplementation was associated with an increased skin tissue content of selenium and zinc and with a reduction in skin protein catabolism. Ataxia with isolated vitamin E deficiency is a rare autosomal recessive neurodegenerative disease due to mutations in the alpha-tocopherol transfer protein gene. In ataxia with isolated vitamin E deficiency, the biochemical hallmark is the low plasmatic levels of vitamin E and, in most of the patients, vitamin E supplementation allows a stabilization of the neurologic conditions. We have investigated the genetic cause of ataxia and reduced levels of vitamin E, and apolipoproteins Al and B in a 16-y-old patient. Results revealed that our propositus is a compound heterozygote for the c.227_229delinsATT/c.744delA mutations in the alpha-tocopherol transfer protein gene, each inherited from one of the two parents. His sister is also a compound heterozygote for both mutations, and she presents a biochemical pattern similar to that of his brother. After receiving the vitamin E supplementation, plasmatic levels of vitamin E and apolipoprotein Al have been normalized in the propositus. The detected mutations would justify the undetectable levels of vitamin E, but would not explain the also decreased levels of the apolipoproteins, as neither that after treatment with vitamin E, the levels of apolipoprotein B do not become normal. These findings suggest that other genes may play a role in producing this atypical biochemical profile.

Our previous studies implicated vitamin E deficiency as a risk factor for equine motor neuron disease, a possible model of human amyotrophic lateral sclerosis, and showed direct effects of this deficiency on brain vascular endothelium. To gain better understanding of the pathogenesis of equine motor neuron disease, we determined the effects of dietary antioxidant insufficiency and the resultant brain tissue oxidative stress on blood-brain barrier permeability. Rats (n = 40) were maintained on a diet deficient of vitamin E for 36 to 43 weeks; 40 controls were fed a noπnal diet. Permeability of the blood-brain barrier in the cerebral cortex was investigated using rhodamine B, and lipid peroxidation was measured as a marker for oxidative stress. Animals on the vitamin E-deficient diet showed less weight gain and had higher brain lipid peroxidation compared with the controls. Fluorometric studies demonstrated greater rhodamine B in the perivascular compartment and central nervous system parenchyma in rats on the deficient diet compared with controls. These results suggest that a deficiency in vitamin E increases brain tissue oxidative stress and impairs the integrity of the blood-brain barrier. These observations may have relevance to the pathogenesis of amyotrophic lateral sclerosis and other neurologic diseases.

Folate and vitamin B 12 deficiencies represent important and evolving global health challenges that contribute to the global burden of anemia, neurologic conditions, neurodevelopmental disorders, and birth defects. We present a review of population-based programs designed to increase consumption of folates and vitamin B 12. A folic acid supplementation program targeting couples prior to marriage in China has led to optimal consumption of supplements containing folic acid and a significant reduction of neural tube defects (NTD). Supplementation programs that use mass community education show some promise, but have not been shown to be as effective as targeted education. The success of supplementation programs hinges on a strong and persistent educational component and access to the supplements. Fortification with folic acid has been shown to reduce the prevalence of NTD in the countries where it has been implemented. Challenges to fortification programs include identifying the appropriate delivery vehicles, setting the optimal fortification level, sustaining the quality assurance of the fortification level, and addressing regulatory challenges and trade barriers of commercially fortified flours. Supplementation and fortification are cost-effective and viable approaches to reducing the burden of NTD, anemia, and other conditions resulting from folate deficiency. The experience with interventions involving folic acid could provide a model for the subsequent development of supplementation and fortification programs involving vitamin B 12

(S.) Unilateral Peripheral Neuropathy of the lower extremity following a traumatic injury of lumbo-sacral disc and complications of nerve pressure upon the innervations of the lower extremity unilaterally. These observations were further based upon our research of human and animal model responses with the bio-material component composition of immunotherapeutics of this and related applications in regard to reversal of neurologic disease. These components include micronutrient vitamin deficiencies such as E, Bl, A, amino acid deficiency, and homocysteine metabolic deviant resulting in a deficient supply of the essential amino acids methionine and cysteine because if lack of B vitamins 12, folic acid, B6 resulting in a lack of methylation of demethylated methionine. Deficiency in cell membrane component, omega 3 fish oil, extracellular matrix deficiency composition of 6,975,796 Bl . (Carlson Vitamins, Super 2 Daily vitamin and mineral soft gel, Arlington Heights, IL).(T.) Re: Hypertension Patient in 80s with symptoms of acute dizziness never noted prior, whose blood pressure readings were 160/90 and as high as 190/88 was treated with subject composition of 6,974,796 Bl comprising the following items: * grape seed extract capsule (1 capsule Ix per day, 300mg, Healthy Origins, Pittsburgh, PA.),

• olive leaf extract capsule(l capsule 3x per day, oleuropein content of 6%, 500mg 3x per day, Now Foods, Bloomingdale, IL.) (Ideally oleuropein content should be between 17-27% as available 18% oleuropein content capsule from Oregon's Wild

Harvest, Sandy, OR). Discontinued after two weeks because of slight dysarrhythmia (drop beats)

• omega 3 fatty acid fat capsule (increased to 2 capsules 3x per day. 750mg/l gram capsule (350mg cicosapentaenoic acid and 250rng docosahexaenoic acid. Carlson Laboratories, Arlington Heights, II.)

* flax oil capsule (1 capsule 2x per day, Barlean's Organic Oil, Ferndale, WA.)

The blood pressure readings improved to 120 -130 systolic over 70-80 diastolic (confirmed in both arms). The symptoms of dizziness have not recurred. With stress of blood pressure readings have occasionally increased to 140/88 which improve with a beta blocker drug, Toprol XL (25mg tablet, AstraZeneca. Wilmington, Delaware) ½ tablet daily and Benicar (20mg tablet, Olmesartan Medoxomil-Hydrochlorothiazide) 1 tablet daily to be used if the blood pressure failed to be controlled. (Benicar HCT, Daiichi Sankyo, Inc.. Parsippany, NJ. was contraindicated in that this patient has gout and an elevated uric acid level of 8% with a few percent risk of hyperuricemia. Therefore it was not recommended as a back-up therapeutic). Benicar 20mg daily (Daiichi Sankyo, Inc., Parsippany, NJ.) was added because of increases in blood pressure to 170/90 with stress and after one week blood pressure normalized to 121/68. Toprol was reduced to ½ to 1/2 of a tablet daily and tapered to every other day for one week and discontinued when pulse did not increase with tapering. (U.) Drug Discovery

Of 70 studies of the foregoing 247 clinical and preclinical studies, representing 44 bio-chemicals, 27% (12 of 44) demonstrated a 3-D bio-chemical trend. This trend is also compnteri∑able and provides positive therapeutic results, killing in excess of 88% of cancer tissue within 24 to 48 hours. Five (5) of these studies demonstrated a cancer cell kill rate of 99^o/_{o t0} 100% in the same time frame. This is particularly noteworthy since these results were achieved using FDA pre-approved-as-safe components comprising subject composition therapeutics synthetic cell-like micro-environment therapeutics. Including additional data of hydrophilic components in their entirety representing therapeutic subject composition components, the additional 2as seen in the enclosed in-vitro anticancer study example tables representing 73% and 83% efficacy would increase the yield of this drug discovery study to 12 of 44 or 31%. This is even more significant when one considers that these organizational component matrices of therapeutic composition of matter are being used here synergistically. Therefore we would expect a synergistic anticancer therapeutic efficacy based on the progressive development of this anti cancer therapeutics as presented here.

This high degree of anticancer therapeutic safety, along with anti-cancer therapeutic efficacy is emphasized here in that these results are derived from components bases on mimicking human tissue through the use of biochemical equivalents of human tissue, that are also FDA pre-approved-as-sqfe. The present invention therefore contributes to anticancer therapy based on these cell and micelle models, and at the same time significantly reduces the risk, if any, in the use of these compounds in the management of cancer. If we include all the components so directed by using therapeutic subject composition, which also have hydrophilic activity, we have an efficacy that starts with 73% anticancer activity. In the case of the organizational extra cellular matrix collagen bovine, tracheal cartilage derived of therapeutic subject composition with similar cancer kill rate efficacy to the 0.125 % (polysorbate 80) Tween 80 of 76 %. Precursor L amino acids and glycine in the molar ratio of developmental protein (to enhance the structural and functional completion of neurologic and other organ development from newborn infant to age one showed an anti-cancer kill rate efficacy of 83%. When used synergistically with organizational cell membrane matrix component of therapeutic subject composition of matter of egg yolk phospholipid emulsion 1.2% diluted 1 :80 showed an anti-cancer kill rate efficacy of 88 %. With the added advantage of these components being FDA pre-approved-as-sqfe, significant anti cancer therapeutic potential arises.

The foregoing is statistically significant, since the current technology of early stage drug discovery utilizes comparative biochemical structures and through computer search commonly requiring 3 million studies so that 1 chemical might be found. If we add the criteria of drug discovery used in the development of this composition of matter into the computer search, the yield would be even significantly less. For example, to achieve this degree of safety, another computer search would have to be superimposed. This would further include a track record of safety over several decades as in this subject composition of matter. Therefore the yield of available compounds would be significantly lessened even more so. If the criteria of the computer search further included simultaneously mimicking human tissue and immunologic 'self as biochemical equivalents of human tissue and its micronutrient and microenvironment of immunologic self, this would even further lessen the yield of potential new compounds. The 3-D stereo fit of organizational matrices, as illustrated in this subject composition therapeutics, is essential in all therapeutic activity, not only for efficacy, but also for safety. Where else could we find such biologic fits besides the FDA pre-approved-as-safe components and their biologic origin of plants and animal derived sources? This appears to account for our 27% yield in search for anticancer efficacy in new drug discovery, in contrast to 1 in 3 million. Cell and tissue ordered repair and regenerative healing are provided in this drug discovery technology as applied to this subject composition that was derived by mimicking human tissue with the use of these 3-D stereo-chemical organizational matrices' integrative fits. This is exemplified by its ability to reverse diseases of poor prognosis, including cancer, without any apparent undesirable effect. Thereby a therapeutic reversal is provided for damaged tissue, and the disorder and entropy of disease.

This also provides a methodology for drug discovery by co-using in the therapeutics of an existing veterinary disease. At the same time this represents a method of drug discovery in animal testing with use in an existing analog disease model. This was accomplished without experimentally producing a diseased model in an animal, representing an ethical and humane advance in drug discovery as well as a significant economic advantage in greatly minimizing the costs that are escalating in drug development by accomplishing two beneficial therapeutic effects at the same time.

This progression of filed and issued patents provides a cell biology matrix with self validating mechanisms of the healing process of the synthetic cell-like microenvironment that industry can build upon through further practicing and advancing this patent. The pharmaceutical industry may benefit from this advantageous position by developing and utilizing therapeutic products thereof. At the same time the pharmaceutical industry will still find themselves within the fundamental scope, and chemical infrastructure of the matrix of cell biology mediating healing and disease reversal.

4. Individualized Therapy To optimize therapy with the present invention, an individual profile of each patient is compiled and stored. Information collected includes blood protein types, lipid levels, DNA sequence, nutrient component levels in the blood including the amino acid composition, and nutrient levels in the cells, tissue and organs. In particular, amino acid composition of organs and tissues is collected. This information may be used to individually design a therapeutic formulation, which includes the L amino acids in molar ratios dictated by the cell and tissue analyses. Furthermore, blood and tissue samples may be stored for future comparative reference.

It would be advantageous to employ computer software that could help identify preferred therapeutic formulation components and their molar ratios based upon a comparison of formulations administered to patients having similar profiles. Also, computer software could be designed to compare the chemical components of particular ribosomes or tissues with the structures of L-amino acids and provide an amino acid formulation that corresponds to the chemical components in their correct molar ratios in a particular ribosome. Ribosomes are the organelles of protein synthesis. Diseased tissue may be chemically analyzed and compared with healthy adjacent tissue to determine the nutrients needed using specially designed software. Nutrient-specific stains such as Coommassie Blue may be employed to identify amino acids, proteins, and other nutrients in tissue samples. MRI spectroscopic analysis and other analyses known to those of skill in the art, may be used to determine tissue and cell chemical composition and thereby discover the deficient nutrients.

It is also envisioned that a medical professional will track the success of the therapy by measuring the chemical components, including the nutrients, in the damaged or replaced tissue during the period of therapy. Such measurements may be made by the invasive practice of tissue biopsy. Preferably when biopsy tissue is removed for diagnosis for another aspect of the patient's therapy, some tissue cells will be used for a nutrient composition analysis. For example, some patients suffering from Crohn's disease may have tissue removed for diagnostic purposes. Such tissue could also be used for a nutrient composition biopsy (with molar ratios). Also, non-invasive methods of measuring tissue or cell composition, such as MRI spectroscopic analysis, blood analysis, analysis of secreted liquids, and other analyses known to those of skill in the art may be used.

5. Diagnostic Methods for Milk Allergies The present invention also concerns a novel method and device for diagnosing milk allergies. It has commonly been supposed that milk proteins and milk sugars apparently acting as haptenes arc responsible for milk allergies. The diagnostic methods of the present invention are believed new because they are based upon the belief that the principal allergens in dairy products are not milk proteins and milk sugars. They are rather the metabolic and catabolic products of bacterial activity and of viral activity, and also bacterial and viral proteins resulting from bacteria, mold and viruses present in dairy products. Thus, testing for allergic responses to bacterial and viral proteins and by-products is appropriate to diagnose and treat milk allergies. Accurate testing for milk allergies would be very useful to allow correct diagnosis and proper treatment of these allergies. Without limiting the invention, it is believed that microorganisms, including bacteria and mold, and viral proteins rather than milk proteins and sugars give rise to milk allergies for the following reasons. First, milk allergies currently are associated with almost 100% negative skin tests when the protein fraction of milk is used as the suspected allergen. It is believed that the carbohydrate and lactose fraction of milk harbors microbial agents and, therefore, this fraction should be tested to diagnose milk allergies. Second, although lactase when added to milk provides milk that does not give rise to allergic responses in many patients, the lactase used commercially is present with unnamed proteases that degrade allergenic microbiologic and viral proteins. Thus, the success of lactase-fortified milk products may be due to degrading microbial and viral protein products rather than degrading milk proteins and milk sugars.

Without limiting the scope of the invention, it is believed that the catabolic and metabolic products of bacterial and viral activity function in at least two ways in the mammalian body. First, such products are believed to drive protease activity in the direction of protein degradation under the law of mass action. Second, such products operate as allergens in sensitive patients. By avoiding foods containing these products, allergies, particularly milk allergies, are treated and allergic symptoms are reduced.

To aid these goals, allergies, particularly milk allergies, can be diagnosed by testing for allergic responses to bacterial and viral proteins, and to catabolic and metabolic products of bacterial and viral activity. In particular, it is believed that by testing for response to bacterial lipopolysaccharides ("LPS"), many milk allergies may be diagnosed. Other possible allergens are proteins produced by rotavirus and avian or bovine tuberculosis.

The physical methods of immunological testing are well known to those of skill in the art. For example, an immediate allergic response can be shown in a positive result to a skin test. If a skin test does not show a response, then it may be advisable to inject the skin intradermally to determine if a response occurs. A delayed response may be shown several ways. For example, the patient may notice a response to a skin test 48 to 72 hours after the skin test is administered. Also, the patient may notice coughing or wheezing, or have great intestinal distress 48 to 72 hours after a suspected allergen is contacted with the patient's skin.

More particularly, allergens may be identified by using one of the following diagnostic tests. To test for hypersensitivity to viral proteins and the products produced by viral activity, including rotavirus antigen hypersensitivity, an extract is prepared from the extra embryonic fluid of a chicken embryo infected with the virus. The extract is concentrated and purified by differential centrifugation. The virus is killed with formaldehyde solution ,1 :1000, and is diluted with isotonic sodium chloride solution. The resulting product contains approximately 0.012 moles glycine, and less than 1 :8000 formaldehyde solution. Thimerosal is added as a preservative 1 :10,000. Each ml of the skin test antigen contains 40 complement-fixing units. After shaking, the product is slightly opalescent. The product is administered first as a skin test. If the patient shows no response, the product is administered intradermally, in 0.05 cc and then 0.1 cc dosage if 0.05 cc intradermally is negative. The test, like a tuberculin test, is read 48 to 72 hours after contact with the suspected allergen. The test is also read immediately after the scratch test, and 10 to 15 minutes after the intradermal test.

A test for bacterial hypersensitivity may be performed similarly to the example provided for viral hypersensitivity and according to standard methods of making and administering bacterial vaccines and allergenic extracts known to those of skill in the art. Such tests preferably include analyses of hypersensitivity to bacteria common in dairy products and their flora, catabolic, and metabolic products. Tests for hypersensitivity to molds found in milk products may be performed using methods similar to those disclosed herein for allergenic extracts and the knowledge of one with skill in the art.

These microorganism agents in milk allergy are believed to include debris of microorganisms killed by pasteurization, which maintain allergenicity even after the microorganism is no longer infectious. Preferably immunological testing for milk allergies includes testing for these agents.

It is well known that dairy cattle are exposed to viruses and bacteria, sometimes at high levels, which would give rise to the appearance of viral and bacterial allergens in milk. For example, British dairy scientists found that paratuberculosis spread quickly through water ponds where fecal paratuberculosis ileitis was present. The spread of this disease was limited by using drinking troughs and by raising the pasteurization temperature 3°C. 75°C, from 72°C.

As confirmation of the present theory, it is noted that sheep, whose meat and milk products are much less allergenic than beef and cow milk products, have a low incidence of paratuberculosis. The incidence is as low as 1% in diary sheep. A low allergic response to food from animals with low incidence of viral and bacterial infections is expected under the present theory.

The invention also concerns a device to use in skin tests for immunological responses. In a preferred embodiment, the device is a test unit consisting of a stainless steel disc attached to a handle, preferably a plastic or wooden handle. Projecting from the disc are 4 triangular- shaped prongs (tines), which are 2 mm long and approximately 4 mm apart. The tines have been mechanically dipped into a solution of Old Para- Tuberculin, containing 7% acacia (gum arabic) and 8.5% lactose as stabilizers, and then dried. The entire unit has been sterilized by Cobalt 60 irradiation. No preservative has been added. Because the unit is disposable; there is no need for syringes, needles, and other equipment necessary for standard intradermal tests. The test can be read in 10 to 15 minutes, or 48 to 72 hours later. The unit can be used more safely than these prior art devices and is expected to result in a lower level of accidental needle sticks than found when syringes with needles are used.

6. Convergence technology regarding anticancer therapeutics and associated interdependent convergent diagnostic system technology—Polarizing Microscopy:

Endoscopic Examination Equipment, Polarizing Microscopy Probe integrating the aid of polarizing fiber optics for transmission of polarized light. Also utilizing the leading advances in polarizing microscopy developed for in-vitro fertilization in studying adequacy of fertilized egg for normal pregnancy.

In one embodiment, a probe is attached to standard endoscopic examination equipment, which in turn can be activated to help clarify a question with regard to the lesion detected. It is believed it might provide not only findings associated with gross inspection endoscopic examination, but also augment the opportunity for detecting malignant (neoplastic potential) screening test. This will be similar to the adaptation of the dissecting microscope about 40 years ago to advance neuro-surgery and particular skull base surgery. Practicalized further and in a further embodiment, a few millimeters of pressure of a vacuum is applied to insure, at that time, imminent contact with mucosa such as, but not limited to gastrointestinal, respiratory tract and urinary tract. Providing a quick noninvasive confirmatory screening test under these drastic circumstances.

Polarizing microscopy can be used both with reflected and transmitted light (analog to a diamond). Reflected light is useful for the study of opaque materials such as mineral oxides and sulphides, metals and silicon wafers (Figure 3). Reflected light techniques require a dedicated set of objectives that have not been corrected for viewing through the cover slip, and those for polarizing work should, again, be stress free. It is believed that a significant portion of polarizing light aid in imaging cell biology such as cell membranes and spindle is analog to the polarizing light that penetrates and is further being trapped is analog to the scintillation and shimmering of a multi-faceted diamond. This is further analog to the birefringence light like effect of light trapped in a neon sign.

Disclosed in this application is a therapeutic stem cell stimulating, growth factor that has been successfully useful in disease resolution as well as normalizing neuronal flow in pain management. In tracking the biomarkers of disease associated with the development of this growth factor, there has been a progressive development of equipment that would significantly augment the dissecting microscope that has been so skillfully applied in surgery, including robotic surgery and neurosurgery, as well as skull base surgery. This visualization of the biomarkers of disease can be diagnostically used to track therapeutically non-invasive, as well as invasive surgical care including neurosurgery. The transdermal therapeutics and the adapted surgical and neurosurgical equivalent will be used therapeutically to enhance precision of application as well as being incorporated in this instrumentation for non-invasive tracking of therapeutics, as well as surgical tracking non-invasively of the therapeutics of these diseased biomarkers similar to the adaptation for endoscopy to further help identify and distinguish normal tissue from abnormal tissue thereby preventing trauma to normal tissue in surgical care. This will augment the dissecting microscope in surgical and neurosurgical care To be used as an excision of a benign tumor as an acoustic neuroma positioned in a malignant skull base position to provide very cautious microanatomic guidance to prevent transaction of the normal facial VII nerve, a not uncommon complication of this neurosurgical procedure result in a stroke like interference of facial expression and smile as well as interference of speech.

