CA2457372A1 - Composition for filling bone defects - Google Patents
Composition for filling bone defects Download PDFInfo
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- CA2457372A1 CA2457372A1 CA002457372A CA2457372A CA2457372A1 CA 2457372 A1 CA2457372 A1 CA 2457372A1 CA 002457372 A CA002457372 A CA 002457372A CA 2457372 A CA2457372 A CA 2457372A CA 2457372 A1 CA2457372 A1 CA 2457372A1
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L24/00—Surgical adhesives or cements; Adhesives for colostomy devices
- A61L24/0005—Ingredients of undetermined constitution or reaction products thereof
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
- A61K35/12—Materials from mammals; Compositions comprising non-specified tissues or cells; Compositions comprising non-embryonic stem cells; Genetically modified cells
- A61K35/32—Bones; Osteocytes; Osteoblasts; Tendons; Tenocytes; Teeth; Odontoblasts; Cartilage; Chondrocytes; Synovial membrane
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- A—HUMAN NECESSITIES
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K38/00—Medicinal preparations containing peptides
- A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
- A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
- A61K38/18—Growth factors; Growth regulators
- A61K38/1875—Bone morphogenic factor; Osteogenins; Osteogenic factor; Bone-inducing factor
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- A61L24/0073—Composite materials, i.e. containing one material dispersed in a matrix of the same or different material with a macromolecular matrix
- A61L24/0094—Composite materials, i.e. containing one material dispersed in a matrix of the same or different material with a macromolecular matrix containing macromolecular fillers
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- A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
- A61L27/36—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix
- A61L27/3604—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix characterised by the human or animal origin of the biological material, e.g. hair, fascia, fish scales, silk, shellac, pericardium, pleura, renal tissue, amniotic membrane, parenchymal tissue, fetal tissue, muscle tissue, fat tissue, enamel
- A61L27/3608—Bone, e.g. demineralised bone matrix [DBM], bone powder
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- A61L27/3683—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix subjected to a specific treatment prior to implantation, e.g. decellularising, demineralising, grinding, cellular disruption/non-collagenous protein removal, anti-calcification, crosslinking, supercritical fluid extraction, enzyme treatment
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- A61L27/3804—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix containing added animal cells characterised by specific cells or progenitors thereof, e.g. fibroblasts, connective tissue cells, kidney cells
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- A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
- A61L27/36—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix
- A61L27/38—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix containing added animal cells
- A61L27/3804—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix containing added animal cells characterised by specific cells or progenitors thereof, e.g. fibroblasts, connective tissue cells, kidney cells
- A61L27/3821—Bone-forming cells, e.g. osteoblasts, osteocytes, osteoprogenitor cells
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- A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
- A61L27/36—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix
- A61L27/38—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix containing added animal cells
- A61L27/3804—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix containing added animal cells characterised by specific cells or progenitors thereof, e.g. fibroblasts, connective tissue cells, kidney cells
- A61L27/3834—Cells able to produce different cell types, e.g. hematopoietic stem cells, mesenchymal stem cells, marrow stromal cells, embryonic stem cells
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- A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
- A61L27/36—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix
- A61L27/38—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix containing added animal cells
- A61L27/3839—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix containing added animal cells characterised by the site of application in the body
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- A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
- A61L27/40—Composite materials, i.e. containing one material dispersed in a matrix of the same or different material
- A61L27/44—Composite materials, i.e. containing one material dispersed in a matrix of the same or different material having a macromolecular matrix
- A61L27/48—Composite materials, i.e. containing one material dispersed in a matrix of the same or different material having a macromolecular matrix with macromolecular fillers
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- A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
- A61L27/50—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
- A61L27/52—Hydrogels or hydrocolloids
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- C—CHEMISTRY; METALLURGY
- C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
- C08L—COMPOSITIONS OF MACROMOLECULAR COMPOUNDS
- C08L5/00—Compositions of polysaccharides or of their derivatives not provided for in groups C08L1/00 or C08L3/00
- C08L5/08—Chitin; Chondroitin sulfate; Hyaluronic acid; Derivatives thereof
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
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- A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
- A61F2002/30003—Material related properties of the prosthesis or of a coating on the prosthesis
- A61F2002/30004—Material related properties of the prosthesis or of a coating on the prosthesis the prosthesis being made from materials having different values of a given property at different locations within the same prosthesis
- A61F2002/30059—Material related properties of the prosthesis or of a coating on the prosthesis the prosthesis being made from materials having different values of a given property at different locations within the same prosthesis differing in bone mineralization, e.g. made from both mineralized and demineralized adjacent parts
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- A61F2310/00—Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
- A61F2310/00005—The prosthesis being constructed from a particular material
- A61F2310/00359—Bone or bony tissue
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- A61L2430/00—Materials or treatment for tissue regeneration
- A61L2430/02—Materials or treatment for tissue regeneration for reconstruction of bones; weight-bearing implants
Abstract
The invention is directed toward a formable bone composition for application to a bone defect site to promote new bone growth at the site whi ch comprises a new bone growth inducing compound of demineralized lyophilized allograft bone particles: The particle size ranges from about 0.1 mm to abou t 1.0cm and is mixed in a hydrogel carrier containing a sodium phosphate salin e buffer, the hydrogel component of the carrier ranging from about 1.0 to 5.0% of the composition and a pH between 6.8-7.4 with one or more additives of a cellular material, growth factor, demineralized bone chips or mineralized bone chips.