Birefringence is particularly useful in the study and visualization of liquid crystals, particularly those with a hydrophilic lipophilic balance (HLB) of eight or greater, as seen, for example, in the phospholipids. Of particular note is the phosphatidyl choline work significantly pioneered by Neil Krog in studying the molecular embryologic work of egg yolk phospholipid initiated in food science. This instrumentation polarizing microscopy technology can be used in- vivo or in- vitro in tracking such biomarkers as a membrane of human and mammalian cell, nuclear, organelle. In fact it is believed that the nuclear membrane material that provides the birefringence scintillation of the spindle is derived from the now absent meiosis and mitosis (including the abnormal mitosis of cancer) nuclear membrane nucleolar membrane and nucleolus. As well as it is believed its implied absence in the associated dense nonfunctional regard to templating proteomics of protein production. The inventor has used egg yolk phospholipid incorporated in Abbott Laboratories, Chicago, IL and Baxter Laboratories, Chicago, IL in advancing the potential for disease resolution in the ten day study of end stage cancer with such FDA approved products such as 10% to 20% with 1.2% egg yolk phospholipid Liposyn, Abbott Laboratories, Chicago, IL or Intralipid, Baxter Health Care, Deerfield, IL (see US Published Application No. 2007/0037777 Al, filed Feb.15, 2007 and U.S. Published Application No. 2005/6, 974, 796 Bl , filed Dec.13, 05, both of which are incorporated herein by reference.) See also Figure 17A and Figure 17B from Larsson, K. and Friberg, S Food Emulsions, Page 158 and 171, 2^nd Edition Marcel Dekker. Inc. New York and Basel.

Illustrated in Figures 16A-C is a series of reflected polarized light photomicrographs of typical specimens imaged utilizing this technique. On the left (Figure 16A) is a digital image revealing surface features of a microprocessor integrated circuit. Birefringent elements employed in the fabrication of the circuit are clearly visible in the image, which displays a portion of the chip's arithmetic logic unit. The polished surface of a ceramic superconducting tape (Yttrium- 1,2,3) is presented in Figure 16B. which shows birefringent crystalline areas with interference colors interspersed in a matrix of isotropic binder. Metallic thin films are also visible with reflected polarized light. Figure 16C illustrates blisters that form imperfections in an otherwise confluent thin film of copper (about 0.1 micron thick) sandwiched over a nickel/sodium chloride substrate to form a metallic superlattice assembly, (see full article at: www.microscopw.com/articles/polarized/polarizedmtro.html)

Instrumentation that we have shown through microscopy examples, such as but not limited to those disclosed by Cambridge Research Institute (CRI) in Figures 12A and 12B is dependent upon liquid crystal hydrophilicity and its associated biophysical features of birefringence of polarizing light. Such visualization may be maximized and optimized by visualization technology such as but not limited to polarizing light. Building on the technology of Cambridge Research Institute (CRI), camera-like equipment, such as, for example, that available through CRI, can be utilized to determine the degree of molecular order. One embodiment utilizes the CRI Oo-sight or Lf equipment as a camera with Bectra inform software operably attached via USB cable to a computer, as well as, liquid crystal compensator. This equipment is readily adaptable to an Olympus, Zeiss, or Leica microscope. This is the same equipment utilized by known in-vitro fertilization groups to determine the viability of the in-vitro fertilized egg and in preventing and discarding abnormalities found in in-vitro fertilized eggs. Such abnormalities qualify for destruction, minimizing the risk of multiple births or other abnormalities. In contrast, normal spindle formation observed by polarizing light microscopy has been found to predict the level of normal birth success by as much as 60% to 70%. However, to our knowledge, this technology has never been used to track and understand the pathogenesis of cancer and track its associated mutagenicity. Since the in-vitro fertilization groups using polarizing microscopy technology are able to infer mutagenic changes such as multiple births or other abnormalities, it seems logical and it is believed that the same mutagenic tracking can be used in regard to detecting potential mutagenic changes in observing and studying the vital tissue of cancer (analogous to comparative studies of the cancer tissue with adjacent normal tissue). It is further believed that it is possible to observe and track cancer normalization of the micro-environment treated with the subject composition therapeutics. Therefore, the mutagenic, genomic, and proteomic normalization that ensues also the normalization of the DNA and RNA polymerases and prolonged presence inflammatory changes that have repeatedly been observed associated with not only cancer are normalized, but also the further complications of metastasis. The associated normalization of proteomics would be of great value in tracking and advancing the treatment of diseases such as cancer in a similar comparative way. Subject composition therapeutics includes use of advanced proteomics in protoplasmic protein advanced healing in conjunction with redirecting and normalizing the persistent and aggressive immuno- inflammatory response system. This results in a significant increase in an ti -inflammatory receptor antagonists along with equivalent decrease of inflammatory protein interleukins

(cytokines). This FDA approved therapeutics is a steroid sparing/substitute. It has this been used to track the pharmacology, cell biology and pharmacodynamics of normalizing tissue treated with therapeutics such as, but not limited to, the subject composition. This is a particularly advantageous opportunity since meiosis or mitosis and the associated spindle formation and liquid crystal studies provide such a unique fit in comprehending the pathogenesis of cancer as viewed in our associated subject composition patent filings. This is exemplified by the particular regard of the ability of spindle formation and its believed involvement in the pathogenesis of cancer, and the lipophilic micelle that we have used and believe represents the cancer molecule. This work will provide the basis for a non-invasive technology for obtaining biopsies, with a particular, but not limited to, emphasize on cancers.

The liquid crystal polarizing light message will be transmitted by polarizing light fiber optic cable, (available by such company as Corning), to a computer chip readout of degree of polarizing light birefringence, (a high level of birefringence is a measure of tissue normality), similar to what had been used when developing the Oximeter with Hewlett Packard.

Additionally we know that the penetration of the polarizing light is at least 100 microns. This is based upon the fact that the polarizing light can be used to study and penetrate a human embryo and stem cell with which the technologists have worked. This is in sharp contrast with light microscopy used in histopathology where the tissue must be no greater than 4 microns in thickness to permit light penetration. This addition provides the instrumentation and ability to make vital live tissue available not only for diagnosis but also for study that has not been available in the prior art to date.

Maintained at 37°C and immediately examined under a polarizing microscope to augment visualization of tissues, we utilized their associated liquid crystal birefringence as a substitute for tissue staining to permit examination under microscope. This has been done in fertility studies but not other diseased tissue biopsy examinations with particular interest in cancer.

This instrumentation is being planned to be carried out in two centers. Also, non- invasive application technology of augmenting and/or replacing the invasive biopsy is being carried out.

Additionally, the cancer mechanism focused in nucleus and its associated genomic cell divisions that start in the nucleus DNA have chromatin changes mediated by nuclear spindle formation. It is believed to be locked in cell division spindle formation such as anaphase. This cancer resolution may be visualized under enzymatic apoptotic cancer disease resolution and including subject composition mediated by current and advanced therapeutics. Conventionally and routinely, polarizing microscopy has been confined to solid crystal study and has been used in some centers to differentiate uric acid crystals from calcium pyrophosphate crystal deposits in gout

Polarizing light microscopy will allow us to better evaluate structure and function. For example the multiple studies that were done in the cited reference using phospholipids to increase the blood flow by 25%, suspected but never documented, to be due to increased pliability of erythrocyte cell membrane, which can be advantageous in atherosclerosis where blood flow is impeded, would be detectable. We would be able to hereby detect efficacy non- invasively. It is believed this polarizing light microscopy equipment would help to provide vital tissue examination rationale so that we could observe the red blood cell flow through the capillaries. In the suggested reason of increase red blood cell plasma fluidity membrane studies existing studies that have been done have not provided rationale there are not alternation is plasma viscosity, sedimentation rate or other standard blood parameters were not found to be altered. In studying the phospholipids, such as phosphatidyl choline, efficacy of increasing blood flow by 25% we make comparative studies before and after the phospholipid using the more translucent web area of the skin between the thumb and index finger as well as the nail beds to determine practicality. (This is analog to pulse oximetry studies of oxygenated blood.)

It is believed that this can be a marker for normal tissue in contrast for example to cancer (in that cancer has the lipophilic micelles). This foregoing hydrophilicity can be used as a detectable measuring stick of normal tissue activity by polarizing light probe using polarizing fiber optic cables to carry the light from the polarizing probe serving as a mini polarizing microscope that is heated to 37 degrees centigrade and will carry this light message via polarizing light optical cable provided by a company such as Corning, to the computer chip adapted to read quantitatively the degree of birefringence luminescence. This serves as a non-invasive tracking system for therapeutic comparative efficacy of medication and minimizes the need for animal studies as well as serving as a non-invasive equivalent to biopsy in the case of cancer. It can also be used for tracking pharmacologic and pharmacodynamics therapeutic effects on multi-species in pre-clinical animal work and human clinical pilot studies. This technology applying polarizing light microscopy is not limited to biophysics modality.

At the present state-of-the-art, the only vital tissue that has been exampled we believe to date is the in-vitro fertility studies of the egg and sperm polarizing light microscopy thereby visualizing vital living tissue and its morphology as well as biochemistry. This biochemistry is illustrated by the fact that the essences of cell membranes of living tissue are dependant upon phospholipids such as phosphatidyl choline and its liquid crystal characterizing birefringence. In routine histopathologic stains alcohol toluene (similar lipid solvent and lipid removal chemicals) such as those chemicals analogous to the dry cleaning industry washed away the normal chemical with a lipid component and replaces with paraffin. Therefore this tissue represents an artifact of structure and biochemistry which is consistent and represents the bases such as routine hematoxylin and eosin staining (HE). Also, thin slicing of the four micron thick tissue allows it to be placed on glass and the frozen section for cancer also distorts since it is no longer a live vital tissue. Vital tissue is ideal to track the biochemistry of diseased tissue versus normal tissue and therefore applicable in tracking the biochemistry of subject composition therapeutics. With further sophistication of the technology, micronutrients, vitamins and minerals might also be traceable. Without disturbing current routines, we can use a Touch Prep for histo-cytologic studies, to confirm, for example, the presence or absence of malignant cells which can also be examined as vital tissue under the polarizing microscopy with a heated stage (37 degree Centigrade (98.6 F) normal human body temperature). When adapted to other mammalian tissue the heated stage has to be adjusted to the normal temperature of the animal species (for example certain animals have a normal temperature of 101 ° degree F). Additional tissue has been put aside for HE stain in the case of the frozen tissue section. Small amounts of this tissue can be examined under the polarizing microscopy with the added advantages of vital tissue examination and it associated undisturbed biochemistry. This study will have to be adapted to histopathologic orientation and training as was the case for the neophyte pathologist.

These biophysical features of birefringence are also evident in the extracellular matrix such as, but not limited to, collagen. This is based on hydrophilicity charts of the amino acids (see, for example, the hydrophilicity table on IBD part II, page 26).

Tissue might be considered analogous to an alloy and this analogy of the biophysics of human tissue measurements with the instrumentation we proposed might be compared to the tonal quality of a bell made of an alloy of copper. When copper contains 10% tin, it has been continually observed that it has the greatest tonal qualities as a bell. The ratios and synergy including the birefringence light response might be consider analogous to tonal bell copper and the beautiful sounds of the tone bell copper bell.

Utilizing live tissue treated with the composition of the subject invention, the effects thereon can be seen with polarizing light microscopy, such as that which has been applied to the studies of human fertility and the ovum. The cancer tissue, of the HeLa cell line, was treated with a composition having some or all of the components disclosed in U.S. Patent 6,974,796, to provide the associated biophysical properties of light transmitting properties of these components, such as, but not limited to, the birefringent luminescence shimmering of light. This biophysical feature of biochemicals that mimic human tissue and its progressive steps in activation of the sleeping egg by fertilization and is also applicable to healing and the principles of using the stem cell as a future therapeutic agent under progressive study for efforts to obtain approval. However, we have presented here in the biochemicals of components IA, IB and 1C, described in further detail below, replicating human tissue and also replicating human tissue healing stem cell capacity stem cell stimulating factor and growth factor as well as the molecular embryologic capacity in proving a cell free variant of human tissue components that serve competitively and synergistically as anti-inflammatory protein synthesis healing agent with the ability to serve as a steroid substitute or steroid sparing agent in healing. FDA approved-as-safe in accordance with the code of federal regulation CFR-21 and without any known side effects to date when used as prescribed along with the micronutrient minerals and vitamins in these progressive patents. All of components Ia, Ib and 1 c are liquid crystals that can be identified by birefringence by using a polarizing microscope with heated to body temperature stage (98.6F). Using the liquid crystal biophysical properties of birefringence under the foregoing polarizing microscopy these light signals should be able to be conveyed by fiber optic cable (ideally a fiber optic cable polarizing light transmitter probe provided by such companies as Coming Glass, Concord, NY). A fiber optic cable polarizing light transmitter and a probe could be provided along with a computer chip read-out whereby it is believed that normal tissue from abnormal tissue can be studied to provide information currently available by biopsy and staining such as H and E (hematoxylin and eosin) tissue with the possibility of certain masking technology. This includes masking out any light transmission from lipophilic micelles characterizing cancer.

Isotropic materials, such as gases, liquids, unstressed glasses and cubic crystals, demonstrate a homogenous composition having the same optical properties in all directions. They have only one refractive index and no restriction on the vibration direction of light passing through them. In contrast, anisotropic materials, which constitute approximately 90 percent of all solid substances, have optical properties that vary with the orientation of incident light with the crystallographic axes. They can demonstrate a range of refractive indices depending both on the propagation direction of light through the substance and on the vibrational plane coordinates. More importantly, anisotropic materials act as light beam splitters, in that they divide light rays into two parts (as shown, for example, in Figure 15). The technique of polarizing microscopy exploits the interference of the split light rays, as they are re-united along the same optical path to extract information about materials, including living tissue.

The birefringence of the hydrophilic surfactant properties of as phospholipids, such as, for example, phosphatidyl choline, and highly sulfated ECM (imparting similar synthesis of healing 42% increase in tensile strength of wound with subject composition treatment. Wound tensile strength increases and is analog to Kevlar (a nylon polymer highly sulfated with bullet proof strength) and it is believed to include hydrophilic surfactant amino acid components of hydrophilic proteins should not only impart a signal or birefringence of polarized light under polarizing microscopy at body temperature of 98 degrees (enhancing equivalent to biopsy findings and availability as non-invasive new instrumentations. This also teaches tracking of biomarkers subject composition immunotherapeutics with polarizing light new instrumentation offered here recovery disease resolution using subject composition therapy. This appreciation of interdependent technology starting with hydrophilic surfactant activity of normal tissue to not only be pivotal to reversing the lipophilic micelle found in cancer but also to reverse cancer's guise as repeated wounds that fail to heal. Also provides liquid crystal birefringence characteristics of liquid crystal highly hydrophilic features of normal tissue components essence of cell membrane with automaticity to biorobotic form cell membrane thereby cells as is also the case with ECM (extracellular matrix) and normal water soluble protein a plurality of amino acids including there of high HLB (see Kinsella, text quote and chart) and particular amino acids in normal molar ratio as human tissue and mammary gland milk equivalent to liquid tissue secretion and its development as a fetus and newborn (in view of articles from the National Archive Library of Medicine for example several hundred articles of deficiencies of micronutrients of such disease as, but not limited to, hypertension). A polarizing fiber optic cable can transmit this probe message of light and total birefringence of liquid crystal components (replicated in 6,974,796 Bl). This can be utilized for tracking disease resolution for treatment of patients with diseases of poor prognosis. Prior to treatment each patient's disease will be studied and measured by this inventive instrumentation, in terms of disease biomarkers in tracking therapeutic response and disease resolution. This will also be used in tracking as a tissue index of disease, as applied in measuring the degree of cancer predisposition and inability to heal, not only in cancer but also in the inability to heal as in the case of wound healing.

Components of the Composition disclosed in U.S. Patent No. 6,974,796, exemplified when used successfully in a patient in his early 80s, with a diagnosis of coronary artery disease, associated with periodic tiredness and weakness due to mild mitochondrial deficiency**:

Laboratory findings include homocysteine 8 mg. because of the increase to 13 mg. the following modifications were made: * The patient is greatly improved in terms of periodic weakness with the following therapeutics:

• Vita Carte 2-4 capsules, 2-3x per day (Phoenix Biologies Inc., Vista, CA.)

1. Chondroitin Sulphate 750mg

2. Type II Collagen 720mg

• Phosphatidyl Choline 1 capsule 3x daily, (J .R. Carlson Laboratories, Arlington Heights, IL.) 1. Phosphatidyl Choline Complex 1200mg

2. Phosphatidyl Choline 400mg

• C-GeI 1 capsule 3x daily, (J.R. Carlson Laboratories, Arlington Heights, IL.)

1. Vitamin C lOOOmg

• Super 2 Daily 2x per day (J.R. Carlson Laboratories, Arlington Heights, IL.) 1. Micro-nutrients: Vitamins and Minerals

2. Vitamins: A 10,000IU₅C 500mg, D3 600IU,E 400IU, Bl 25mg, B6 25mg & B 12 lOOmcg

3. Niacin 25mg

4. Folate 800mcg, with the recent addition of 5 methyltetrahydrofolate, 1000 meg. Life Extension, Hollywood, FL * in addition to Pantethine 450 mg.

Jarrow Formulas, L.A. CA. Riboflavin (Bi) 100 mg., 1 capsule 1 to 2 times daily 5. Biotin 300mcg

6. Pantothenic Acid 25mg

7. Calcium 50mg

8. Iodine 150mcg 9. Magnesium lOOmg

10. Zinc 15mg

11. Selenium 200mcg

12. Copper 2mg

13. Manganese 3mg 14. Chromium 200m eg

15. Lutein 500m eg

16. Lemon Bioflavonoids Complex 25mg

17. Lecithin 60mg

18. Phosphatidyl Choline 50mg 19. Phosphatidyl Ethanolamine 3mg

20. Fish Oil Concentrate 770mg. ■ EPA (Eicosapentaenoic Acid) 130mg ■ DHA (Docosahexaenoic Acid) 90mg

● Methyl B₁₂ 1000 meg, 2 to 3 times daily, Jarrow Formulas Inc., Los Angeles, CA

● Norwegian Salmon Oil 2 capsules 3x daily (J.R. Carlson Laboratories, Arlington

Heights, IL.)

1. Omega-3 Fatty Acids 750mg

2. EPA (Eicosapentaenoic Acid) 360mg

3. DHA (Docosahexaenoic Acid) 250mg

● L-Arginine, 500 rag. 1 3x per day (The Vitamin Shoppe, North Bergen. NJ.)

1. Vitamin B 6 lOmg

2. An alternate form maybe be used instead, 2 capsules daily (long acting) L- Arginine l,000mg & Time-Sorb 400mg, Thorne Research Inc., Dover, Idaho

● Neocate 2tsp (approx. 1 Ogm) l-2x per day (Nutricia North America, Rockville, MD.) 1. Amino Acid Based Infant Foπnula with Iron

● Magnesium Taurate 2x per day (Cardiovascular Research, LTD. Concord, CA.)

● Magnesium Taurate L-carnitine 250mg TwinLab, Corporation, Hauppauge, NY ** ● Co-enzyme Ql 0 50mg, Life Extension, Ft. Lauderdale, FL.

● (discontinued because of GI intolerance:) Flax Oil 1-2 capsules 2-3x daily,(Barlean's Organic Oils, Ferndale, WA.)

The above composition was used by a patient in her mid 70s, with the addition of L Tryptophan, NOW Foods, Bloomingdale, IL, and has been helpful at bedtime to encourage sleep. The foregoing male patient with benign prostatic hypertrophy (PSA of 4.2 and so maintained) had a reduction in nocturia from 3x to 2x per night with Beta Sitosterol 300 mg. Complex, available as Heart Choice Plant Sterols, The Vitamin Shoppe, North Bergen, NJ. His predisposition to gout was greatly improved with diet and Quercetin Complex, 500 mg., Quercetin, and Bromelain, 2000 Gdu per gm., Solgar Vitamin, Leonia, NJ.

You can further watch the treatment evolve in healing with this inventive therapeutics, but also provide and make more available biopsies in a non-invasive format. This can be done with the polarizing fiber optic cable to send a message from the probe to the polarizing light fiber optic cable to a computer chip then the machine measures the degree of birefringence and instrumentation read out of interference of healing and predisposition on cancer.

To clarify, with this technology, it is a possible consideration that further predisposing inadequacies and deficiencies in tissue might also be detected by the birefringence pattern that correlates with bio-chemical polar surface active hydrophilicity associated it is believed with healthy tissue. Therefore an association of selenium deficiency not only in reducing biologic competition thereby allowing not only the influenza virus to prevail but increasing the predisposition to cancer might also correlate with abnormal findings of birefringence. "There is growing evidence that higher Se intakes are associated with reduced cancer risk. " "More recent research has shown that a mild strain of influenza virus, influenza A/Bangkok/I /79, also exhibits increased virulence when given to Se-deficient mice. " f6,974,796 Bl column 16, end of table 2)

It has been shown in 70 in vitro studies and in about 10 patient pilot studies that through the same phospholipid we can normalize the programmed end of cell life cycle (apoptosis) not only with the phospholipid, but with all the foregoing components of IPFs wound healing therapeutics. This in turn, in primate alcoholic cirrhosis experiments, can be normalized again by use of phospholipids followed by hepatic cellular repair and regeneration. As well as, phospholipid activation of collagenase to replace cirrhotic fibrosis (documented by Lieber). This is analog to fertilization with the cell membrane's fusion dependent upon phospholipid. The activation of enhanced hydrophilicity by fertilization and sperm injection of phospholipase at the cell membrane site of entry is shown here.

This polarizing light instrumentation that measures birefringence as an index of hydrophilicity in biologic tissue will also give us a quality control 3D analysis of treatment agents analog to typing and cross matching in preparation for transfusion to avoid reactions. This is analog to the quality control polarizing light instrumentation in tracking food science. An example is the stability of an emulsion and colloid system. In fact, this will help us visualize that the body is about 60% water in a colloid system where water is bonded, as well as, an emulsion where water is entrapped from a 3D biochemical engineering standpoint.