Claims (18)
1. A sterile malleable bone composition for application to a bone defect site to promote new bone growth at the site comprising demineralized osteoinductive and osteoconductive bane particles in an aqueous carrier solution, the bone particles being added to a viscous carrier at a concentration ranging from 5-50%(w/w), the carrier comprising a hydrogel component of sodium hyaluronate or its derivatives in a phosphate buffered aqueous solution, said hydrogel ranging from about 1.0% to about 5.4% by weight of the aqueous carrier solution and cellular material taken from a group consisting of living cells, cell elements such as red blood cells, white blood cells, platelets, blood plasma, pluripotential cells, osteoblasts, osteoclasts, and fibroblasts, epithelial cells, and endothelial cells present at a concentration of 10 5 to 10 8 per cc of the carrier, said hydrogel component having a high molecular weight ranging from about six hundred sixty thousand to three million Daltons with a stable viscosity at a temperature ranging from about 22° C to about 37° C and said composition having a pH ranging from about 6.8 to about 7.4
2. A sterile formable bone composition as claimed in claim 1 wherein said bone particles are allograft cortical bone ranging from 100 microns to 850 microns in size at a concentration ranging from 20% to 35% by weight of the composition.
3. A sterile formable bone composition as claimed in claim 1 including growth factor additive added to said composition, said growth factor comprising one or more of a group consisting of transforming growth factor (TGF-beta), insulin growth factor (IGF-1); platlet derived growth factor (PDGF), vascular endothelial growth factor (VEGF), fibroblast growth factor (FGF) (numbers 1-23), osteopontin, growth hormones such as somatotropin cellular attractants and attachment agents.
4. A sterile formable bone composition as claimed in claim 1 including growth factor additive added to said composition comprising one or more of a group consisting of fibroblast growth factor (FGF) (numbers 1-23) in the amount of 2-4 milligrams in 10cc of carrier solution.
5. A sterile formable bone composition as claimed in claim 1 wherein said composition includes an additive collagen and insoluble collagen derivatives.
6. A sterile formable bone composition as claimed in claim 1 wherein said composition includes the addition of calcium hydroxyapatite at a concentration of 20-35%
measured as calcium.
measured as calcium.
7. A sterile formable bone composition as claimed in claim 1 wherein said bone particles are taken from a group consisting of allograft bone, cortical allograft bone, corticalcancellous bone, cancellous bone, autologous bone and xenograft bone
8. A formable bone composition as claimed in claim 1 wherein said composition includes hone chips taken from a group consisting of partially demineralized chips and non demineralized chips having a particle size ranging from 0.1 mm to 1.0cm which are added to said viscous carrier at a concentration of about 5% to about 25%.
9. A sterile formable bone composition for application to a bone defect site to promote new bone growth at the site comprising a demineralized osteoinductive and osteoconductive bone particles in an aqueous carrier solution, the bone particles being added to a viscous carrier at a concentration ranging from 5-50%(w/w), the carrier comprising a hydrogel component of sodium hyaluronate or its derivatives in a phosphate buffered aqueous solution, said hydrogel ranging from about 1.0% to about 5.0% by weight of the aqueous carrier solution and said hydrogel component having a high molecular weight ranging from about six hundred sixty thousand to three million Daltans with a stable viscosity at a temperature ranging from about 22°C to about 37°C, said composition having a pH ranging from about 6.8 to about 7.4 and a growth factor additive added to said composition, said growth factor comprising one or more of a group consisting of transforming growth factor (TGF-beta), insulin growth factor (IGF-1); platlet derived growth factor (PDGF), vascular endothelial growth factor (VEGF), fibroblast growth factor (FGF) (numbers 1-23), osteopontin, growth hormones such as somatotropin cellular attractants and attachment agents.
10. A formable hone composition as claimed in claim 9 including a cellular material taken from a group consisting of living cells and cell elements such as chondrocytes, red blood cells, white blood cells,platelets, blood plasma, bone marrow cells, mesenchymal stem cells, pluripotential cells, oste~asts, osteoclasts, and fibroblasts, epithelial cells, and endothelial cells.