HLB and surfactant parameters are very difficult studies to do, whereas this polarizing light instrumentation will allow us to spot and check degrees of hydrophilicity by this 3D charged particle suspension analysis. Adding this technology and its computerized readout is believed to enhance and expedite drug discovery that would mirror, replicate and offer a 3D fit of the drug with the tissue implication. It is believed this will change the odds from 1 -3 million in the computer search to our findings of about 1 and 4 of tolerance and therapeutic response. Component Ia: A highly sulfated extracellular matrix:

This component comprises at least one extracellular matrix compound in an amount effective in the damaged tissue as anti-inflammatory and anti-neoangiogenetic agent, wherein said extracellular matrix compound is selected from the group consisting of a glycosaminoglycan, a collagen, cartilage, chondroitin sulfate, a glycoprotein, and a proteoglycan. The hydrophilicity of the extracellular matrix is dependant upon the sulfated proteins which not only add strength an increase of 42% of tensile strength in wound healing but also the biophysical feature of birefringence.

Collagen deposition and remodeling are central processes in biology and disease. Conventional methods of visualizing collagen require special stains (trichrome, picrosirius red) and, typically, cutting additional sections.

An optical method ("birefringence imaging") developed by CRI and being further modified herein to adapt to the clinical settings and evaluation of therapeutics related to disease and resolution to health biomarkers and can detect collagen because of how this molecule interacts with polarized light. No special stains are required— collagen is revealed with high sensitivity with standard H&E-stained sections. Combined color plus collagen images can be achieved within 15 seconds

The extracellular matrix components when seen under the polarizing microscope do not require any stain. In fact even though the image in Figure 12A was observed on stained tissue most importantly this study can be observed with the study of unstained live tissue such as seen in Figure 12B, utilizing a polarizing microscope, as seen in Figure 13, plus the added heated stage to maintain the temperature at 98.6 F (37° C).

Component B: Polar Surface Active Lipids: Ib. Another component of the subject composition comprises at least one polar surface active lipid, wherein said polar surface active lipid is selected from the group consisting of a phospholipid, a glycolipid and a lipoprotein.

Referring to Figure 1, the lipophilic micelle as shown is characteristic of the cancer molecule viewed here from hystophilology and comparative lipophilicity with an HLB of 6 or less associated with chromatin that is condensed and appears to give the cancer cell the effect of being stuck in its cell cycle and unable to proceed to apoptosis or scheduled cell death. Going "north" on the chart where the HLB hydrophilicity is 8-9 of greater we have found in our 71 in- vitro studies HELA cell, donated by Helen Lane, cancer tissue, anticancer studies that the apoptosis and lethality of the cancer cell corresponded to the exposure to hydrophilic surfactant qualities where the cancer cell was able to proceed to apoptosis.

As detailed in Figure 14, the basis for the anti-cancer effect of the phospholipids and hydrophilic amino acid component resides in the surfactant packing parameter and HLB Generally, the repulsion between two uncharged surfactant-coated surfaces depends upon the hydrophilicity of the surfactant and on the packing density at the surface. The cancer cells shown in Figure 14 already exhibit compromised anaerobic activity, which is further inhibited by the surfactant compressible effect.

Component Ic: Amino Acids

A further component of the subject composition comprises the twenty free amino acids specified by the genetic code of mammalian and more specifically human tissue that include non-essential amino acids: L-Alanine, L-Arginine, L-Asparagine, L-Aspartic Acid,

L-Cysteine, L-Glutamic Acid, L-Glutamine, Glycine, L-Histidine, L-Isoleucine, L-Leucine, L-Lysine, L-Methionine, L-Phenylalanine, L-Proline, L-Serine, L-Threonine, L-Tryptophan, L-Tyrosine and L-Valine, and their associated protein synthesis and folding and biologic characteristics dependent upon 3D folding configurations and further dependent upon the relative HLB of each of these amino acids in their magnet like attraction a repulsion in forming definitive protoplasmic protein with its biologic activity.

Protein Synthesis Matrix and Amino Acid HLB Hydrophilicity Dependent Protein Folding — Basis of Bio-Activity for Compact Disc Software Mediated by Amino Acid Magnet-Like Dipole: The above-listed amino acids function in protein folding as dipolar magnets with forces mediated by the HLB balance, ratios and particle charges where the majority (80%) of essential amino acids are more lipophilic and the branched chain amino acids being the most lipophilic.

Whereas, the majority (80%) of the non-essential amino acids are hydrophilic. These in turn fold in accordance with their relative HLB value so that the essential amino acids can be found "protected" in the center.

The final folded protein is a lipophilic protein core analogous to a fetus being protected by the surrounding hydrophilic surfactant amino acids. These amino acid components are all liquid crystals with amphiphilic polar surface activity, as described in U.S. Patent 6,974,796, incorporated herein by reference in its entirety. The amino acid component functions like Component IB and they glycoprotein ECM of Component IA. Additionally, parts of the ECM have a lipid foot anchor to the cell membrane. These glypicans are being similarly composed of amino acids with a hydrophilic signaling the destination directional carbohydrate moiety for each glycoprotein. The relatively high hydrophilic effect so important in wound healing, are also affected by the components recited in U.S. Patent 6,974,796. It appears that the anti-cancer activity of Components 1 a, 1b, and 1 c is caused by the highly hydrophilic properties, as demonstrated in the 70 in- vitro studies mentioned previously herein.

Figure 4 details the bio-activity and resultant effects of protein folding and production in a living body.

All of these amino acids specified by the genetic code of tissue protein arc amphiphilic (with a 2 to about 9 carbon being the most lipophilic exemplified by the aromatic amino acid phenylalanine having three carbon atoms plus six carbon atoms in a aromatic benzene ring and the amino and carboxyl groups being hydrophilic exemplified by the most hydrophilic amino acids being diamino, arginine and lysine and the dicarboxylic amino acids being aspartic acid and glutamic acid) and are therefore liquid crystals. With it is believed the opportunities of detecting their presence by polarizing microscopy. We therefore, should be able to observe the biochemicals of Components IA, IB, and 1C and observe their activity in healing, molecular embryology as well as detecting abnormal cellular, nuclear activity, extracellular matrix and polarizing microscopy blending further to the opportunity of a probe with these light messages carried by fiber optic cable and tracked by a computer chip so that we can observe abnormalities in structure and function that might include deficiencies such as but not limited to said components, as well as nuclear, cytoplasmic, extracellular matrix distortion of cytoskeletal pattern that is believed to be compositely observable the effects of inflammatory chemicals (such as cytokines, chemokines, prostaglandins). It is further believed that this might be traceable using technology analog to the Oximeter, exhibiting convergence of therapeutic technology with diagnostic technology.

7. EXAMPLES: The following examples are used to illustrate preferred embodiments of the invention and are not meant to limit the scope of the invention in any way. Case 1. Congenital Biliary Atresia An infant, age 3 weeks, weight 6 lbs. (compared to birth weight of 7 lbs.), was critically ill in a hospital with marked jaundice and abnormal liver functions. The diagnosis was congenital biliary atresia, which was substantiated surgically and the Kasai procedure was performed. A liver transplant was scheduled. A clinical strategy was considered in view of the patient's failure to thrive and the harsh planned therapy. Elemental feedings were prescribed.

Specifically, a free L amino acid powdered composition called Neocate (SHS international Ltd., U.K.) was suspended in water at a concentration of approximately 4 to 6 grams, per 1 ounce of water, which translates into approximately 14 to 16 weight % of free L amino acid, based on the total weight of the solution. This formulation was administered orally to the infant about 3 to 4 times daily (about 4 to 8 hours apart); in 6 to 8 ounce dosages over the period of about 6 to 9 months. Foods having exogenous catabolic substrate stimuli, such as all milk products, arc avoided. Unexpectedly, the infant exhibited substantial improvement within 24 to 48 hours after treatment began. The jaundice rapidly receded and the liver functions improved. The rapid, dramatic clearance of the jaundice, along with the normalization of hepatic laboratory results was a most welcome surprise. The improvement continued throughout the course of treatment. After about 3 months of treatment, the infant's planned liver transplant was canceled. The liver was diagnosed as healthy, thus confirming that the infant was making a full recovery. The infant rapidly regained the one pound of lost weight and continued normal weight gain, more than doubling her birth weight at six months, and tripling it at one year. At one year, a liver ultrasound showed a completely normal liver. The treatment was no longer necessary after about 6 to 9 months. Over the course of the next year and a half, the infant showed no signs of relapse and all liver functions remained healthy. This is a dramatic case of unexpected remission of congenital biliary atresia, with the patient no longer requiring transplantation.

Case Study Illustration: Organ Regeneration Tissue Regeneration and Healing

Patient Scheduled for a liver transplantation which was averted with this subject composition therapeutics.

Recovery occurred in approximately one month after treatment and on review by the University Hospital the organ transplant was cancelled and both the liver ultrasound and the liver blood studies normalized. See Figure 9

Case 2. Anaphylaxis to Renal Dialysis and treatment to prevent the need for kidney transplant An adult patient (age 16) had rejected three kidney transplants and was on dialysis. She had severe anaphylaxis to renal dialysis which was averted by the use of the dialysis membrane which is protected from leaching out made by Renal Systems.

To prevent such an outcome of repeated kidney transplant rejection, the following therapy is used. This would also be of value in preventing the likelihood of anaphylaxis et al. as well as maintaining the micronutrient the microenvironment in countering inadvertent losses that might occur with dialysis focused on reducing and removing metabolic waste products particularly urea. The treatment is the administration of 4 to 5 capsules daily, of L amino acids according to the invention. Each capsule contains 390 to 500 mgm essential amino acids in L form and glycine in the molar ratio of infantile developmental that mimicked human breast milk protein and included vitamins and minerals such as Neocate, (Liverpool UK) infant formula and essential lipids particularly in omega-3 fatty acid fats. The therapeutic formulation comprises linoleic and linolenic fatty acid for a total amount of about 0.3 to 0.5 g per day, as Norwegian salmon oil (Carlson Laboratories Arlington Heights IL), 1 to 2 capsules daily, the antioxidant lipid EPA at about 0.3 to 0.5 gram per day, DHA at about 240 mgm per day, and extracellular matrix materials chondroitin sulfate, cartilage, and collagen in a total amount of about 1500 mgm per day. An additional extra-cellular matrix (ECM), Heparan Sulfate, a highly sulfated, and highly anionic, ECM, compound is bio chemically equivalent to the basement membrane (ECM) of the filter mechanism of the kidney.

This therapeutics is used to avert the need for renal transplantation. The patient will also able to use reduced levels of anti rejection medication (such as corticosteroids, macrolides, and cyclosporin) and thereby reduce the onerous side effects from these medications. The therapy can also be administered before, during, and after renal transplant to aid in preventing organ rejection.

Case 3. Corneal Transplantation

Patients requiring corneal transplants are prescribed five, 390 mgm capsules, given 3 times daily of a therapeutic formulation comprising of the following to mimic cyclosporin: 4 moles L leucine, 2 moles L alanine, 2 moles L valine, 1 mole gamma amino butyric acid, one mole methionine, one mole betaine, and one mole glycine. The formulation further comprises linolenic acid and phospholipids. The therapy is used for the patient's lifetime to minimize risk of corneal rejection.

Case 4. Kidney Damage

A patient needing kidney transplantation is prescribed a 390 mg capsule comprising L amino acids, linolenic acid, EPA (about 0.3 to 0.5 g per day), and phospholipids. The prescription is administered as 1 to 5 capsules, 3 times daily. The amino acid components are present as essential L amino acids in the molar ratio found in healthy kidney protein.

Case. 5 Kidney Failure A patient needing a kidney transplant receives the therapy of the invention. Five 390 mgm capsules are given 3times daily of a formulation comprising linolenic acid, phospholipids, and essential amino acids in the following ratio to mimic cyclosporin: four moles L leucine, two moles L alanine, two moles L valine, one mole methionine, one mole gamma butyric acid, one mole betaine and one mole glycine.

Case 6. Corneal Transplant

A patient receives a corneal transplant. The patient is prescribed 390 mgm capsules to be taken 3 times daily of a composition comprising linolenic acid, phospholipids, and L amino acids. The L amino acids and their molar ratios are determined based upon a chemical analysis of healthy lens tissue and the diseased lens tissue removed.

Case 7. Chronic Inflammatory Bowel Disease (Regional Ileitus)

A 68 year-old female patient was diagnosed with Crohn's disease (also known as regional ileitus). The diagnosis was made by small bowel barium x-ray. Diagnosis had also been made by surgical removal of seven inches of terminal ileum twenty years ago. The patient received Neocate.TM. in the form of 5 capsules containing 390 milligrams each, 3 times daily. This was preceded by a course of 155 milligrams of Omega 3 eicosapentanoic acid lipid and 125 mg DHA administered 3 times a week for 2 weeks. The patient had an excellent response with no symptom flare-ups. The absence of side effects is attributable to the therapy, and the ability to avoid increasing the dosage of corticosteroids. The patient continued to receive triamcinolone acetate 4 milligrams daily before, during, and after the inventive therapy. In contrast, the patient had needed triamcinolone acetate dosage increases as frequently as every 3 to 4 weeks before the inventive therapy was administered. After treatment with the inventive therapy, the patient was able to reduce her average daily corticosteroid dosage by a half. Furthermore, flare-ups were reduced. Thus, the severity of corticosteroid side-effects, such as ecchymoses and bruising, were greatly minimized. The unpleasant taste of the therapeutic compositions was overcome by formulating as capsules. Before meals, 5 capsules of the therapeutic formulation were ingested to allow relief from the extreme discomfort resulting from ingesting dairy products and beef.

Case 8 The patient of Case 7 had the commonly seen complications of long term corticosteroid use, such as recurrent and excessive bruising, particularly of the arms and hands, and difficulty of healing from the mildest trauma. Additional therapy of vitamin K (Mephyton 5 mgm) 4 tablets daily was prescribed. An ointment of Neocate (390 mgm), zinc oxide and vitamin E was prepared, and applied topically to bruises daily with a pressure dressing on any lacerations to accelerate healing.

Case 9

The patient of Case 3 receives the prescribed formulation in the form of ophthalmic preparations in 0.1%, 1.0%. or 5.0% solutions in buffered saline, 1 to 3 drops administered 2 to 3 times daily. Lifetime usage is prescribed.

Case 10. Arthritis

A female patient, age 45, was diagnosed with traumatic arthritis of the left knee. No response was shown to non-steroidal, anti-inflammatory medications. For a limp associated with the arthritis, she was prescribed 740 mg capsules, 3 times daily of chondroitin sulfate collagen cartilage (shark source). After several months of therapy, she has greatly improved and almost free of symptoms. Her chronic bronchitis (which had not responded to a three to four week course of antibiotics) greatly improved in 1 to 2 days and cleared in 1 or 2 weeks when the cartilage dosage described in this case was tripled. The following cases and case groups:

Comparative cell biology studies, since these patent filings, include controls and clinical documentation of diseases of poor or guarded prognosis, totaling 247 patients, 27 of which were equine veterinarian, successful large animal studies. This is inclusive of 70 in- vitro cancer studies, all responsive to subject composition therapeutics that mimic human tissue and is derived from equivalent bio-chemical therapeutics components of FDA pre- approved-as-safe.

Preclinical documentation including comparative cell biology controls and clinical documentation of therapeutic sub composition, detailed in examples starting with example 11.

Case Group 11. of surgical prc-operative care

About 100 surgical cases with comparative controls Intravenous administration in the first 100 surgical patients:

We found acceleration of postoperative recovery wherein the 'B' surgical service patients were able to be discharged a few days earlier than the 'A' surgical service patients.

This amino nutrient intravenous Amigen 250 to 500 ml with ascorbic acid about 250 mg (Mead Johnson, Evansville IL) by therapeutics initiated preoperatively and continued operatively and post operatively stimulated protein synthesis so essential to anabolic healing.

This beneficial effect was also seen in the first child, age 12, female, with heart disease, to benefit from the innovation of the heart lung machine, prior use included only 1 other adult patient. Discharge of patients was hastened and the postoperative prognosis was significantly improved.

Case Group 12. Immunologic Diseases: Allergy, Asthma and Autoimmune Disease

Therapeutic oral outpatient administration in immunology and allergy care of 30 allergic and asthmatic patients resulted in rapid recovery that more than satisfied Nutramigen a free amino acid formulation prepared by acid hydrolysis of cow's milk hydrolyzed, Nutramigen Hypoallergenic Protein Hydrolysate Formula, Evansville, Indiana, 1 packed level scoop per 2 fluid ounces, 4 to 6 ounces, 3 to 4 times daily, was used as a milk substitute where milk allergy was clinically suspected even though the skin test was negative. Patient's response of complete reversal of allergic disease, allergic rhinitis and asthma was out of proportion to the suspected milk allergy and appeared to be the healing mechanism as seen with foregoing Amigen subject composition therapeutics of amino acids, vitamins (minerals included herein in this infant formulation).

This was illustrated again, in a severe drag reaction patient with false lupus. Characteristic findings of pericardial effusion were diagnosed by ultrasound, chest x-ray and abnormal anti-nuclear antibody titer of 1 to 2600, characteristic of false lupus erythematosis (pericardial involvement is present in 60% of false lupus erythematosis in contrast to about a 10% incidence in true lupus erythematosis), all precipitated by the unusual reaction to an antibiotic. These pericardial effusion findings and laboratory findings cleared in three weeks with a variant of the foregoing therapeutics. The treatment included Cartilade 4 to 5 capsules. 3 times daily (Cartilade, Ontario, Canada, formerly BioTherapies, Inc., Fairfield NJ.).

Case 13. Pericardial Effusion, Auto-immune Immunologic Disease A 70 year old male was diagnosed by cardiac ultrasound, and chest x-ray, with pericardial effusion (an autoimmune reaction). He was prescribed a three week regime of the antibiotic Biaxin (500 mg tablet twice daily for persistent bronchitis, Abbott Laboratories, Chicago, 111.). He was also diagnosed with a false lupus autoimmune reaction to the antibiotic. The patient was removed from all other medications and received the following therapy: cartilage in the form of Cartilade, three 740 mg capsules, 3 times daily; EPA, 360 mg capsules once daily; an Omega-3 anti-inflammatory fatty acids. In three weeks, his fever and fatigue lessened. His blood sedimentation rate improved dramatically from 75 mm per hour to a normal of 15. His antinuclear antibody (ANA) titer also greatly improved to 1 dilution titer above normal (1 :320). His chest x-ray and ultrasound showed no pericardial effusion. The increase in sedimentation rate as a time honored index of disease as thermometry. This rapid fall in red blood cell sedimentation of 15mm per hour to 75mm per hour in this case is associated with an increase in immunoglobulin 1-2600 his antinuclear antibody (ANA) titer as well as an increase in fibrinogen which responds to the stimulus of healing, protein synthesis activation of templating and the metabolic cell cycle providing not only essential protoplasmic protein but also essential enzymes such as DNA and RNA polymerase that provide the cytoplasm normalization and enhancement of genomic nuclear expression and anti-inflammation that further include stimulation of the normal protein enzyme necessary for apoptosis homeostatic modulation of the body's cell population and normalization of metastasis also a complication of persistent, aggressive inflammation predisposition in the case of cancer. More recently in the case of obesity felt through the same mechanism to normalize homeostatic modulation of the body's cell population provided by the bio-materials of subject composition with maximized and optimized efficacy and safety when presented as therapeutic synergistic composition chemical claims such as 6,974,796 Bl . This is a case in all components exemplified herein.

In cases that fail to heal (Part II page 13 of failure to heal secondary to steroids and/or NSAID) are commonly associated with reduced of serum albumin levels associated with malnutrition inflammation and serious liver and renal disease. Which responds to the stimulus of healing, protein synthesis activation of templating and the metabolic cell cycle providing not only essential protoplasmic protein but also essential enzymes such as DNA and RNA polymerase that provide the cytoplasm normalization and enhancement of genomic nuclear expression and anti-inflammation that further include stimulation of the normal protein enzyme necessary for apoptosis? In the case of healing a wound that failed to heal with subject composition we have found a significant decrease in the need for debridement and normalization of metastasis predisposition in the case of cancer in homeostatic modulation of the body's cell population. More recently in the case of obesity felt through the same mechanism to normalize homeostatic modulation of the body's cell population provided by the bio-materials of subject composition with maximized and optimized efficacy and safety when presented as therapeutic synergistic composition chemical claims such as 6,974,796 Bl. This is a case in all components exemplified herein.

Case Group 14. Arthritic Musculoskeletal Diseases, intractable and not responsive to prior therapy Therapeutic oral and local administration application to intractable and not responsive to prior therapy, of arthritic musculoskeletal diseases pilot study of 13 patients of therapeutic subject composition mimicking human tissue and derived from components of FDA pre- approved as safe.

These patients with intractable arthritic musculoskeletal disease include 6 clinical human cases, and 7 pre-clinical large animal equine veterinary tendonitis and synovitis arthritis induced by trauma, not responsive to conventional equine veterinarian management. All seven animals studied and treated completely responded within one to two weeks to subject composition therapeutics topical applications to the joint with complete return of functional activity of the joint. The 6 human cases include non-surgical reversal of the need for prescribed prosthesis.

Case 14 (a.) Knee Replacement

Knee replacement was prescribed for a 65 year old male. He already had a prosthetic knee replacement. The second knee replacement was being scheduled. Surgery was also averted with use of subject composition oral therapeutics. His knee pain and range of motion normalized. This patient progressively responded to subject composition's therapeutic, (topical therapy was not available at the time of initiation of subject composition oral therapeutics). Subject composition therapeutics was administered with some immediate response in the next few months. Over the next several months, noπnalization of range of motion occurred. This treatment consisted of 2 to 3 Shark cartilage capsules 2 to 3 times daily, (Cartilade Ontario, Canada, formerly BioTherapies, Inc., Fairfield NJ.).

Case 14 (b.) Arthritis of the hip joint, averting the knee for hip prosthesis Hip replacement was prescribed for a 45 year old female. She felt she was too young to have the invasive surgical care that was recommended because she was unable to walk without severe pain and limping, and required a cane. Surgery was also averted with use of subject composition therapeutics oral therapeutics. This therapeutics was administered orally 2 to 3 times daily. Her pain and range of motion normalized. This patient progressively responded to subject composition oral therapeutics, (topical therapy was not available at the time of initiation of subject composition oral therapeutics). Subject composition therapeutics was administered with some immediate response in the next 6 months. Over a period of 5 years normalization of the range of hip motion occurred and she is now able to walk 10,000 paces daily without pain, and without the need for any support.

A female patient age 45 was diagnosed in with Rheumatoid Arthritis and Osteoarthritis of the hip. Planning for hip replacement was cancelled in view of the dramatic improvement with normalization of the hip joint. Functionality of the hip joint was normalized, from a hip joint that showed no joint space and a complete arthritic fusion of the hip joint using a variant of this therapeutic subject composition.

Within a year, the patient went from being unable to walk the distance of a block without severe pain in the hip, to 5,000 paces per day. Within the next year she was able to walk 10,000 paces daily pain-free which she has maintained to date. Most recently, she was able to walk 12,000 comfortable, pain-free paces per day. Available to the patient through component supplied by Puritan Pride, Oakdale, New

York (See Table 5)

Case 14. (c.) Bilateral osteo-arthritis

In both knees in a 60 year old male, presented with left knee more involved than the right, associated with pain and limitation of range of motion upon bending, ( of several decades duration). Trauma was a possible contributory factor in triggering the bilateral osteo-arthritis. Within two weeks of onset of treatment, the patient noticed a 50% improvement in pain and limitation of motion, and approximately a 50% reduction in associated symptoms and signs of swelling and fluid collection in the left knee. The treatment included Neocate (SHS International Liverpool UK) 1 teaspoon added to 3 ounces of spring water, shaken well to emulsify 1 to 3 times daily; phospholipid phosphatidyl choline, (Carlton Laboratories, Arlington Heights, IL) 1 capsule 3 times daily; Glucosamine sulfate, Chondroitin sulfate, MSM (the Vitamin Shoppe North Bergen, NJ or Now Foods, Bloomingdale, IL); VitaCarte (Phoenix Biologies, Vista California Vita Cart Chondroitin sulfate 750 mg per 4, type 2 collagen was 720 mg per capsule 3 to 4 times daily) 1.2 g of phosphatidyl choline complex (400 mg phosphatidyl, 56 mg choline 2 to 3 times daily); essential lipids Norwegian Salmon Oil 1 g capsule of Omega 3 EPA and DAJ (2 capsules, 2 to 3 times daily).

Bilateral osteo-arthritis of the knee joints. Male age 60, had a knee replacement and was awaiting scheduling for a second knee replacement. With the addition of Cartilade (Ontario, Canada, formerly BioTherapies, Inc., Fairfield NJ.) he progressively improved over several months, averting the need for prosthetic knee replacement.

Case 14. (d.) Rotator cuff tear

2 male patients, age 56, and age 80, had surgical care averted with the use of subject composition therapeutic lotion applied topically to the affected area. Diagnosis was confirmed clinically by examinations which also included an MRI examination in one patient.

Symptoms of pain and weakness in abduction of the left arm and forearm (Movement by the patient, abduction, of upper extremity 90 degree angle away from the body). Diagnoses of both patients' were confirmed by orthopedic examination. The first patient's diagnosis was also confirmed by nuclear magnetic resonance examination. Patients progressively improved over a period of three to four weeks. Symptomatic improvement was noted in regard to pain reduction, within five to ten minutes after local application in the medication included no analgesic.

However, most significant relief was noted after about 1 week when Neocate (SHS International, Liverpool UK, now available through Nutricia Gaithersburg, MD) was added. Progressive improvement was noted and the orthopedic surgeon felt that surgery that was being considered was no longer required.

Dosages are:

-about 1 to 2 tablespoons Glucosamine Chondroitin MSM Cream (Nature's Plus, Melville, NY) - about 1 to 2 tablespoons Vitamin A&D Zinc Oxide Cream (Schering-Plough

Healthcare Products, Inc, Memphis, TN)

- about 1 to 2 tablespoons Vitamin E Cream (Jason Natural Products, Culver City, CA) - about 1 to2 capsules Branched Chain Amino Acids — Valine, Leucine & Isoleucine (Life Extensions, Ft. Lauderdale, FL)

- about VA to ½ teaspoon de-oiled Soy Lecithin Powder (Solec, St. Louis, MO) or 1,200 mg lecithin capsules containing 400 mg Phosphatidyl Choline (Carlson Laboratories, Arlington Heights, IL)

- about 2 to 3 times daily applied Heating Pad after local application.

*Later added the following, therapeutic response was not noted until this addition to the lotion which was made after about 1 week of use: -Neocate (SHS International Ltd., Liverpool, UK) 1 teaspoon in addition to one capsule of branched chain amino acids Life Extension and Ft. Lauderdale Florida, stirred well in the foregoing well mixed formulation

Additionally noteworthy therapeutic response resulted in the patient age 80 who also had a fungal infection in the right medial corner of his middle finger nail and nail bed (ungual tinea infection) which was persistent for several months. The foregoing transdermal topical lotion cream (fortunately but initially unintentionally applied as a therapeutic focus) included in application was applied to this area while applying it to the left arm torn rotator cuff area as described above. The nail returned to normal in a few weeks, with normal re-growth of the finger nail. Since unintentional and inadvertent initially, this might be looked upon as a valiant of the blind therapeutic application with clinical response of chronic fungal (tinea) otherwise unresponsive to prior treatment.

The healing anti-inflammatory activity of subject composition therapeutic topical lotion was dramatized with its successful local use in the above 2 male patients with rotator cuff tear. Surgical care was averted with the use of therapeutic subject composition of matter lotion applied topically to the point of maximum tenderness of the affected shoulder.

Diagnosis was confirmed clinically by orthopedic examinations which also included an MRI examination.

Case Group 15. Therapeutic use of therapeutic subject composition transdermal immunotherapeutic anti-inflammatory healing lotion in equine veterinary animal care for Tenosynovitis, tendonitis, traumatic arthritis, and therapeutic response

It was this therapeutic success in the torn rotator cuff in the humans that prompted similar successful local topical therapeutic subject composition of matter lotion application with complete recovery in Equine Veterinary care. (Most recently reported) when used in 27 total equine veterinarian cases of disabled horses due to tendonitis, tendosynovitis and traumatic arthritis.

It was this therapeutic success that prompted similar successful local, transdermal, topical lotion application, use in the 27 cases of equine veterinarian arthritis and tendosynovitis. The horses legs were shaved, covered with the lotion application, and saran wrapped so that the animal would not rub off the lotion. In one case, the skin had been completely avulsed, (traumatically torn away). This case was covered with the amnion as part of the equine embryonic cell mass, instead of saran wrap. This work with the equine veterinarian included therapeutic subject composition of matter lotion, local application with traumatic arthritis and tendosynovitis that further included reversal of the extensive areas of damaged skin (that had been traumatically avulsed). All cases were not responsive prior to current therapy. To quote the equine veterinarian, 100% efficacy was achieved with this therapeutic subject composition of matter whereas the most advanced equine veterinarian therapeutics was not effective.

Formulation ratios and amounts to provide a final transdermal delivery system lotion product with dosage for humans is about ¼ to ½ teaspoon, applied locally to the skin in the horses, the dosage is 4 to 8 times greater because of their increased six fold weight over humans and an increased surface area and tissue area for transdermal absorption, and penetrants to subjacent tissues, and disease reversal:

-about 1 to 2 tablespoons Glucosamine Chondroitin MSM Cream (Nature's Plus, Melville, NY)

- about 1 to 2 tablespoons Vitamin A&D Zinc Oxide Cream (Schering-Plough Healthcare Products, Inc, Memphis, TN) -about 1 to 2 tablespoons Vitamin E Cream (Jason Natural Products, Culver City, CA)

-about 1 to 2 capsules Branched Chain Amino Acids — Valine, Leucine & Isoleucine (Life Extensions. Ft. Lauderdale, FL)

-about ¹A to ½ teaspoon de-oiled Soy Lecithin Powder (Solec, St. Louis, MO) or 1,200 mg lecithin capsules containing 400 mg Phosphatidyl Choline (Carlson Laboratories, Arlington Heights, IL)

-2 to 3 times daily applied Heating Pad after local application -Neocate (SHS International Ltd., Liverpool, UK) 1 teaspoon in addition to one capsule of branched chain amino acids Life Extension and Ft. Lauderdale Florida, stirred well in the foregoing well mixed formulation

- about 1 to 2 tablespoons MSM Liposome Lotion (Now Foods Bloomingdale, IL) this has been added to further synergize the healing protein synthesis, anti-inflammatory therapeutics applied to torn rotator cuff as well as the musculoskeletal therapeutics applied to Equine veterinary medicine.

This also provides a methodology for drug discovery by co-using in the therapeutics of an existing veterinarian disease. At the same time, this represents a method of drug discovery in animal testing with use in an existing analog disease model. This was accomplished without experimentally producing a disease model in an animal, representing an ethical and humane advance in drug discovery as well as a significant economic advantage in greatly minimizing the costs that are escalating in drug development by accomplishing two beneficial therapeutic effects at the same time. Case 16 Cervical musculoskeletal strain

These veterinary case observations and lotion therapeutic advances were further used in medical care of female, age 76, awakened from sleep with acute cervical musculoskeletal strain and arthritis. She responded after topical application of subject composition therapeutics. After treatment she was symptom free of pain with full range of cervical motion normalization upon awakening the next morning. This transdeπnal immunotherapeutics, antiinflammatory, tissue healing, activation of the patient's own stem cell subject composition lotion, locally applied to the painful neck muscles 2 to 3 times daily, included:

-about 1 to 2 tablespoons Glucosamine Chondroitin MSM Cream (Nature's Plus, Melville. NY) - about 1 to 2 tablespoons Vitamin A&D Zinc Oxide Cream (Schering-Plough

Healthcare Products, Inc, Memphis, TN)

-about 1 to 2 tablespoons Vitamin E Cream (Jason Natural Products, Culver City, CA) -about 1 to 2 capsules Branched Chain Amino Acids — Valine, Leucine & Isoleucine (Life Extensions, Ft. Lauderdale, FL) -about ¹A to ½ teaspoon de-oiled Soy Lecithin Powder (Solec, St. Louis, MO) or 1 ,200 mg lecithin capsules containing 400 mg Phosphatidyl Choline (Carlson Laboratories, Arlington Heights, IL)

-2 to 3 times daily applied Heating Pad after local application -Neocate (SHS International Ltd., Liveφool, UK) 1 teaspoon in addition to one capsule of branched chain amino acids Life Extension and Ft. Lauderdale Florida, stirred well in the foregoing well mixed formulation

- about 1 to 2 tablespoons MSM Liposome Lotion (Now Foods Bloomingdale, IL) this has been added to further syncrgize the healing protein synthesis, anti-inflammatory therapeutics applied to torn rotator cuff as well as the musculoskeletal therapeutics applied to Equine veterinary medicine.

Case 17 Plantar fascial inflammation in a female adult patient This acute musculoskeletal strain and severe foot pain occurred when getting out of bed, and standing with bare feet. The strain was associated with extensive standing and walking without her customary shoe arch support. With the use of the foregoing lotion application and soak supplied for the acute gout arthritis was followed by progressive improvement over a 1 week period. The use of Advil liquid filled capsules solubilized ibuprofen locally added to the transdermal cream expedited the reversal of acute gout after one - two applications. This was administered by emptying the Advil liquid filled capsules onto the acute gout arthritis resulted in the reversal of the gout inflammation after a few applications. The orally administered treatment further included therapeutic subject composition extra-cellular matrix components chondroitin sulfate, glucosamine sulfate, MSM 2 to 3 capsules, 3 times daily; Vita Carte Bovine Cartilage, (Phoenix Biologies Vista, CA) 4 capsules, 3 times daily ; Cartilade shark cartilage, (Ontario, Canada, formerly BioTherapies, Inc., Fairfield NJ.) 4 capsules 3 times daily, was also added to allay the severe discomfort (Now Foods Bloomingdale, IL); Neocate (Neocate infant foπnula SHS Liverpool, UK and Nutritia Gaithersburg, MD) 1 to 2 teaspoons emulsified in 3 ounces of spring water daily ; and phospholipid phosphatidyl choline 1.2 grams, 3 times daily (Carlson Laboratories, Arlington Heights, IL)The pain was so severe that she felt that a narcotic (such as codeine) would be necessary, however, using 2 Bufferin (GlaxoSmithKline Research Triangle Park, NC) functioned synergistically with complete relief of pain, obviating the need for any major pain medication. The patient was also treated with this transdermal immunotherapeutics, antiinflammatory, tissue healing, activation of the patient's own stem cell subject composition lotion, locally applied to the sole of the foot 2 to 3 times daily, included: -about 1 to 2 tablespoons Glucosamine Chondroitin MSM Cream (Nature's Plus, Melville, NY)

- about 1 to 2 tablespoons Vitamin A&D Zinc Oxide Cream (Schering-Plough Healthcare Products, Inc, Memphis. TN) -about 1 to 2 tablespoons Vitamin E Cream (Jason Natural Products, Culver City, CA)

-about ¼ to ½ teaspoon de-oiled Soy Lecithin Powder (Solec, St. Louis, MO) or 1,200 mg lecithin capsules containing 400 mg Phosphatidyl Choline (Carlson Laboratories, Arlington Heights, IL)

-2 to 3 times daily applied Heating Pad after local application

-Neocate (SHS International Ltd., Liverpool, UK) 1 teaspoon in addition to one capsule of branched chain amino acids Life Extension and Ft. Lauderdale Florida, stirred well in the foregoing well mixed formulation - about 1 to 2 tablespoons MSM Liposome Lotion (Now Foods Bloomingdale, IL) this has been added to further synergize the healing protein synthesis, anti-inflammatory therapeutics applied to torn rotator cuff as well as the musculoskeletal therapeutics applied to Equine veterinary medicine.

Case 18 Neurologic disease: Hearing Loss in aging

A 76 year old female patient with neuro-sensory hearing loss, documented by audiologic studies. She responded in 24 hours to improvement in hearing loss. She was given 1 capsule containing Choline 250 mg; and Inositol, 250 mg (Now Foods, Bloomingdale, IL) 3 times daily. Her hearing improved in that she was now able to hear when someone spoke behind her and additionally she was able to hear the whispered voice. These findings were observed without the use of her hearing aid. Her hearing was augmented to some degree by her hearing aid. Her prior management with hearing aid was not reliably effective. This was also felt to be able to augment the effects of phosphatidyl serine; 100 mg, 3 times daily, which was of value in helping her occasional memory loss functionality. This treatment was added to the subject composition therapeutics of her Crohn's disease, as a continuation of therapy illustrated in Case 24 and is included in its entirety by reference (p. 83 through p. 90). Hearing loss, associated with the neυro catabolic factors of aging, and use of Choline and Inositol have been added to therapeutic subject composition to help advance the care of neurologic disease, as in neuro-sensory hearing loss.

This memory loss recurred and significantly improved: by the further addition of acetyl L-carnitine (the acetyl form has been noted to be nervous system active in contrast to the non-acetyl form which is helpful in cardiovascular disease) ( Life Extension, Fort Lauderdale, FL or Doctor's Preferred LLC, Potomac MD) 500mg 3-4 times daily. It is felt that this is a most helpful addition. However, another product was also added, PS complex (phosphatidyl serine). It probably is not having a significant effect. In addition, the hydrophilic surfactant affect phosphatidyl choline (Carlson Laboratories, Arlington Heights, IL) 1.2 grams per capsule three times per day. Alpha-GPC (Doctor's Preferred LLC, Potomac MD) a derivative of the phosphatidyl choline 125mg two capsules times per day was also added: Vitamin B 6 38mg Folic Acid 50 meg

Vitamin B 12 25 meg Pantothenic Acid 50mg Alpha-Glycerylphosphorycholine 125mg Green Tea Extract 50mg Blueberry Powder 25mg DMAE 20mg and Vinpocetine 5mg was added to subject composition.

5- methyltetrahydrofolate 1.2 mg daily, is added to subject composition as effective dosage range 0.2 to 1.2 mg daily (5-MTHF, Life Extension, Ft. Lauderdale, FL) a normal bioactive format of folic acid component of mammalian tissue such as human tissue not requiring metabolic conversion nor masking nor obscuring vitamin B 12 detection and being added to enhance memory and mental function and the normalization of the abnormal level of homocysteine (defiant in folic acid or B 12). Also synergistically helpful components of subject composition riboflavin 100 mg daily to twice daily, vitamin B6 50 to lOOmg daily . Catalyzing conversion of homocysteine to normal amino acid L cysteine and then to glutathione, B12 helping to catalyze methylation conversion to essential L methionine. Trimethylglycine (betaine) up to 6 grams daily may be added if necessary to reduce homocysteine. Also applicable in the following cardiac patient. Also is added to subject composition in a male patient early 80's who had border-line abnormal homocysteine of 13 mg% (abnormal level of above 14%) with associated increase in sed-rate to 35 mm/hr and C reactive protein while under cardiac care to prevent future myocardial infarction.

Case 19 Epilepsy

Adolescent, age 16 was treated with phosphatidyl choline, (Carlson Laboratories, Arlington Heights, IL) 1 gram, 2 to 3 times daily, with relief of epileptic seizures. This case provides similar anti-seizure effect that resulted from the use of phospholipid phosphatidyl choline for small animals (dogs and cats). This 16 year old boy was able to find work and not be handicapped by the concerns of epileptic seizures and has remained symptom free of seizures for several years.

Case 20. Neurologic Diseases including Alzheimer's Disease

(1.) A 70 year old patient is treated for progressive memory loss suspected of being Alzheimer's originated with folic acid, 3 capsules, 3 times daily, of 400 mg capsule, (TwinLab Corporation, Hauppauge, NY) Vitamin B- 12, 1 mg (Methyl cobalomine, Jarrow Laboratories Los Angeles, CA) Phosphatidyl serine 100 mg, 3 times daily, 1 capsule containing Choline 250 mg; and Inositol, 250 mg (Now Foods, Bloomingdale, IL) 3 times daily, 1.2 g Phosphatidyl Choline 3 times daily (Carlson Laboratories, Arlington Heights, IL) 1 g Norwegian Salmon Oil, 2 capsules, 3 times daily (Carlson Laboratories Arlington Heights IL), Ascorbic Acid 1 g, 3 times daily (Mead Johnson, Evansville IL); Bovine Cartilage 4 capsules, 3 times daily (Phoenix Biologies, Vista, California) Glucosamine and Chondroitin sulfate, 2 to 3 capsules, 3 times daily (Now Foods, Bloomingdale, IL) Neocate (SHS International Ltd., Liverpool, UK, also Nutricia, Gaithersburg, MD) 1 to 3 teaspoon, 3 times daily; Vitamin B-50 complex, 1 tablet, 2 times daily (Sundown Incorporated, Boca Raton, FL).

This patient's therapeutics, and clinical course, will also be tracked, preferably before treatment and clinical course follow up with the following cognitive laboratory tests: with homocysteine levels, as well as a test for abnormally high methylmalonic acid blood levels, an indication of deficiency in B-12. If abnormal, vitamin B-6, and folic acid will also be tested. This is with particular reference to psycho geriatric cases in that B-12 and folic acid deficiencies have been commonly found, however dementia has not been noted without a reduced level of folic acid. These reduced levels have also been the case with Parkinson's disease patients, with even higher homocysteine levels (an index of the dysmetabolic 3-D stereo mismatch and misfit of homocysteine in contrast to its normal isomer form of methionine and or cysteine). These amino acids are essential to satisfy the amino aid molar ratios, specified by the genetic code of targeted neuro proteins. Therefore, this treatment would be applicable to (2.) patient with Parkinsonism is treated as well with the foregoing therapeutics.

(3.) Treatment of Schizophrenia. The foregoing treatment and clinical course tracking system, is also applicable and is used in a patient diagnosed as schizophrenic with characteristic delusional hallucinations and age of onset, late teens and 20s, since homocysteine levels have been found to be abnormally high in schizophrenia. Also, since the dopamine hypothesis of schizophrenia has been dominant, the tryptophan is to be added, 500 mg at bed time. This may be repeated 1 to 2 times daily if it is not found to be soporific. Additionally, intestinal permeability studies should be done to rule out a predisposing factor of poor intestinal absorption celiac disease. The foregoing amino acids as in therapeutic subject composition, should be helpful in reversing abnormal permeability, a contributory factor to some cases of schizophrenia. Celiac disease, treatment also includes avoidance of gliadin, present in wheat and other grains except for rice and corn. Rice and corn do not activate Celiac Disease. These patients have high serum antibodies to gliadin and other food proteins, probably secondary to increased permeability which is a result of enteropathy produced by T cell defects. The B cell immune complexes of antibody plus gliadin also contribute to the enteropathy. Through B cell antibody dependency and some mediated cytotoxicity, and activation of complement. Psychiatric disturbances, such as schizophrenia are associated with this intestinal immunologic defect which, if found must also be treated (Amenable to amino acid therapy as part of subject therapeutic composition).

It is important to note here that neurologic diseases such as schizophrenia can be triggered by dental anesthesia nitrous oxide. (Cautious use in genetic treatment if there is a pattern of schizophrenia). This concern is more specifically applicable in, multiple sclerosis cases, but further more specifically applicable to Vitamin B-12 deficiency. As we have noted before, it is a common co factor with folic acid in patients with Dementia.

Case 21. Treatment of Burns A female patient age 49 accidentally scalded her hand with very hot coffee resulting in a third degree burn about linch in diameter. This progressively healed over a period of 2 to 3 weeks without any scarring with the use of the following transdermal anti-inflammatory activation of healing immunotherapeutics lotion. Formulation ratios and amounts to provide a final transdermal delivery system lotion product with dosage for humans is about !4 to ½ teaspoon, applied locally to the skin, for transdermal absorption, and penetration to subjacent tissues, and damaged tissue reversal was prepared as follows:

-about 1 to 2 tablespoons Vitamin A&D Zinc Oxide Cream (Schering-Plough Healthcare Products, Inc, Memphis, TN)

-about 1 to 2 tablespoons Vitamin E Cream (Jason Natural Products, Culver City, CA) -about 1 to 2 capsules Branched Chain Amino Acids — Valine, Leucine & lsoleucine (Life Extensions, Ft. Lauderdale, FL)

-about % to ½ teaspoon de-oiled Soy Lecithin Powder (Solec, St. Louis, MO) or 1,200 mg lecithin capsules containing 400 mg Phosphatidyl Choline (Carlson Laboratories, Arlington Heights, IL)

- about 1 to 2 tablespoons MSM Liposome Lotion (Now Foods Bloomingdale, IL) this has been added to further synergize the healing protein synthesis, anti -inflammatory therapeutics applied to torn rotator cuff as well as the musculoskeletal therapeutics applied to Equine veterinary medicine.

Case Group 22. New Drug Discovery

(1.) This also provides formulation examples as well as a methodology for drug discovery by co-using in the therapeutics of an existing veterinary disease. At the same time, this represents a method of drug discovery in animal testing with use in an existing analog disease model. This was accomplished without experimentally producing a disease model in an animal. This represents an ethical and humane advance in drug discovery, as well as a significant economic advantage in greatly minimizing the costs that are escalating in drug development by accomplishing two beneficial therapeutic effects at the same time.* The advantage is healing an animal requiring, and unresponsive to existing veterinary therapeutics, in contrast to reproducing the disease in the experimental animal, with the advantages cited above.* This is further exemplified by use of transdermal immunotherapeutic anti-inflammatory healing lotion based on therapeutic success and averting the need for surgery in human use, two patients with torn rotator cuffs. Another principle to follow is this 3-D stereo chemical fit, to prevent misfit can be further conceptualized in terms of the resulting from this misfit in the form of metabolic intolerance that we have progressively discovered in regard to trans-fatty acid fats a product of hydrogenation design based on 2-D chemistry. As a result this clinical medicine 3-D stereo chemical misfit acting as a biochemical molecular foreign body was originally mandated to be removed from the marketplace by the country of Denmark make great strides in food chemistry and hand through their leadership has been taken off the market throughout the world.

This 3-D fit represents a biologic model that was utilized in another biologic model of mimicking human tissue, and mammalian, such as human tissue's healing capacity. Therefore, to accomplish these 3-D integrative biologic fits, this may best be sourced by FDA pre-approved-as-sqfe components. These 3-D integrative biologic fits arc derived from such as, but not limited to, plant, animal, and synthetic sources as long as a 3-D integrative biologic fit is maintained, such as the L amino acid and glycine used in subject composition therapeutics. Additionally, microorganism sources are used, all with the precaution of avoidance of catabolic bio-chcmicals such as, but not limited to, lactic acid bacteria pro- biotics. Formulation ratios and amounts to provide a final transdermal delivery system lotion product with dosage for humans is about ¼ to ½ teaspoon, applied locally to the skin in the horses, the dosage is 4 to 8 times greater because of their increased six fold weight over humans and an increased surface area and tissue area for transdermal absorption, and penetrants to subjacent tissues, and disease reversal: -about 1 to 2 tablespoons Glucosamine Chondroitin MSM Cream (Nature's Plus,

Melville, NY)

- about 1 to 2 tablespoons Vitamin A&D Zinc Oxide Cream (Schering-Plough Healthcare Products, Inc, Memphis, TN) -about 1 to 2 tablespoons Vitamin E Cream (Jason Natural Products, Culver City, CA) -about 1 to 2 capsules Branched Chain Amino Acids — Valine, Leucine & Isoleucine (Life Extensions, Ft. Lauderdale, FL)

-2 to 3 times daily applied Heating Pad after local application

-Neocate (SHS International Ltd., Liverpool, UK) 1 teaspoon in addition to one capsule of branched chain amino acids Life Extension and Ft. Lauderdale Florida, stirred well in the foregoing well mixed formulation

- about 1 to 2 tablespoons MSM Liposome Lotion (Now Foods Bloomingdale, IL) this has been added to further synergize the healing protein synthesis, anti-inflammatory therapeutics applied to torn rotator cuff as well as the musculoskeletal therapeutics applied to Equine veterinary medicine. (2.) Most importantly, our providing cell biology and analog models to enables this therapeutic subject composition of matter to reverse the significant therapeutic challenge of diseases of poor prognosis. This example of cell model and analog models can best be illustrated by: therapeutics composition of matter in reversing cancer in- vitro and in- vivo.

(3.) Example of an anticancer therapeutics cell biology model and basis for therapeutic advance in treatment: The initial study of comparative microscopy of the remarkably similar configuration of the characteristic cell of cancer with the lipophilic micelle liquid crystal configuration when adjacently placed for comparative study. It is believed this colloidal emulsion technology domain, structural geometric, microscopic, configuration that the foregoing lipophilic micelle and characteristic cell of cancer shares functional biophysical colloidal emulsion technology parameters. These commonalities appear to offer a cell and micelle biology therapeutic opportunities in reversing and normalizing the enigma of cancer tissue and its clinical consequences.

The analog cell biology model for the pharmacodynamics and pharmacologic basis for this unique application is exemplified as shown on Diagram 1, Figure 1, on page 37. Example of an anticancer therapeutics cell biology model and basis for therapeutic advance in treatment: The initial study of comparative microscopy of (1.) remarkably similar configuration of the characteristic cell of cancer with the lipophilic micelle liquid crystal configuration when adjacently placed for comparative study. It is believed this colloidal emulsion technology domain structural, geometric, microscopic, configuration that the foregoing lipophilic micelle and characteristic cell of cancer phase; they also share (2.) functional biophysical colloidal emulsion technology parameters. These commonalities appear to offer a cell and micelle biology therapeutic opportunity in reversing and normalizing the enigma of cancer tissue and its clinical consequences.

The therapeutic concept of reversing the highly lipophilic functionality to a progressively more obverse hydrophilic colloidal emulsion technology state provided a therapeutic working model to study this significant therapeutic potential opportunity in-vitro and in-vivo. Additionally, the colloidal emulsion technology biophysical parameters illustrated in diagram 1 , figure 1, were found useful to direct successful therapy in a disease with formerly very pessimistic poor prognosis therapeutic opportunities. This has been further established providing the selectivity potential for a non invasive therapeutics to enhance the therapeutic response and prognosis in diseases that now include cancer.

(4.) In addition, the essential analog cell biology model required for drug discovery, is shown here Of 70 studies of the foregoing 247 clinical and preclinical studies, representing 44 bio-chemicals, 27 and (12 of 44) dramatized a 3-D bio-chemical trend. This trend is also computerizable and provides positive therapeutic results, killing in excess of 88% of cancer tissue within 24 to 48 hours. Five (5) of these studies demonstrated a cancer cell kill rate of 99% to 100% in the same time frame. This is particularly noteworthy since these results were achieved using FDA pre-approved-as-safe components comprising I subject composition therapeutics synthetic cell-like micro-environment therapeutics.

The foregoing is statistically significant, since the current technology of early stage drug discovery utilizes comparative biochemical structures and through computer search commonly requiring 3 million studies so that 1 chemical might be found. If we add the criteria of drug discovery used in the development of this composition of matter into the computer search, the yield would be even significantly less. For example, to achieve this degree of safety, another computer search would have to be superimposed. This would further include a track record of safety over several decades as in this subject composition of matter. Therefore the yield of available compounds would be significantly lessened even more so. If the criteria of the computer search further included simultaneously mimicking human tissue and immunologic 'self as biochemical equivalents of human tissue and its micronutrient and microenvironment of immunologic self, this would even further lessen the yield of potential new compounds. (5.) This progression of filed and issued patents provide a cell biology matrix with self validating mechanisms of the healing process of the synthetic cell-like microenvironment that industry can build upon through further practicing and advancing this patent. The pharmaceutical industry may benefit from this advantageous position by developing and utilizing therapeutic products thereof. At the same time, the pharmaceutical industry will still find themselves within the fundamental scope and chemical infrastructure of the matrix of cell biology mediating healing and disease reversal.

Case 23. Therapeutic Subject Composition Care of Dermatologic Fungal Infection Concurrent with treatment of torn rotator cuff, the following therapeutic dermatologic response was noted in reversing to normal a chronic fungal infection of the finger nail.

Noteworthy, is the therapeutic response in the patient age 80, who also had a persistent fungal infection of several months duration, in the right medial corner of his middle finger nail and nail bed (ungual tinea infection). The treated area (fortunately but initially unintentionally included in application to this area while applying the foregoing to the right arm torn rotator cuff area of damaged tissue) returned to normal in a few weeks, with normal re-growth of nail. Since unintentional and inadvertent initially, this might be looked upon as a variant of a blind therapeutic application with clinical response to chronic fungal (tinea), otherwise unresponsive to treatment. The healing anti-inflammatory activity of subject composition therapeutic topical lotion was dramatized with its successful local use in the above 2 male patients with rotator cuff tear. Surgical care was averted with the use of therapeutic subject composition of matter lotion applied topically to the point of maximum tenderness of the affected shoulder. Diagnosis was confirmed clinically by orthopedic examinations which also included an MRl examination.

Subject Therapeutic Composition was as follows: applied topically to the area of maximal tenderness of the rotator cuff.

- about 1 to 2 tablespoons Glucosamine Chondroitin MSM Cream (Nature's Plus, Melville, NY) - about 1 to 2 tablespoons Vitamin A&D Zinc Oxide Cream (Schering-Plough

Healthcare Products, Inc, Memphis, TN)

- about ¼ to ½ teaspoon de-oiled Soy Lecithin Powder (Solec, St. Louis, MO) or 1,200 mg lecithin capsules containing 400 mg Phosphatidyl Choline (Carlson Laboratories, Arlington Heights. IL)

- about 2 to 3 times daily applied Heating Pad after local application

-Neocate (SHS International Ltd., Liverpool, UK) 1 teaspoon in addition to one capsule of branched chain amino acids Life Extension and Ft. Lauderdale Florida, stirred well in the foregoing well mixed formulation - about 1 to 2 table spoons MSM Liposome Lotion (Now Foods Bloomingdale, IL) this has been added to further synergize the healing protein synthesis, anti-inflammatory therapeutics applied to torn rotator cuff as well as the musculoskeletal therapeutics applied to Equine veterinary medicine.

It was these 2 therapeutic successful responses of the torn rotator cuff, and dermatologic reversal of chronic fungal infection of the finger nail ,that prompted similar successful local, topical, use in the 27 cases of equine veterinarian arthritis and tenosynovitis. The horses legs were shaved, covered the lotion application and saran wrapped so that the animal would not rub off the lotion application. In one case, the skin was completely avulsed, (traumatically torn away) and in this case was covered with the amnion as part of the equine embryonic cell mass, instead of saran wrap.

Case Group 24. Atherosclerosis and Coronary Artery Disease

Four patients treated using subject composition oral therapeutics as a statin substitute, with 25 to 30% decrease in cholesterol resulting. One patient had required angioplasty and a stent for an acute myocardial infarction 7 years prior and with instituting the subject composition therapeutics orally along with topical pre-cordial sternal application to include mammary artery resulted in complete relief of severe fatigue.

Four patients were treated for atherosclerosis and coronary artery disease using subject composition oral therapeutics as a statin substitute with 25 to 30% decrease in cholesterol resulting. The first three patients responded to Norwegian salmon oil (Carlson

Laboratories Arlington Heights IL), 1000 mg of Omega 3 fatty acid fat 2 capsules, 3 times daily. One patient had required angioplasty and a stent for an acute myocardial infarction seven years prior and with reinstituting the subject composition therapeutics orally (Norwegian Salmon Oil, Carlson Laboratories Arlington Heights IL) 1000 mg 2 capsules 3 times daily; along with phosphatidyl choline 400 mg per 1200 mg capsule, 1 capsule 3 times daily; (C-GeI Carlson Laboratories Arlington Heights IL) Vitamin C 1000 mg 1 capsule 1 to 3 times daily; B vitamins particularly B6, folic acid B 12 have helped reduce the homocysteine* blood level from 15mg percent to 1 Omg or less percent (with each reduction in homocysteine of 4mg% there is a decrease by almost 20% in predisposition to coronary artery disease.) B50 Complex Caplets,! tablet twice daily; 50mg each of Thiamine Monohydrate Vitamin Bl ; Riboflavin vitamin B2 (Twin Labs, America Park, UT); Niacin (Niacinamide); 50mg, Vitamin B-6 (Pyridoxine) 50mg, Folic acid 400mcg. B 12 (Cyancobalamin) 50mcg. Biotin 50mcg, Pantothenic Acid 50mg (Sundown Inc.) Pantethine 450mg, 1 daily (Jarrow Formulas, Los Angeles, Ca); Folic Acid 800mcg (Natures Bounty. Bohemia NY); Vitamin B2 (Riboflavin) lOOmg 1 to 2 times daily (Twin Labs, America Park, UT); Selenium Methionine 200mcg (Douglas Laboratories. Pittsburg. PA); Beta Sitosterol 300mg, 163mg of Campesterol, 117mg of Stigmasterol plant sterols to biologically compete with the cholesterol animal sterols(Vitamin Shoppe, North Bergen, NJ); Branched Chain Amino Acid Complex, 300mg of L- Leucine, 150mg of IsoLeucine, 150mg L- Valine, 500mg L-Glutamine, taken as one capsule (Jarrow Formulas, Los Angeles, CA); Quercetin Complex, flavonoid antioxidant preventing flare ups of gout* along with preventing oxidation of low density lipids (LDL) 500mg, Bromelain 50mg, Citrus Bioflavonoids 50mg, Rose Hip 20mg, Acerola 20mg, Rutin 10mg, (Solgar, Leonia, NJ); (Coenzyme Q-10 (Co Q-10) Spring Valley Bohemia, NY) 100 mg 1 capsule 3 times daily; L-Carnitine (Jarrow formulas, Los Angeles, CA) 250 mg 1 capsule 3 times a day; L-Carnitine (Now Bloomingdale IL) 500 mg, 1 capsule 3 times a day; Bovine Cartilage 750 mg Bovine tracheal cartilage, Chondroitin sulfate type II collagen, 750 mg per capsule, 4 capsules; 3 times daily. (It is believed the extracellular matrix Bovine cartilage provides extracellular matrix support functioning as an external stent in supporting the coronary arteries) Neocate infant formula (SHS International Liverpool England and Nutricia Gaithersburg, MD) 1 teaspoon approximately (15% amino acid content, antioxidant vitamins and minerals) 5 g emulsified by shaking vigorously with 3 ounces of spring water 1 to 3 times daily. Vita Carte, Phoenix, Biologies, Vista, CA, Bovine cartilage (1.2g per 3 capsules), chondroitin sulfate, glucosamine sulfate (1. Ig per 3 capsules), MSM (methyl sulphonyl methane, 300mg per 3 capsules) (NOW Foods, Bloomingdale, IL, 2 to 3 capsules, 2 to 3 times daily) Longevinex Antioxidant grape red wine molecule (French red wine extract and giant knotweed leaf extract providing lOOmg of trans resveratrol per capsule 215mg total) derivative in capsule form nitrogen environment production to avoid oxidation and spoilage and has 2J5mg resveratrol, quercelin dehydrate, 25 mg, rice bran extract (1P6), 75mg, rice bran oil (380mg), sunflower lecithin, (55mg), vitamin E mixed tocopherol, 5 mg, VSL (Gaithersburg, MD) lactic acid bacteria probiotic (a comparative product has also been used, Gr-dophilus, with 8 strains and 4 billion potency microorganisms, Lactobacillus acidophilus, Casei, L. Rhamnosus, Salivarius, streptococcus thermophilus, Bifidobacterium bifidum, longum and lactis) used nightly or a few times per week to avert constipation. Topical lotion (in accord with formulation first use in this series of inventions for torn rotator cuff, see example on page 94) pre-cordial sternal lotion application about ½ to 1 teaspoon dosage locally to include mammary artery resulted in complete relief of severe fatigue associated with an abnormal echo stress test. Similar relief of fatigue was noted immediately after coronary artery angioplasty and left anterior descending (LAD) coronary artery angioplasty and stent in treatment six years prior for a myocardial infarction.

In the treatment of recurrent gout with a uric acid level of 8 to 9mg %; and with classic findings of acute gouty severe inflammation associated with redness, swelling, pain and tenderness of metatarsophalengiel joint of the great toe, the present invention has also proved successful. This patient was usually responsive to Quercetin complex a xanthine oxidase enzyme inhibitor. This patient has a past history of multiple drug intolerances and allergies. They responded to indomethacine 50 mg. However, as with an}' aspirin like drug, NSAID severe flare up of ulcer like symptoms with pyrosis (heartburn) occurred several times, requiring weeks of antacid as Turns (calcium carbonate 750 mg GlaxoSmithKline Moon township, PA) or Rolaids (Calcium carbonate 675 mg, Magnesium hydroxide 135 mg: PFIZER, Morris Plains, NJ). This was relieved with bland food and/or milk for several weeks until finally relieved.

A hypertonic foot bath mixture was able to accomplish promptly without undesirable effect, after the use of the footbath, the reversal of the severe metatarsophalangeal joint arthritic pain characteristic of gout. Whereas indomethacine had accomplished, however it was contra indicated because of the side effect pyrosis (heartburn) that took several weeks to reverse. It prepared with about 2 gallons of luke warm water it is the only inflammation that does not tolerate hot compresses or baths) in fact, countermanded ½ to 1 cup Epsom salt for example generic, as Publix, 1/8 to 1/4 cup of the remaining ingredients including: Epsotherapy bath treatment (CVS Woonsocket, RI) or Dr. Teal's Epsom Salt (Dr. Teal's Dallas, TX); Extra Virgin Olive Oil (Vigo Tampa, FL); Shower Gel & foaming Bath ( Kiss my face Corp. Gardiner NY); Heal thyself Stress Relief Eucalyptus Basil shower gel (Noah's Naturals LCC Los Angeles, CA); Dead Sea Classics Bath Salts (Crystal Line New York, NY); Natural Mineral Bath, liquid Batherapy (Para Laboratories Homestead,NY): with the optional inclusion of phospholipid phosphatidyl choline 1.2 (Arlington Heights, IL) 3 to 6 capsules opened by cutting away the end of the capsule.

This was devised to mimic the therapeutic success of bathing in the hypertonic Dead Sea.

It is also pertinent that the molecular embryonic studies which are equivalent to the activation of the healing stem cells reveal that egg can be activated with hypertonic sea water which contains phospholipid, the bases of its ability to foam when stirred by the waves as well as its high concentration of salts such as calcium, magnesium and potassium. In production of the fertilization membrane even though the experimental sea animal egg has not been fertilized (referred to as parthenogenesis, stem cell like egg activity, without fertilization). It is believed from this subject composition of matter that phospholipid, as well as the osmotic hypertonicity of this bath are responsible for the successful therapeutic response of the gouty arthritic patient. This treatment was without side effects, but more importantly was effective in promptly and completely reversing the persistent gouty arthritis symptoms that might last associated and severe gout flare ups. It is believed the mechanism is based on the hypersensitive of these components and their osmotic pressure to draw the small uric acid crystal out of the circulation, its presence in the joint, as well as its soothing effects.

Case 25. Gout, treatment of acute gout arthritis in addition to coronary artery atherosclerotic heart disease

(Case 20 also suffered from gout)

The foregoing patient (Case 20) as cited, had required angioplasty and a stent for an acute myocardial infarction seven years prior and with reinstituting the subject composition therapeutics orally (Norwegian Salmon Oil, Carlson Laboratories Arlington Heights IL) 1000 mg 2 capsules 3 times daily; along with phosphatidyl choline 400 mg per 1200 mg capsule, 1 capsule 3 times daily; (C-GeI Carlson Laboratories Arlington Heights IL) Vitamin C 1000 mg 1 capsule 1 to 3 times daily; B vitamins particularly B6, folic acid B 12 have helped reduce the homocysteine* blood level from 15mg percent to lOmg or less percent (with each reduction in homocysteine of 4mg% there is a decrease by almost 20% in predisposition to coronary artery disease.) B50 Complex Caplets,l tablet twice daily; 50mg each of Thiamine Monohydrate Vitamin Bl; Riboflavin vitamin B2 (Twin Labs, America Park, UT); Niacin (Niacinamide); 50mg, Vitamin B-6 (Pyridoxine) 50mg, Folic acid 400mcg, B12 (Cyancobalamin) 50mcg, Biotin 50mcg, Pantothenic Acid 50mg (Sundown Inc.) Pantethine 450mg, 1 daily (Jarrow Formulas, Los Angeles, Ca); Folic Acid 800mcg (Natures Bounty, Bohemia NY); Vitamin B2 (Riboflavin) lOOmg 1 to 2 times daily (Twin Labs, America Park, UT); Selenium Methionine 200mcg (Douglas Laboratories, Pittsburg, PA); Beta Sitosterol 300mg, 163mg of Campesterol, 117mg of Stigmasterol plant sterols to biologically compete with the cholesterol animal sterols(Vitamin Shoppe, North Bergen. NJ); Branched Chain Amino Acid Complex, 300mg of L- Leucine, 150mg of IsoLeucine, 150mg L- Valine, 500mg L-Glutamine, taken as one capsule (Jarrow Formulas, Los Angeles, CA); Quercetin Complex, flavonoid antioxidant preventing flare ups of gout* along with preventing oxidation of low density lipids (LDL) 500mg, Bromelain 50mg, Citrus Bioflavonoids 50mg, Rose Hip 20mg, Acerola 20mg, Rutin l Omg, (Solgar, Leonia, NJ); (Coenzyme Q-10 (Co Q-IO) Spring Valley Bohemia, NY) 100 mg 1 capsule 3 times daily; L-Carnitine (Jarrow formulas, Los Angeles, CA) 250 mg 1 capsule 3 times a day; L-Carnitine (Now Bloomingdale IL) 500 mg, 1 capsule 3 times a day; Bovine Cartilage 750 mg Bovine tracheal cartilage, Chondroitin sulfate type II collagen 4 capsules 3 times daily. (It is believed the extracellular matrix Bovine cartilage provides extracellular matrix support functioning as an external stent in supporting the coronary arteries) Neocate infant formula (SHS International Liverpool England and Nutricia Gaithersburg, MD) 1 teaspoon approximately (15% amino acid content, antioxidant vitamins and minerals) 5 g emulsified by shaking vigorously with 3 ounces of spring water 1 to 3 times daily. Vita Carte, Phoenix, Biologies, Vista, CA, Bovine cartilage (1.2g per 3 capsules), chondroitin sulfate, glucosamine sulfate (LIg per 3 capsules), MSM (methal sulphonyl methane, 300mg per 3 capsules) (NOW Foods, Bloomingdale, IL, 2 to 3 capsules, 2 to 3 times daily) Longevinex Antioxidant grape red wine molecule (French red wine extract and giant knotweed leaf extract providing lOOmg of trans resveratrol per capsule 215mg total) derivative in capsule form nitrogen environment production to avoid oxidation and spoilage and has 215mg resveratrol, quercelin dehydrate, 25 mg, rice bran extract (IP6), 75mg, rice bran oil (380mg), sunflower lecithin, (55mg), vitamin E mixed tocopherol, 5 mg, VSL (Gaithersburg, MD) lactic acid bacteria probiotic used nightly or a few times per week to avert constipation. Topical lotion (in accord with formulation first use in this series of inventions for torn rotator cuff, see example on page 94) pre-cordial sternal lotion application about ½ to 1 teaspoon dosage locally to include mammary artery resulted in complete relief of severe fatigue associated with an abnormal echo stress test. Similar relief of fatigue was noted immediately after coronary artery angioplasty and left anterior descending (LAD) coronary artery angioplasty and stent in treatment five years prior of a myocardial infarction.

In the treatment of recurrent gout* with a uric acid level of 8 to 9mg %; with classic findings of acute gouty sever inflammation associated with redness, swelling, pain and tenderness of metatarsophalengiel joint of the great toe. This patient was usually responsive to Quercetin complex a xanthine oxidase enzyme inhibitor. This patient with multiple drug intolerance and allergy responded to indomethacine 50 mg, however as with any Aspirin like drug, NSAID severe flare up of ulcer like symptoms with pyrosis (heartburn) relieved with bland food or milk occurred a few days after resorting to this one drug for relief. A hypertonic foot bath mixture was prepared with about 2 gallons of hike warm water (is an unusual inflammation, in that the only inflammation that does not tolerate hot compresses or baths) in fact, countermanded ½ to 1 cup Epsom salt for example generic, as Puvlix, 1/8 to 1/4 cup of the remaining ingredients including: Epsotherapy bath treatment (CVS Woonsocket, RI) or Dr. Teal's Epsom Salt (Dr. Teal's Dallas, TX); Extra Virgin Olive Oil (Vigo Tampa, FL): Shower Gel & foaming Bath ( Kiss my face Corp. Gardiner NY); Heal thyself Stress Relief Eucalyptus Basil shower gel (Noah's Naturals LCC Los Angeles, CA); Dead Sea Classics Bath Salts (Crystal Line New York, NY); Natural Mineral Bath, liquid Batherapy (Para Laboratories Homestead.NY); with the optional inclusion of phospholipid phosphatidyl choline 1.2 (Arlington Heights, IL). This was devised to mimic the therapeutic success of bathing in the hypertonic Dead

Sea.

It is also pertinent that the molecular embryonic studies which are equivalent to the activation of the healing stem cells reveal that egg can be activated with hypertonic sea water which contains phospholipid, the bases of its ability to foam when stirred by the waves as well as its high concentration of salts such as calcium, magnesium and potassium. In production of the fertilization membrane even though the experimental sea animal egg has not been fertilized (referred to as parthenogenesis, stem cell like egg activity, without fertilization). It is believed from this subject composition of matter that phospholipid, as well as the osmotic hypertonicity of this bath are responsible for the successful therapeutic response of the gouty arthritic patient.

This treatment was without side effect but more importantly was effective in reversing the persistent gouty arthritis symptoms. It is believed the mechanism is based on the osmotic attraction of these components and their osmotic pressure to draw the small uric acid crystal out of the circulation and its presence in the joint as well as its soothing effects. It is believed this affect could be used for possibly saving a patient one dialysis treatment a week with chronic kidney disease and renal failure, and its serious complication of uremia, the buildup of the urea waste product of protein metabolism. This dramatic success using such safe innocuous products for complications of catabolic products of protein metabolism, uric acid in the case of gout, and urea in the case of kidney failure provides a simplistic therapy for two conditions that have serious disease consequences.

Case Group 26. Anti-Cancer Therapeutics 70 In- Vitro studies and end stage cancer patients In -Vivo studies

Of 70 studies of the foregoing 247 clinical and preclinical studies, representing 44 bio-chemicals, 27& (12 of 44) dramatized a 3-D bio-chemical trend. This trend is also computerizable and provides positive therapeutic results, killing in excess of 88% of cancer tissue within 24 to 48 hours. Five (5) of these studies demonstrated a cancer cell kill rate of 99% to 100% in the same time frame. This is particularly noteworthy since these results were achieved using FDA pre-approved-as-safe components comprising subject composition therapeutics synthetic cell-like micro-environment therapeutics.

Each step represents a cell biology model of the normal process that has the capacity to reverse the diseased cell biology model: Pre-clinical Anti-cancer Hydrophilic Surfactant Therapeutic Examples:

The degree of anticancer hydrophilic surfactant therapeutic effect is proportionate to the hydrophilicity whether hydrophilic phospholipids, hydrophilic surfactant activity of free amino acids, or whether this effect is seen through the extracellular matrix glycoprotein protein that has more hydrophilicity (post-translational) and directional effects of the carbohydrate moiety (like the analog directional model of glycosylated extracellular matrix (ECM) protein, functioning directionally as a 'railway tag').

Cancer Cell In- Vitro Therapeutic Trial of Efficacy Study and Results Cell line and cell culture conditions and preparation of the Helen Lane derived cancer cells (American Type Culture Collection (Bethesda, Maryland), HeLa Cells cancer cell line.

Originally donated by Helen Lane and her family to advance the study of cancer and known as the HeLa Cells.

Cell line and Culture Conditions:

The cell line MCF-7 was maintained in RMPI-1640, supplemented with 10% fetal calf serum (FCS), Penicillin/Strep (1.1%), and Sodium bicarbonate (7.5%). This was incubated at 37°C with 5% C atmosphere. The adherent cells were harvested upon 90-95% confluence or monolayer coverage.

Preparation of Cells:

The initial cell counts were conducted by detaching the MCF-7 cells with trypsine EDTA. This cell solution was incubated for five minutes and spun in the centrifuge at 1200 rpm. The pellet was re-suspended with RMPI-1640. A 1 :10 dilution of cells to trypan blue was used for determining cell counts using a Petroff Hauser Hemocytometer chamber.

At the end of the 24 to 48 hour observation of in-vitro, therapeutic efficacy in cancer cell kill (apoptosis), the resultant spectrophotometrically studies were further examined microscopically for the presence or absence of cancer cells in verifying the cancer cell kill (apoptosis). Tables 3 A, 3B, 3C, and 3D show the results of those treatments.

Clinical Anti-cancer Case Reports (clinical examples):

Treatment of Tonsillar Cancer, Anal Cancer, and Small Cell Lung Cancer At the time of treatment, Patient 1 was a 35 year old male diagnosed with tonsillar cancer. His prognosis was determined to be poor. At the time of treatment, Patient 2 was an 81 year old male diagnosed with anal cancer having local dissemination. At the time of treatment, Patient 3 was 70 a year old female diagnosed with intractable small cell lung cancer, with metastasis and cachexia. Patient 3 weighed approximately 90 lbs and compl ained of fatigue.

Example 1 : Patient 2 received a sterile non-pyrogenic composition of about 20% essential fatty acids (a mixture of linoleic and linolenic acid), 1.2% egg yolk phospholipid, and about 2% glycerin in water for injection. This composition is sold commercially as "Intralipid," and was obtained from Baxter Healthcare Corp. (Deerfield, 111.); see attached photocopy of Intralipid IV package. Intralipid is manufactured for Baxter Healthcare by Fresenius Kabi AB (Uppsala, Sweden). 500 milliliters of Intralipid was given intravenously three times a week for one week. Patients 1 and 3 received a similar composition called Liposyn (Abbot Laboratories) intravenously three times a week for one week. Patient 2 received 500 ml per dose and Patient 3 was administered only 250 ml per dose. Liposyn is a sterile, nonpyrogenic fat emulsion for intravenous administration, which contains about 10% safflower oil, 1.2% egg phosphatides and about 2.5% glycerin in water for injection.

Patients 1 , 2, and 3 showed an improvement in overall heath, including an increase in energy and relief of the fatigue and listlessness characteristic of cancer and disseminated cancer. Clinical signs of disease were visibly lessened. Regarding Patient 1, the prognosis was so grave that any signs of recovery were unexpected. However, after one week of treatment, it was reported that the improvement in Patient 1 was so dramatic that heath-care personnel had to verify the patient's name to be sure he was the same patient that had been admitted. Patient's 1 improvement continued throughout the entire course of treatment. Patient 2 was observed walking down the hall one month after treatment, and his gait was remarkably brisk in view of his age, and the extent and location of his anal cancer. Patient 3 suffered from the fatigue characteristic of cancer, particularly when complicated by metastasis and cachexia. However, 24 hours after administering the composition to Patient 3, her fatigue completely resolved, an unexpected result in a patient with such poor prognosis. This complete clearance of fatigue was noted again, lasting for 24 hours, after administration of the next two doses.

Example 2: Treatment of Squamous Cell Cancer, Lung Adenocarcinoma, Metastatic Lung Cancer and Anal Cancer

Patient 4 is a 57-year old male with squamous cell cancer of the hypopharynx. Within one week, this patient was given a single dose of 500 ml Intralipid (20%) and a single dose of 500 ml Intralipid (10%). After this treatment, the patient showed some clinical improvement in energy levels and a decrease in lassitude. Patient 5 is a 74-year old female with adenocarcinoma of the lung. This patient received three 500 ml doses of Intralipid (20%) in one week, and showed moderately increased energy levels and a reduction in lassitude.

Patient 6 is an 81 -year old male suffering from right upper lobe lung cancer with metastatic spread in cervical lymph nodes right to left. This patient received one-daily doses of 250 ml Intralipid (10%) for 3 consecutive days. Patient 6 showed marked improvement in energy levels and a more than 60% lessening of radiation treatment side effects.

Patient 7 is an adult male, 82-years old, suffering from anal cancer complicated by severe cachexia. At the time of treatment, this patient weighed approximately 144 lbs. Upon 3 times weekly dosing with 500 ml Intralipid (20%), the size of a superficial tumor in the anal and perianal area (initially 5 cm) was reduced 40% in size after three days of treatment. After five treatments, the enlarged inguinal lymph nodes returned normal. One indication was that local dissemination of the cancer had improved.

From clinical observations of these patients before, during and after treatment with the Intralipid and Liposyn compositions, it is believed that the improvement in their clinical condition was the direct result of administering the composition.

Subject Composition Anti-Cancer Therapeutics In- Vivo Pilot Study:

By providing more hydrophilic surfactants with biochemical and biophysical parameters obverse to cancer offers an effective, safe, opportunity for in-vitro, and in-vivo therapeutics with comparative anticancer mathematical ratios and formulations for further providing maximum anticancer efficacy selectivity.

Not only is this applicable for subject composition anticancer therapeutics in adults, but also for children with cancer, where self image and innate immunity are so important. For all ages, subject composition therapeutics provides an unparalleled safety that does not interfere with growth and development.

The biochemical basis for subject composition therapeutics synthetic stem cell biochemical microenvironment therapeutic composition of matter anabolically reverses damaged and diseased tissue. Pilot study: 8 end-stage cancer patients, seven of which were acute, received 7 to 10 day intravenous egg yolk phospholipid therapeutics. Similar synergy and enhancement of therapeutic response and improvement of quality of life in end-stage cancer has been noted.

One patient with colon cancer that metastasized to the lung, despite complete removal of the colon, showed therapeutic response over a one year observation. His bowel cancer that metastasized to the lung was documented as normalized by a PET scan. Therapy has continued.

Case 27. Metastatic Cancer

A 50 year old male: Metastatic bowel cancer that metastasized to the lung was normalized, using the foregoing stem cell microenvironment anti-cancer subject composition therapeutics outlined herein. Extensive follow-up and treatment has continued because of the guarded prognosis of this disease. This treatment has consisted of a hydrophilic amino acid L lysine, hydrophilic phosphatidyl choline, 500 mg two times daily Carlson laboratories, Arlington Heights Illinois, extracellular matrix shark cartilage 2 capsules three times a day. Cartilade, (Ontario, Canada, formerly Biotherapies, Inc., Fairfϊeld NJ.) ; vitamin C (ascorbic acid) (Carlson laboratories) 500 mg 2 capsules 3times daily. His pre-treatment therapeutic composition anticancer prognosis was poor and the patient was given only "one month to live" and advised to get his affairs in order. The first sign of improvement was a return of his energy where he was able to keep up, for the first time, with his friend's pace walking in the mall. This was followed by being x-rayed again ordered by his oncologist. The x-ray showed a normalcy of his previously highly abnormal metastatic cancer found in the lung. The present invention thereby achieved a non-invasive, risk free medical lumpectomy for metastatic bowel cancer which spread to the lung. (Not known to the prior art). In the past few months the oncologists also provided 5 FU 1.5 mg intravenously every few weeks.

Treatment that was initiated about 1 year ago also comprised of Tagamet (Cimetadine OTC (over the counter) Glaxosmithkline Research triangle Park, NC) 800 mg. daily of about 4 month duration because of the increased bowel cancer longevity to 85% survival in 5 years versus 45% with 5 FU alone as reported with Tagamet an H2 (histamine 2 blocker). This observation was further confirmed by finding an increase in histidine decarboxylase enzyme accounting for the increase in histamine derived from decarboxylated histidine.

The advantageous use of the PET scan as a metabolic anabolic test of subject composition therapeutic efficacy, can be best illustrated by the before mentioned diagnosis male patient with stage IV metastatic bowel cancer to pulmonary tissue with PET scan resolution with subject composition therapeutics. A consultant oncologist stated he has never seen a resolution in stage IV metastatic cancer (the response associated with the subject composition therapeutic anticancer use of synthetic stem cell-like microenvironment therapeutics). This can be illustrated by the enclosed PET scan which metabolically tracks reported subject composition anticancer therapeutic response.

Three other end stage cancer patients were treated with phospholipid derived from egg yolk provided by Baxter and Abbott Laboratories (directed to cachexia) and used in radiation oncology the prevention of radiation burns in a (case 1) male patient age 72 with maxillary sinus cancer, (case 2) in esophageal cancer in a patient age 60, and (case 3) recurrent bladder cancer in a patient in her late 60s. This is similar to the therapeutics cited here that normalize the energy production in treating end stage cancer patients. A whole-body PET scan provided the following information:

History: Colon Cancer

Attenuation corrected imaging of the neck, chest, abdomen and pelvis was performed on a dedicated PET scanner following intravenous injection of 11.23 mCl of FDG. Blood glucose was 168 at the time of injection. Comparison is made to previous study of September 12. 2007.

Neck: Negative

Chest: There has been complete interval resolution of abnormal FDG activity associated with multiple pulmonary nodules as demonstrated on previous study. Although CT scan confirms the presence of small residual nodular densities, these have decreased significantly in size. For example, the dominant left infrahiler nodule on the current study now measures 17mm, as compared with 29 mm on the previous examination. Several additional bilateral nodules have also decreased in size. There are several peripheral benign appearing 3 to 4 mm nodules which are stable in size, but not associated with abnormal FDG activity. There is no evidence for residual abnormal activity within the lungs or mediastinum. Abdomen: normal

Pelvis: Again noted is mildly increased FDG activity at the level of rectal resection, with a maximum SUV of 8.1. This compares with an SUV of 5.3 on the previous examination. There is no associated mass or pelvic adenopathy. Bone marrow: There is a mild degree of diffuse marrow activity, midly increased from prior study, with SUV's in the range of 3.1 to 5.5. There is no focal area of increased metabolic activity. This is nonspecific in appearance and may represent physiologic marrow activity. Impression: 1. Complete interval resolution of abnormal FDG activity associated with decreasing size of multiple pulmonary nodules as demonstrated on prior study of September 12, 2007. This would be most consistent with resolving pulmonary metastatic disease.

2. Small focus of mildly increase FDG activity at the level of rectal resection maybe slightly increased when compared to prior study. This is of uncertain clinical significance and will require continued follow-up.

Case 28. Metastatic Cancer in Equine Veterinary Care of Metastatic Melanoma

In addition to the foregoing therapy of case 27, the following components of subject composition are given: (administered by stomach tube) coenzyme Q-IO, an anti-metastatic factor, (spring valley, Nature's Valley, Bohemia, NY) 300 mg, 2 capsules 3 times daily; folic acid, (countering potential deficiency that functions as a co-carcinogen) 800 micrograms, 6 tablets, 3 times daily (Life Extension Boca Raton, FL); and phosphatidyl choline (a hydrophilic surfactant), 1.2 grams, 6 capsules, 3 times daily (Carlson Laboratories, Arlington Heights, IL), with its in-vitro anticancer effect of 88%.

If anticancer response is not adequate with above components, the following will be added:

Neocate Infant Formula (with an anticancer in-vitro efficacy of 83% cancer cell kill rate in 24 to 48 hours) with the amino acids specified by the genetic code of targeted developmental protein, such as human breast milk; 6 teaspoons, 3 times daily (SHS

International, Liverpool, UK and Nutricia Gaithersburg, MD); Bovine Cartilage, 750 mg capsules, 24 capsules, 3 times daily (Phoenix Biologies Vista, CA).

Plant derived Cytoplasmic Factor that has a nuclear inhibitory effect, suppresses mitosis in cancer, is ½ fresh carrots and ½ celery prepared in a juicer as a beverage to be given as 32 ounce glasses, 3 times daily.

Case 29. Baseline Management of Crohn's Disease

Patient was a 76 year old female who had suffered from Crohn's disease for more than three decades. This patient's symptoms included diarrhea, constipation, severe bouts of abdominal pain and fever, G.I. bleeding, generalized aching, extreme fatigue, nausea, and food and dairy intolerance. She was being treated with 4 mg of corticosteroid, once daily, with no response. At the time, patient had been corticosteroids for approximately 30 years. Corticosteroid dosing was then increased to 4 times daily for acute flare ups.

During the first decade of management, she was taking Azulfidine, 500mg, one to three times daily with good control. This had to be discontinued due to complication of severe headaches. Two decades ago, flare up was so intense that major abdominal surgery was required, and ten inches of bowel was resected. It is well known that this surgical care, even though extensive, is only symptomatic and does not eradicate the significant predisposition for Crohn's disease with its guarded prognosis. This dilemma was addressed through the following advances in management with progressive improvement, and significant reduction in dosage of corticosteroids. However corticosteroids (particularly long term use as required in this patient's treatment) until the forgoing treatment was developed, have a multiplicity of major side effects. These multiplicities of side effects seen in this patient include extensive bruising, and interference with healing.

These major side effects were addressed by the foregoing treatment which made possible a major reduction of corticosteroid requirements, with control of flare ups and maintenance and prolonged remission.

A medicament according to the present invention, was administered to this Crohn's disease patient, comprising about 10.6 g Neocate infant formula SHS Liverpool, UK containing L-amino acids and glycine, in the genetic code and molar ratio of human tissue (breast milk and stem cell human tissue (See Table 4); about 50-100 mg lecithin as de-oiled soy lecithin 40 % phosphatidyl choline (Central Soya. Decatur, 11 now Solae, St. Louis Mo. I; about 12.5-40 mg phosphatidyl choline; Advanced vision research, Woburn, MA Theratears Nutrition, about 225 mg EPA from fish oil; 500 mg flaxseed oil (equivalent to about 275-325 mg linolenic acid); and extracellular matrix components comprising collagen, proteoglycans aggregate complex of cartilage and chondroitin sulfate Cartilage, Quebec, Canada, Atrium Biotechnologies, (shark cartilage 740 mg per capsule, twice daily).

Progressive improvement was noted with this formulation, and the patient was able to reduce the corticosteroids by 25% (going from 1 tablet daily to 1 tablet alternating with ½ tablet daily (the major flare-up of Crohn's Disease associated with severe diarrhea and abdominal pain were no longer evident, therefore, the steroids no longer required the count down method of 4 tablets for 1-2/days. 3 tablets for 1-2/days. 2 tablets for 1-2/days). Since achieving this baseline of 25% reduction of steroids; 1 tablet alternating with ½ tablet was administered daily. The formula includes the following:

-1-2 teaspoons Neocate (SHS International, Liverpool, UK)

-!4 teaspoon of soy phospholipid as de-oiled Soy Lecithin Powder (Solec, St. Louis, MO) -Four 740 mg 2-3 times daily shark cartilage (Atrium Biologies, Quebec, CA) or a similar dose of bovine cartilage (Phoenix Biologies, Vista, CA)

-One Multi -vitamin daily, (Centrum, Madison. NJ or Central- Vite, Eckerd Corporation, Warwick, RI).

Patient continued to improve in several weeks to one month. During this time we reduced the steroid dose from alternating 1 tablet and ½ tablet daily. This alternating of 4 mg tablets of corticosteroid medication (Aristocort, Lederle American Cyanamide, NJ, currently marketed by Fujisawa, Deerfield, IL) continued. This was approximately a 25% decrease in steroid usage with good control of Crohn's disease.

Subject composition therapeutics was used as a technique and synergistic composition of 1 to 2 teaspoons EO28 2 to 3 times daily as a substitute for Neocate in foregoing synergistic composition for three to four weeks. EO28 palatability was greatly enhanced by emulsifying the product in 3 oz of spring water (Crystal Springs, Paso County, FL., thereby, avoiding 30% noncompliance of distasteful presentation in contrast to the small quantity utilized in patient care presented here by a multiplication of one teeth one to 2 teaspoons of EO28, and 20% were unresponsive probably of this amount of free L-amino acids and glycine (poorly tolerated with the dosage magnitude associated with such increase in absorbable micronutrient particles and associated hyper-osmolar intolerance by the chronically inflamed bowel wall including ileitis). Corticosteroids were reduced by 50 to 75% at this time. Greatest compliance was 1 to 2 teaspoons, 3 times daily. EO28 Extra was compared alone without the Neocate and the findings were better in that approximately 50-75% less steroids were required. With repeated withdrawal and re- addition of Neocate, it was ultimately concluded that the patient was slightly better (about 25%) with the Neocate re-addition. This totaled to a 90% reduction in steroid usage of ½ tablet, 3 times per week. (See Table 4)

Also, 15 grams of free amino acid in the molar ratio as specified by the genetic code per 100 grams of Elemental 028 Extra, unfiavored. Protein equivalent 12.5 grams per 100 grams, Energy kJ (Kcal) 1871 (443). Vitamins, Minerals and Trace Elements per 100 grams. Vitamin A 330 micro grams, Vitamin D₃ 2.5 micro grams, Vitamin E 6.1mg, Vitamin C 28.3mg, Vitamin K 25 micro grams, Thiamin O.όmg, Riboflavin O.όmg, Niacin 4.2mg (mg. NE 9.0) , Vitamin B₆0.8mg, Folicine 83.3 micro grams, Vitamin Bi₂ 1.7 micro grams, Biotin 18 micro grams, Pantothenic acid 2 mg, Choline 91.6mg, Inositol 9.2mg, Sodium 305 (13.3mmol), Potassium 4.66mg (11.9mmol), Chloride 3.33mg (9.4mmol), Calcium 246mg, Phosphorus 200mg, Magnesia 81.6mg, Iron 4.2m g, Copper 0.4mg, Zinc 4.2mg, Manganese 0.6mg, Iodine 33.3 micro grams, Selenium 15micro grams, Chromium 15 micro grams, Molybdenum 33.3 micro grams.

Carbohydrate 59g (5.31 sugars), Saturated fat 6.7g, Monounsaturated fat 7.4g, Polyunsaturated fat 2.4g, E028 Extra, Liverpool UK

1 packet VSL Probiotic Lactic Acid Bacilli also helped in further synergistically optimizing the EO28 effect. With this addition, the synergism of maintaining Crohn's disease ileitis remission was achieved and maintained. This probiotic appears to displace the more pathogenic saprophytic microorganisms' bowel flora present on the inflamed ileum of the Crohn's ileitis. This provided a more complete synergism in mimicking human tissue, without resorting to the usual dose required (20 to 40 times greater as 20Og, 1 to 2 times daily than the amount used here in this therapeutic synergistic mixture presentation).

However, there was one side effect of steroid withdrawal: progressively severe arthralgia. This is a common side-effect of steroids reduction after 30 years usage. Arthralgia was almost gone entirely after use of the following:

-Four 740 mg shark cartilage (2 to 3 times daily)

-Four 740 mg bovine cartilage (2 to 3 times daily)

-500 mg Curcurmin (turmeric derived Indian herb) 1 capsule, 2 to 3 times daily (Jarrow Formulas, Los Angeles, CA). This form of tuπneric does not create any burning sensations like the spice does. The patient claimed to feel stronger and more alert as the curcurmin supports the adrenal cortex.

The polymeric proteoglycans were discontinued due to question of sensitization as part of the autoimmune mechanism of arthritis flare-ups. Instead the following were used:

-1 ,000 mg MSM (methylsulfonylmethane) 1 capsule, 2 to 3 times daily (Nature's Bounty, Bohemia, NY)

-1,000 mg Glucosamine/Chondroitin sulfate 2 capsules 2 to 3 times daily (Life Extension, Ft. Lauderdale, FL)

The following were later added: -1,000 mg Omega 3 Fish Oil 2 capsules, 2 to 3 times daily (Leiner Health Products, LLC, Carlson, CA)

-500 mg Bromelain 1 capsule, 2 to 3 times daily (Natural Factors, Everett, WA)

-1,000 mg Garlic 1 capsule, 2 to 3 times daily (Nature's Bounty, Bohemia, NY) -520 mg Panax Ginseng 1 capsule, 2 to 3 times daily (Now Foods, Bloomingdale, IL)

-1,000 mg Methyl B 12 1 Lozenge 2 to 3 times daily (J arrow Formulas, Los Angeles, CA)

- 400 IU Vitamin D3 1 capsule daily (Jarrow Formulas, Los Angeles, CA)

Without steroids, profuse bleeding with the mildest injury, as well as, constant and severe bruising (ecchymoses) of the forearms was no longer evident. It is believed with this foregoing therapeutic synergism is an effect that approaches 100% remission without the requirement every few months of countdown dosages of corticosteroids starting with 4 tablets 1 to 2 days, and in 3 tablets a day, for 1 to 2 days followed by 2 tablets a day for 2 days and then 1 tablet daily. Inadvertently, the patient received EO28 Extra (SHS International, Liverpool, UK) with a difference in composition of primarily long chain fatty acid fats. The ingestion of one teaspoon of this product was associated with an acute flare up (within a period of five to ten minutes), of severe diarrhea, this was noted several times. In showing the contents to her physician the composition difference was noted and the patient was instructed to re order the EO28 Extra which minimized the fatty acid fats, (correlating with similar clinical gastrointestinal intolerance to the ingestion of fatty foods and improvement with avoidance). By correcting this inadvertent mistake, subsequent use of the EO28 Extra was well tolerated and the experience was looked at as a double blind test, in that neither the patient nor the physician knew about this inadvertent change in composition of EO28 Extra, which was corrected without further side effects.

A side effect of withdrawal of prolonged steroids usage over several decades as the occurrence of symptoms of arthralgia without gastrointestinal symptoms flare up which were significantly helped by glucosamine sulfate 500 mg, MSM (methyl sulfonyl methane) 400 mg; chondroitin sulfate 500 mg, (Vitamin Shoppc, North Bergen, NJ) 2 capsules, 2 to 3 times daily; and bovine cartilage 750 mg per capsule four capsules dosage containing bovine tracheal cartilage proteoglycans with chondroitin sulfate 750 mg, type II collagen 720 mg, 2 to 3 times daily Vita Carte, Phoenix Biologies, Vista, California, along with Aristocort 2 milligrams (1/2 of 4 milligram) tablet daily, initially one half a tablet daily, alternating with 1 tablet daily until arthralgia subsided.

It is believed that the arthritic flare up may be representative of hypersensitivity reaction predisposition. Pertinent childhood history of moderate recurrent arthritis was relieved via elastic bandage wrapping. The predisposition in this patient was apparently masked by the long-term corticosteroid requirements till the development of this subject therapeutic composition. Based on our progressive success with the organizational matrices of therapeutic subject composition, a free amino acid derived from bovine cartilage and its collagen in the hydrolyzed form represents pre-protein precursor targeted extracellular organizational matrix. It is, in a sense biochemically 'invisible', immunologic 'self) derived from bovine cartilage hydrolysate, and would be a significant benefit as 1200 rag collagen hydrolysate dosage per three capsules, Genacol, Blainville, Quebec, Canada three capsules two to three times daily hypoallergenic substitute is used to avert flare up of arthritis manifested by ankle, feet, and hands, with stiffness, and difficulty walking upon awakening in the morning. She continues steroid reductions to approach discontinuance with greatly diminished bruising and occasional injuries are associated with minimal healing disability (currently ½ a tablet daily of Aristocort, Fujisawa).

Case 30. Crohn's plus the complication of a wound that failed to heal secondary to leg trauma This intractable wound, wound healing impaired by long term corticosteroids. The therapeutics response that was helpful to both the Crohn's patient and her complication by using this steroid sparing therapeutic subject composition. (See Figure 1OA and 10B)

Steroids interfere with healing, an interference that hampers recovery in both the

Crohn's Ileitis and wound healing. In 4 weeks of this therapeutic subject application, the wound completely healed, and did not require the full thickness skin graft (with the use of steroids, the patient would have had 2 wounds that would not have healed.) Her Crohn's

Ileitis continued to improve even with lessened medication.

Failure to heal: A component of cell/tissue immune functionality - Similar therapeutic response has been noted in reversing failure to heal the wound accidentally inflicted upon the medial aspect of the lower leg, exemplified by a patient who was being scheduled for a full thickness skin graft.

Case example continued with therapeutic subject composition and now including wound healing with therapeutic subject composition. Patient was scheduled for immediate skin grafting which was averted with the following subject composition therapeutics:

Formulation was both ingested orally and applied topically surrounding the wound, in a sterile environment. Results were accomplished after less than a month of application without grafting.

Non-surgical Non-steroidal Reversal of Severe Chronic Ileitis (Crohn's Inflammatory Bowel

Disease)

Similar responses to subject composition therapeutics have been noticed with Crohn's disease since the foregoing patient was able to lessen the need for corticosteroids by at least

50%.

These clinical effects were observed in 4 to 6 weeks with the use of therapeutic components of subject composition therapeutics that have been incorporated in specified formulae and ratios. The formula includes the following given orally, and about ¼ to ½ (half) a teaspoon of each of the foregoing items was applied locally around the wound:

Neocate infant formula (SHS International Liverpool UK and currently Nutricia

Gaithersburg, MD) one to 2 teaspoons emulsified in Zephyrhills Spring water, Paso County

Florida -Four 740 mg 2 to 3 times daily shark cartilage (Atrium Biologies, Quebec, CA) or a similar dose of bovine cartilage. Clinically concluding the bovine cartilage (Phoenix

Biologies, Vista, CA) may have been somewhat more effective in the synergism.

- !4 teaspoon Soy Lecithin as phospholipid powder (Solec, St. Louis, MO/when first used was (manufactured by Central Soya, Decatur, IL); or most recently: One 1,000 mg phospholipid daily in the form of phosphatidyl choline (Carlson Laboratories, Arlington

Heights, IL). One capsule, 2 to 3 times daily.

-In the case of trauma, as shown in the progressive major injury of the leg of this patient, this formulation was also used locally in addition to Zinc Oxide Vitamin A&D cream

(Schering-Plough Health Care Products, Memphis, TN). -8,000 IU Vitamin A (Pharmavite, LLC, Mission Hills, CA), which was expressed from an open capsule applied around the wound. This was in addition to local care with hydrogen peroxide, compresses, with sterile gauze followed by Bacitracin. This example describes the foregoing patient case and the onset of her treatment. Her prior treatment of corticosteroids interfered with healing. The systemic and local treatment significantly contributed to the reversal of both wound care and Crohn's disease ileitis. The large dosages of steroids significantly interfered with healing and with wound contraction that we reduced with subject therapeutic composition orally and placed locally around the wound to diffuse into the surrounding tissue to synergize healing and recovery. The present invention therefore, aveited the need for a full thickness skin graft that was prescribed, but not scheduled.

This patient's leg trauma had a major complication due to the management of Crohn's Disease with steroids, as steroids interfere with healing. The patient had spiked her leg with her high heel shoe during a fall, resulting in a deep laceration requiring 23 sutures. Half the sutures sloughed out. The attending plastic surgeon planned a full thickness graft, which the following treatment was able to avert. We developed a cream that was similar to the oral medication. This cream was used locally around the wound (vitamin A was applied directly to the wound). These synergistic components therapeutically mimicked human tissue.

Similar responses to subject composition therapeutics have been noticed with Crohn's disease since the foregoing patient was able to lessen the need for corticosteroids by at least 50%.

Prolonged use of steroids resulted in a major healing disability in the foregoing case. Thus, subject composition therapeutic steroid sparing had two significant therapeutic benefits, emphasizing its drug safety. In fact, this may be another factor in limiting the healing of Crohn's disease and its chronicity.

The radioactively tagged leukocytes seen radiographically take part in the severe inflammatory changes, which are reversed in 4 weeks and included in subject composition therapeutics. This includes clearance of chemo-attractive inflammatory activity and associated cytotoxic T-lymphocytes (CTL). This is also the response that the organ transplant surgeon is seeking. Radiograph tracking of therapeutic response of patients with radioactively tagged leukocytes.

Similar biochemical anti-inflammatory tracking has been performed with incubation of this subject composition component therapeutic ratio and formula with Crohn^'s diseased, biopsied tissue in 24 hours resulting in reduction of inflammatory cytokine IL-Ib concentration by over 80%. This reduction is significantly greater compared to that seen in normal colonic tissue control. This therapeutic component composition also leads to an associated relative increase in inflammatory antagonist (inflammatory receptor antagonist, IL-IRA).

Failure to heal was associated with prolonged use of corticosteroids for long term management of Crohn's disease when the patient sustained severe trauma to her leg. If a full thickness graft were performed, as suggested by the plastic surgeon, wound healing would now be inflicted upon two areas. Half of the 23 sutures dehisced. The patient responded progressively within 1 month of topical application of subject composition therapeutics which was placed around the wound with the in addition of oral subject composition therapeutics. In view of complete wound healing, without complication of scar, the planned graft was cancelled. Optimizing the treatment of the wound with subject composition therapeutics we found we were at the same time normalizing the Crohn's disease, thereby lessening the need for steroids.

Even though the acute use of corticosteroids arrest emergency flair ups of such diseases as inflammatory bowel disease, illustrated by Crohn's ileitis, one wonders that even though this arrested a severe acute flair up did its failure to heal imposition on all the tissues of the body play a role on perpetuating the disease. In fact, this may be another factor in limiting the healing of Crohn's disease and its chromcity. With the foregoing management directed to maximize and optimize her therapeutics in a steroid sparing fashion, she is able to take ½ a of a 4 mg tablet of Aristocort, (2 mg). The least steroids she has required in more than three decades and her steroid complication of bruising is greatly diminished, and injuries that do occur are minimal and easier to manage routinely. Where as, with the past severe trauma that resulted in a wound that wouldn't heal, her tissues seem to have fallen apart more profoundly than one would have expected with the foregoing injury.

Case 31 A. Management of Sterility

One patient of child bearing age was treated for management of sterility. (Her husband had a vasectomy repair). She was treated with folic acid, 400 mg daily, and in several months she conceived, at this time she is about 6 months pregnant with uneventful pregnancy. It is important to note, as a continuum of molecular embryogenesis, that this treatment has also been used during pregnancy, to prevent neural tube defect.

Case 3 IB. A mare is being treated with folic acid dosage adjusted since the horse (mare) weighs approximately 6-7 times more than the women seven times the 800 micrograms of folic acid is used per dose and was shipped in plastic packets to be added to Karo syrup to be administered by the equine veterinarian to the horse (mare) for reversal of sterility.

Case 31C.

Since activation of the ovum response to fertilization is shown to be activated by case 31 it was felt that this activation of the therapeutic stem cell could be accomplished in the same fashion and folic acid powder from the 800 micrograms capsule (Solgar, Leonia, NJ) was included in the transdermal cream. This is to be used in equine veterinarian care to enhance therapeutic response such as but not limited to musculoskeletal diseases. This was shipped for human pilot study trial in one patient that has a neural malfunction secondary to a herniated collapsed lumbar disk impending on the lumbar nerves exiting the spine and going to the leg associated with a foot drop. It is suggested this be used over the malfunctioning nerve in the leg as well as over the spinal area of neural impingement. Note: It is anticipated that this effect might be the same as crushing the vagus nerve with the sheath having within it nutrients that provided reversal of vaguely neuronal activity. This was successful and averted the dumping syndrome when the vagus nerve is transected for complications for a peptic ulcer, (ref. Journal of Physiology, Vol.167 #3 Dec. 1951, L.S. Girsh & M.H.F. Freedman)

Case 3 ID.

Hyaluronic acid Serum (Now, Bloomingdale, IL. spray bottle) added 1-2 sprays per four once bottle of transdermal cream. Prepared for equine veterinarian care and human care for tendonitis and synovitis both are effective and tolerated which we anticipate as a FDA approved component. We will incorporate both for neuromuscular disease, arthritis, tendonitis and synovitis for human use including trauma and ports medicine and equine use for the same indications. Case 32. Chronic Renal Failure Requiring Dialysis

It is believed this effect could be used for possibly saving a patient with chronic kidney disease and renal failure on dialysis treatment weekly as determined by monitoring the blood urea and nitrogen. This increase in blood urea and nitrogen is known as the serious complication of chronic renal disease, uremia. Urea represents the buildup of the urea waste product of protein metabolism commonly seen in Chronic Renal disease (it is also referred to as pre-renal if the cause is other than renal disease). This dramatic success, using such safe innocuous products for complications of catabolic products of protein metabolism, uric acid in the case of gout, and urea in the case of kidney failure, provides a simplistic therapy for two conditions that have serious disease consequences.

A hypertonic foot bath mixture was prepared with about 2 gallons of lukewarm water (is an unusual inflammation, in that it is the only inflammation that does not tolerate hot compresses or baths) in fact, countermanded ½ to 1 cup Epsom salt for example generic, as Publix, 1/8 to 1/4 cup of the remaining ingredients including: Epsotherapy bath treatment (CVS Woonsocket, RI) or Dr. Teal's Epsom Salt (Dr. Teal's Dallas, TX); Extra Virgin Olive Oil (Vigo Tampa, FL); Shower Gel & foaming Bath ( Kiss my face Corp. Gardiner NY): Heal thyself Stress Relief Eucalyptus Basil shower gel (Noah's Naturals LCC Los Angeles, CA); Dead Sea Classics Bath Salts (Crystal Line New York, NY); Natural Mineral Bath, liquid Bath Therapy (Para Laboratories, Homestead, NY); with the optional inclusion of phospholipid phosphatidyl choline 1.2 (Arlington Heights, IL) 3 to 6 capsules opened by cutting away the end of the capsule.

Case 33. Atherosclerotic disease of the aorta and its tributaries such as aortic aneurysm, coronary artery disease, and/or glomerulonephritic renal damage to avert invasive surgical care

In reconstituting the aorta and its tributaries the extracellular matrix aortic extract is used as the highly purified bovine derived glycosaminoglycans normally present in the order including heparin sulfate, hyaluronic acid, chondroitin sulfate, sulfate, dermatan sulfate, and associated hexosaminoglycans. Dosage 100 mg daily to three times a day to reverse atherosclerotic damage and prevent its recurrence along with the prevention of lipid cholesterol plaque deposits and associated lowering of low-density lipoprotein and elevating high density lipoprotein.

Case 34. Metastatic Cancer in Equine Veterinary Care of Metastatic Melanoma; also applicable in human melanoma using l/6ⁿ (one sixth) the dosage based on comparative weight ratio of a human to a 1,200 pound horse. In addition to the foregoing therapy of case 27, the following components of subject composition are given: (administered by stomach tube) (1.) coenzyme Q-IO, an anti- metastatic factor, (spring valley, Nature's Valley, Bohemia, NY) 300 mg, 2 capsules 3 times daily; (2.) folic acid, (countering potential deficiency that functions as a co-carcinogen) 800 micrograms, 6 tablets, 3 times daily (Life Extension Boca Raton, FL); and (3.) phosphatidyl choline (a hydrophilic surfactant), 1.2 grams, 6 capsules, 3 times daily (Carlson Laboratories,

Arlington Heights, IL), with its in-vitro anticancer effect of 88%. (4.)Plant derived

Cytoplasmic nuclear inhibitory factor, with the use of ½ carrot, ½ celery prepared in a blender as a juice, thereby releasing this cytoplasmic factor with natural beta carotene; 36 ounces.

Plant derived Cytoplasmic Factor that has a nuclear inhibitory effect, suppresses mitosis in cancer, is ½ fresh carrots and ½ celery prepared in a juicer as a beverage to be given as 36 ounce glasses, 3 times daily.

Case 35: Immunotherapeutic response and disease resolution of the most resistant infections of E.coli septicemia:

A patient in his late 70s documented as a post-operative complication of E.coli septicemia with a 50% mortality rate, a complication following surgical removal of gangrenous gallbladder septicemia cholecysitis and cholelithiasis and also effective in regard to resistant fungal infections. The addition of riboflavin l OOmg daily produced prompt clinical response of relief of fatigue and improvement and well being in addition to Clindamycin and Azactam intravenously as a out patient over three weeks. This treatment was based on an animal model of experimental septicemia (Azactam 2 grams daily and Clindomycin .9 grams reduced to .6 every eight hours this was required for sixteen days) in the mouse with a 90% mortality rate which was improved to a 10% mortality rate with the use of riboflavin (B2). These observations were further based upon animal model responses with the bio-material component composition of the immunotherapeutics of the subject and related applications that further includes viral, fungal, protozoa and other foreign organisms infectious disease reversal.

The bioelectric phenomena present in all tissue, is highly dependent upon subject compositions therapeutics organizational membrane matrix of phospholipid such as phosphatidyl choline and Omega-3 essential fatty acid fats (derived from fish oil and seed oils such as flax seed oil) found concentrated in this layer. The 3 alternating double bonds of the Omega-3 fatty acid fats generate a very similar pi electron cloud as the benzene ring but with out the toxicity of benzene and benzene ring compounds. The biologic competition that arc tissue integrity and innate immunity provide equivalent to 6,974,796 Bl is explained by the ability of omega three fatty acid fats (such as fish oil and seed oil) to hold oxygen in our cell membranes where the oxygen acts as a barrier to micro-organisms such as fungi, viruses, bacteria and other foreign organisms that can not thrive in its presence. Animal studies have shown that this adds to the omega three fatty acid fats ability to kill malaria based on animal studies and successful use as we have shown here in the treatment of staph bacterial infections including antibiotic resistance staph infections. The omega three fatty acid fats are also helpful and involved in making oxygen available to out tissues by activating oxygen molecules by way of their electrostatic forces. This biologic infectious disease protective competition is further explained in that the micro-organisms for the most part are anaerobic similar to cancer tissue, where as normal tissue functions at a aerobic level with ten times more oxygen utilization and energy release that the foregoing abnormal disease cell line.

These 3 alternating double bonds have the added safety and effective advantages in that this effect is similar to the safety found in the aromatic amino acids (tyrosine, tryptophan and phenylalanine) compatible with this 3-D stereo fit of all amino acids into protoplasmic protein cell biology models and of human and mammalian tissue. This is in contrast to the sliding action of one chemical upon the other in the cause of benzene ring compounds other than these biologic exceptions. They additionally move as delocalized pi electron bonds along the chain of the fatty acid. These electron clouds can form phase boundary potentials like the charges of static electricity in a capacitor. This bio electric capacitor is best exemplified by the phospholipids such as, phosphatidyl choline bilamellar liquid crystal micelle. This static electrical charge on the hydrophilic bilamellar outside layers creates this capacitor static electrical storage effect with the lipid hydrophobic insulating effect separation. This biologic competitive edge to disease cell lines is also seem with a highly sulfated extracellular matrix glycoproteins and monomers such as chondroitin sulfate and glucosamine sulfate. A further competitive edge is seen in that all L-amino acids of human and mammalian tissue specified by the genetic code of human tissue are L or non-chiral glycine whereas micro-organisms amino acids have D amino acids.

This biologic competitive edge to disease cell lines is seen in the cell membrane of phosphatidyl choline of human and mammalian tissue whereas micro-organisms have no phosphatidyl choline.

This biologic competitive edge to disease cell lines is also seen with the advantages of selenium in countering virulent influenza strains as additional findings of the advantages of normal selenium levels in reducing the risk of cancer

(Case 36: Immunotherapeutic response and disease resolution of the most resistant infections of resistant staphylococcus: A woman in mid 70s with a second bout of antibiotic resistance Staph. Aureus infection in her left groin which was acutely inflamed, tender and swollen. She responded promptly with therapeutic subject composition as reported in the patent office declaration in addition to the same therapeutic composition as the transdermal cream around the wound and 2% mupirocin for dermatologic use (Teva Pharmaceuticals, Israel and Sellersville, PA.). This rapidly improved with drainage of 5-10 cc of purulent grey-green viscous drainage fine linear drainage point that sealed spontaneously. Progressive improvement over 7-10 days. This effect was associated with expedient recovery and achieving symptom free status in 24/48 hours in contrast to the same lesion that occurred two years ago and was surgically drained and required hot baths and home nursing care for several weeks. Resistance staph manifested by an abscess in the left vulvar (5-6 cm in diameter) area not responsive to erythromycin ointment and erythromycin orally (supplied respectively by Abbott Pharmaceutical Company, Chicago, II. as erythromycin ointment and erystat 333mg bid) This occurred in a female patient in her late 70 's whose healing capacity was compromised by coexistent Crohn's disease and the need for cortico- steroids the aristocort ½ of 4mg tablet was reduced daily to a ½ a tablet three times weekly lessening the interference of healing. She responded to the transdermal treatment around the wound, warm compresses followed by mupirocin (Teva Pharmaceuticals) and 6,974,796 Bl therapy (same as the treatment used in the declaration). After 48-72 hours of treatment the abscess drained from an open about 1/3 of a centimeter in size, about lOcc of frank purulent of a grayish/green color.

This continued to drain (a few cc of diluted bloody drainage from the granulation tissue).

After a week of the foregoing treatment the tissues returned to normal without any drainage.

Two-three years ago patient required surgical care and drainage for a similar problem. Patient at this time refused surgical care due to the pain involved with the past surgical drainage and gave permission to use the foregoing treatment which she responded excellently to.

Treatment is presented in the literature in providing successful treatment for resistance staph.

This has been effective in 50% of patients without the advantage of this complete therapeutic approach.

In our research regarding nutrient deficiency in viral diseases such as influenza I found micronutrient deficiencies of selenium and zinc. Perhaps these micronutrieiit deficiencies might be considered by your attending doctor contained in such over-the-counter capsules as Carlson, Super 2 Daily, Arlington Heights, IL. (selenomethionine 200mcg and zinc gluconate 15mg). Treatment included in the synergy of the subject composition mimicking human tissue and human tissue healing capacity to be included with above zinc and selenium.

Case 37: Pain management in helping with pain resolution in peripheral neuropathy: The male patient, a scientist, age 57, incurred an accident when age 30. He was playing ice hockey in Canada and he was bent in half as a goalie by another player who came crashing in and compressed his L4/L5 vertebra disc compression at age 30 against the metal frame of the hockey goal post. The past four years it has been observed by x-ray and MRI that he has a crushed vertebral disk, which has been the cause of his bi-lateral pain especially on the left side. In the past year he has been awakened every night in pain and he has an abnormal sensation of numbness and coldness in both feet has progressively improved since he has been using this transdermal cream one to two times per day particularly at bedtime.

With the use of the transdermal cream, his nocturnal pain cleared and did not waken him 5 out of the 7 night. The transdeπnal cream as described in GIR 114P was used but one change was made in the formulation CVS 40% zinc oxide (CVS Pharmacy, Inc. Woonsocket, RI) was used as a substitute for A+D plus zinc oxide cream (Schering-Plough HealthCare

Products, Memphis, TN) (CVS 40% zinc oxide, BHA, cod liver oil, fragrance, lanolin, methylparaben, petrolatum, talc, water). The cream was used on feet (the left foot being more painful then the right foot).

● Treatment Contingency: comparison is based on 5 out of 7 days no pain, 2 of the 7 days there was pain: 2 days of nocturnal pain and 5 days pain free. Fisher's exact test used

● Treatment Contingency: comparison is based on 200 days of pain and 100 days pain free

● Treatment 100 days without pain: Significant 0.049 Probability Factor (P factor) when this data point is less than .05 it has clinical significance

A. Transdermal cream to spine by applying cream to damaged and disintegrate indivertible disc between L4/L5 and associated peripheral nerve roots locally on his back. Lay with Pillow under abdomen (optional as tolerated) to hyperextend his lumber sacral arch and cream is applied to this area with added features of making the spaces widen so that the cream will get to those areas compressed by the injuries (L4/L5 disc was disintegrate).

B. Applying the cream externally with added advantage of traction (hanging from chining bar or tilt table (inversion table, Kcttler) to pull the disc apart) put the cream on before and during this traction so that the cream can penetrate and permeate the area that we are directing to the lumber sacral arch L4/L5.Case 38: Pain management in helping with pain resolution in proctitis:

Male patient in early 80s after a flare-up of diarrhea of about two weeks developed moderately severe rectal pain after a bowel movement and perianal burning with the use of a nickel size drop of cream (more than one centimeter) transdermal cream applied to the toilet tissue with several applications to the perianal area with mild pressure at the site of the perianal canal. The patient had significant rapid relief of burning itching perianal discomfort as well as resolution of pain within a period of 15 minutes in regard to the acute protitis. With a diet of boiled rice, apple sauce, tea and toast the diarrhea cleared and the discomfort cleared. The cream was reapplied several days after each BM with resolution of per anal discomfort as well as more severe pain of proctitis. This inventive therapeutics disease resolution practicalizes this therapeutics for the common associated complication of IBD (Crohn's and ulcerative colitis of severe proctitis) and the dramatic disease resolution based on simplistic topical transdermal therapeutics.

Case 39: Pain management and acute gout: 80 year old male patient with gout with uric acid blood levels of greater that 8 milligrams percent. The following NSAID Advil gel (200 mg the capsule was opened and expressed, Wyeth Consumer Healthcare, Madison NJ) and was added to the transdermal cream. In the acute symptoms of gout of the right great toe metatarsal joint, swelling, pain, redness and heat were greatly improved. In the same case for future flare-up the following Naproxen is added to the transdermal cream and is expected to produce the same relief. However, advantageously (naprosyn suspension 125mg/5cc, l-2.5cc Roxanc Laboratories, Columbus, OH) were applied locally) in the acute symptoms of gout of the right great toe metatarsal joint, swelling, pain, redness and heat is greatly improved. Naproxen (naprosyn) has the advantage of the least side effects (GI CNS with the greatest anti -inflammatory activity and therefore one of the four cardinal signs of inflammation being pain 20 times more potent than aspirin as an anti-inflammatory cycloxygenase inhibitor then aspirin, ibuprofen and fenoprofen)

TABLE 1A

TABLE 1 B

TABLE 1C

TABLE 2A

TABLE 2B

TABLE 2C

TABLE 3D

Anti-Cancer In Vitro Therapeutic Trial Statistics

Notes on Table 4:

-Free amino acid molar ratio of targeted protein specified by the genetic code, matrix compact disc (CD) software.

--Swiss protein homo sapiens search profile based upon molar ratio of therapeutic formulation revealed.

—Penicillin insensitive protein ranked number one corresponding to the innate immunity protecting the bowel from E. coli dissemination. (The first six rank proteins were almost identical).

Claims

CLAIMS I claim:

1. A method for observing the birefringence of tissue treated with an anabolic medicament comprising a plurality of amino acids having an alpha carbon, the amino acids being present at a molar ratio which is characteristic of the targeted protein such as human breast milk protein, such as bowel protein, such as the skin, and wherein no more than 10% of the amino acids are in D-form and extracellular matrix cellular scaffolding selected from the group consisting of a glycosaminoglycan, a collagen, cartilage, chondroitin sulfate, heparan sulfate, dermatan sulfate, deratin sulfate, hyaluronic acid, a glycoprotein, and a proteoglycan, wherein said method comprises, obtaining a sample of treated tissue; securing the tissue sample for observation with a polarizing light microscope; obtaining birefringence light signals from the tissue; transmitting the birefringence light signals to a digital display device for observation.

2. A method for detecting mutagenic changes in a tissue or mutagenic potential of a treatment agent as a replication of tissue treated with an anabolic medicament that comprises: a) at least one extracellular matrix compound in an amount effective in the damaged tissue as anti-inflammatory and anti-neoangiogenetic agent, wherein said extracellular matrix compound is selected from the group consisting of a glycosaminoglycan, a collagen, cartilage, chondroitin sulfate, heparan sulfate, dermatan sulfate, deratin sulfate, hyaluronic acid, a glycoprotein, and a proteoglycan; b) at least one polar surface active lipid, wherein said polar surface active lipid is selected from the group consisting of a phospholipid, a glycolipid and a lipoprotein; and c) a plurality of amino acids having an alpha carbon, the amino acids being present at a molar ratio which is characteristic of human breast milk protein, and wherein no more than 10% of the amino acids are in D-form, wherein said method comprises, obtaining a sample of treated tissue; subjecting the tissue sample to polarizing light to obtain associated birefringence light signals; transmitting the birefringence light signals to a digital display device for observation and computer readout report .

3. The method, according to claim 2, wherein polarizing light fiber optic cable is utilized to transmit the birefringence crystal light signals to a digital display device.

4. The method, according to claim 3, wherein the digital display device further comprises software capable of analyzing the birefringence light signals.

5. The method, according to claim 4, wherein the birefringence light signals include information regarding spindle formation of cells.

6. The method, according to claim 5, wherein an in-vivo or therapeutic replication of tissue tissue sample is subjected to polarizing light.

7. The method, according to claim 5, wherein an in-vitro tissue sample is subjected to polarizing light.

8. The method, according to claim 7, wherein the tissue sample is maintained at a temperature approximately equivalent to the body tissue of the associated organism.

9. The method, according to claim 7, wherein the tissue or therapeutic replication of tissue sample is maintained at 37°C during analysis.

10. The method, according to claim 6, wherein a non-invasive probe is utilized to obtain birefringence light signals.

11. A device for detecting mutagenic changes in a tissue, said device comprising: a polarizing light probe for subjecting a tissue sample to polarizing light and obtaining the associated birefringence luminescence signals; a polarizing fiber optic cable operably connected to the polarizing light probe; a digital display device operably connected to the polarizing fiber optic cable for observation of the birefringence light signals.

12. The device, according to claim 11, wherein the polarizing light probe is heated.

13. The device, according to claim 1 1 , further comprising software capable of analyzing the birefringence light signals transmitted to the digital display device.

14. The device, according to claim 11, wherein the polarizing light penetrates the tissue sample to a depth of least 100 microns.

15. The device, according to claim 11, adaptable to clinical setting visualization requirements such as endoscopy, surgery, surgical subspecialties such as neurosurgery

16. The device, according to claim 15, wherein the adaptation includes use with a dissecting microscope.

17. The device, according to claim 11, for use in assessing wound or disease biomarkers of health or disease tissue.

18. The device, according to claim 17, further comprising use to assess tissue deficiency states.

19. The device, according to claim 18, further comprising a use to assess tissue deficiency states and associated biomarkers

20. A method for observing the birefringence of tissue or its therapeutic replication, wherein said method comprises, treated with an anabolic medicament comprising: obtaining a sample of treated tissue or tissue replication ; securing the tissue sample for observation with a polarizing light microscope; obtaining birefringence light signals from the tissue transmitting the birefringence light signals to a digital display device for observation, wherein said tissue has been treated with an anabolic medicament comprising a) at least one extracellular matrix compound in an amount effective in the damaged tissue as anti-inflammatory and anti-neoangiogenetic agent, wherein said extracellular matrix compound is selected from the group consisting of a glycosaminoglycan. a collagen, cartilage, chondroitin sulfate, heparan sulfate, dermatan sulfate, deratin sulfate, hyaluronic acid, a glycoprotein, and a proteoglycan; b) at least one polar surface active lipid, wherein said polar surface active lipid is selected from the group consisting of a phospholipid, a glycolipid and a lipoprotein; and c) a plurality of amino acids having an alpha carbon, the amino acids being present at a molar ratio which is characteristic of human breast milk protein, and wherein no more than 10% of the amino acids are in D-form.

21. The method, according to claim 20, further comprising comparing the light signals obtained for said sample to to light signals obtained from normal untreated tissue samples and/or untreated diseases tissues to determine if said anabolic medicament is mediating a therapeutic effect.

22. The method, according to claim 20, wherein the extracellular matrix compound is synthetically produced.

23. The method, according to claim 20, wherein said extracellular matrix compound is obtained from a cellular or tissue source.

24. The method, according to claim 23. wherein said cellular or tissue source is selected from the group consisting of a cell membrane, a tissue and an organ.

25. The method, according to claim 23, wherein said polar surface active lipid is obtained from a cellular or tissue source.

26. The method, according to claim 25, wherein said cellular or tissue source is selected from the group consisting of a cell membrane, a tissue, and an organ.

27. The method, according to claim 25, wherein the compsition at least one extracellular matrix compound, at least one polar surface active lipid, and at least one amino acid associate through a molecular bonding force.

28. The method, according to claim 25, wherein said molecular bonding force is selected from the group consisting of van der Waals force and ionic interaction.

29. The method, according to claim 27, wherein said molecular bonding force is selected from the group consisting of van der Waals force and ionic interaction group consisting of non-covalent bonding forces representing the body's bonding forces.

30. The method, according to claim 25, wherein the medicament further comprises at least one of (a) a mineral; (b) a vitamin; (c) an antioxidant; (d) an omega-3 oil; (e) zinc;(f) zinc oxide; (g) Vitamin A; (h) chondroitin sulfate; (i) cartilage; and (j) collagen.

31. The method to produce a composition, according to claim 20, wherein said polar surface active lipid is synthetically produced.

32. The method, according to claim 20, wherein said is composition of plurality of amino acids are obtained from a cellular or tissue source.

33. The method, according to claim 32, wherein said composition is a composition of cellular or tissue source is selected from the group consisting of a cell membrane, a tissue, and an organ.

34. The method, according to claim 20, further comprising a sterile vehicle.

35. The method, according to claim 20, wherein said medicament further comprises at least one of (a) a mineral; (b) a vitamin; (c) an antioxidant; (d) an omega-3 oil; (e) zinc;(f) zinc oxide; (g) Vitamin A; (h) chondroitin sulfate; (i) cartilage; and (j) collagen. (k.) folic acid, (1) 5 methyltetrahydrofolate

36. The method, according to claim 20, further comprising gamma amino butyric acid or L-carnitine.

37. The method, according to claim 20, further comprising a fatty acid selected from the group consisting of linoleic acid , linolenic acid and omega 3 fatty acid as fish or seed oil.

38. The method to produce a composition, according to claim 20, wherein the damaged tissue is selected from the group consisting of skin, eye, liver, gastrointestinal organ, kidney neurologic, and lung.

39. The method, according to claim 38, wherein the gastro-intestinal organ is bowel tissue.

40. The method, of claim 39, wherein the bowel tissue is damaged from regional ileitis (Crohn's Disease), inflammatory bowel disease, ulcerative colitis, or mucous colitis irritable bowel syndrome (IBS).

41. An anabolic medicament for treating a damaged tissue, the medicament comprising: a) at least one extracellular matrix compound in an amount effective in the damaged tissue as anti-inflammatory and anti-neoangiogenetic agent, wherein said extracellular matrix compound is selected from the group consisting of a glycosaminoglycan, a collagen, cartilage, chondroitin sulfate, heparan sulfate, dermatan sulfate, , hyaluronic acid, a glycoprotein, and a proteoglycan; b) at least one polar surface active lipid, wherein said polar surface active lipid is selected from the group consisting of a phospholipid, a glycolipid and a lipoprotein; and c) a plurality of amino acids having an alpha carbon, the amino acids being present at a molar ratio which is characteristic of human breast milk protein, and wherein no more than 10% of the amino acids are in D-form.

42. The medicament according to claim 41, wherein said extracellular matrix compound is synthetically produced.

43. The medicament according to claim 41, wherein said extracellular matrix compound is obtained from a cellular or tissue source.

44. The medicament according to claim 43, wherein said cellular or tissue source is selected from the group consisting of a cell membrane, a tissue and an organ.

45. The medicament according to claim 41, wherein said polar surface active lipid is obtained from a cellular or tissue source.

46. The medicament according to claim 45, wherein said cellular or tissue source is selected from the group consisting of a cell membrane, a tissue, and an organ.

47. The medicament according to claim 45, wherein at least one extracellular matrix compound, at least one polar surface active lipid, and at least one amino acid associate through a molecular bonding force.

48. The medicament according to claim 47, wherein said molecular bonding force is selected from the group consisting of van der Waals force and ionic interaction.

49. The medicament according to claim 45 further comprising at least one of (a) a mineral; (b) a vitamin; (c) an antioxidant; (d) an omega-3 oil; (e) zinc;(f) zinc oxide; (g) Vitamin A; (h) chondroitin sulfate; (i) cartilage; and (J) collagen.

50. The medicament according to claim 41, wherein said polar surface active lipid is synthetically produced.

51. The medicament according to claim 41, wherein said plurality of amino acids are obtained from a cellular or tissue source.

52. The medicament according to claim 51, wherein said cellular or tissue source is selected from the group consisting of a cell membrane, a tissue, and an organ.

53. The medicament according to claim 41 , further comprising a sterile vehicle.

54. The medicament according to claim 41 further comprising at least one of (a) a mineral; (b) a vitamin; (c) an antioxidant; (d) an omega-3 oil; (e) zinc;(f) zinc oxide; (g) Vitamin A: (h) chondroitin sulfate; (i) cartilage; and (j) collagen.

55. The medicament according to claim 41, further comprising gamma amino butyric acid or L-carnitine.

56. The medicament according to claim 41 further comprising a fatty acid selected from the group consisting of linoleic acid and linolenic acid.

57. The medicament of claim 41, wherein the damaged tissue is selected from the group consisting of skin, eye, liver, gastrointestinal organ, kidney, and lung.

58. The medicament of claim 57, wherein the gastro-intestinal tissue is bowel tissue.

59. The medicament of claim 58, wherein the bowel tissue is damaged from regional ileitis (Crohn's Disease), inflammatory bowel disease, ulcerative colitis, mucous colitis, irritable bowel syndrome and further include celiac disease because of mechanisms herein of improving abnormal intestinal permeability.

60. A plurality of amino acids having an alpha carbon, the amino acids being present at a molar ratio which is characteristic of the targeted protein such as human breast milk protein, such as bowel protein, such as the skin, and wherein no more than 10% of the amino acids are in D-form and extracellular matrix cellular scaffolding selected from the group consisting of a glycosaminoglycan, a collagen, cartilage, chondroitin sulfate, heparan sulfate, dermatan sulfate, deratin sulfate, hyaluronic acid, a glycoprotein, and a proteoglycan.

61. A composition comprising a plurality of free amino acids having an alpha carbon, said composition comprising a plurality of amino acids specified by the genetic code contained in a target protein and extracellular matrix cellular scaffolding selected from the group consisting of a glycosaminoglycan, a collagen, cartilage, chondroitin sulfate, heparan sulfate, dermatan sulfate, deratin sulfate, hyaluronic acid, a glycoprotein, and a proteoglycan.

62. A composition, according to claim 61, for use as an anti-inflammatory.

63. A composition, according to claim 61, for use as an immunological privileged, healing stem cell stimulant.

64. A composition, according to claim 61, for use as a growth factor.

65. A composition, according to claim 61, for use as an immunotherapeutic.