These cells or cell elements or combinations of the same are present at a concentration of 10 5 to 8 per cc of the carrier
These cells or cell elements or combinations of the same are present at a concentration of 10 5 to 8 per cc of the carrier
11. A sterile formable bone composition for application to a bone defect site to promote new bone growth at the site comprising a demineralized osteoinductive and osteoconductive bone particles in an aqueous carrier solution, the bone particles being added to a viscous carrier at a concentration ranging from 5-50%(w/w), the carrier comprising a hydrogel taken from a group consisting of Dextran, carboxyethylcellulose (CMC) and hydroxypropylmethylcellulose (HPMC) in a phosphate buffered aqueous solution, said hydrogel ranging from about 15% to about 30% by weight of the aqueous carrier solution and said hydrogel component having a molecular weight ranging from twenty thousand to forty thousand Daltons with a stable viscosity at a temperature ranging from about 22°
C to about 37°C and said composition having a pH ranging from about 6.8 to about 7.4 and a growth factor additive added to said composition, said growth factor comprising one or more of a group consisting of transforming growth factor (TGF-beta), insulin growth factor (IGF-1); platlet derived growth factor (PDGF), vascular endothelial growth factor (VEGF), fibroblast growth factor (FGF) (numbers 1-23), osteopontin, growth hormones such as somatotropin cellular attractants and attachment agents.
C to about 37°C and said composition having a pH ranging from about 6.8 to about 7.4 and a growth factor additive added to said composition, said growth factor comprising one or more of a group consisting of transforming growth factor (TGF-beta), insulin growth factor (IGF-1); platlet derived growth factor (PDGF), vascular endothelial growth factor (VEGF), fibroblast growth factor (FGF) (numbers 1-23), osteopontin, growth hormones such as somatotropin cellular attractants and attachment agents.
12. A sterile formable bone composition as claimed in claim 11 including a cellular material additive taken from a group consisting of living cells and cell elements such as chondrocytes, red blood cells, white blood cells, platelets, blood plasma, bone marrow cells, mesenchymal stem cells, pluripotential cells, osteoblasts, osteoclasts, and fibroblasts, epithelial cells, and endothelial cells. These cells or cell elements or combinations of the same are present at a concentration of 10 5 to 10 8 per cc of the carrier
13. A sterile formable bone composition for application to a bone defect site to promote new bone growth at the site comprising demineralized osteoinductive and osteoconductive bone particles an aqueous carrier solution, the bone particles being added to a viscous carrier at a concentration ranging from 5-50%(w/w), the carrier comprising a hydrogel taken from a group consisting of Dextran, carboxymethylcellulose (CMC) and hydroxypropylmethylcellulose (HPMC) in a phosphate buffered aqueous solution, said hydrogel ranging from about 15% to about 30% by weight of the aqueous carrier solution and cellular material taken from a group consisting of living cells, cell elements such as red blood cells, white blood cells, platelets, blood plasma, pluripotential cells, osteoblasts, osteoclasts, and fibroblasts, epithelial cells, and endothelial cells present at a concentration of 10 5 to 10 8 per cc of the carrier, said hydrogel component having a molecular weight ranging twenty thousand to forty thousand Daltons with a stable viscosity and said composition having a pH ranging from about 6.8 to about 7.4
14. A sterile formable bone composition as claimed in claim 13 including growth factor additive added to said composition, said growth factor comprising one or more of a group consisting of transforming growth factor (TGF-beta), insulin growth factor (IGF-1); platlet derived growth factor (PDGF), vascular endothelial growth factor (VEGF), fibroblast growth factor (FGF) (numbers 1-23), osteopontin, growth hormones such as somatotropin cellular attractants and attachment agents.
15. A sterile formable bone composition for application to a bone defect site to promote new bone growth at the site comprising a demineralized osteoinductive and osteoconductive bone particles in an aqueous carrier solution, the bone particles being added to a viscous carrier at a concentration ranging from 5-50%(w/w), the carrier comprising a hydrogel taken from a group consisting of chitosan and sodium alginate in a phosphate buffered aqueous solution, said hydrogel ranging from about 5.0% to about 20.0% by weight of the aqueous carrier solution and said hydrogel component having a molecular weight ranging from ten thousand to three hundred thousand Daltons with a stable viscosity at a temperature ranging from about 22° C to about 37°C and said composition having a pH
ranging from about 6.8 to about 7.4 and a growth factor additive added to said composition, said growth factor comprising one or more of a group consisting of transforming growth factor (TGF-beta), insulin growth factor (IGF-1); platlet derived growth factor (PDGF), vascular endothelial growth factor (VEGF), fibroblast growth factor (FGF) (numbers 1-23), osteopontin, growth hormones such as somatotropin cellular attractants and attachment agents.
ranging from about 6.8 to about 7.4 and a growth factor additive added to said composition, said growth factor comprising one or more of a group consisting of transforming growth factor (TGF-beta), insulin growth factor (IGF-1); platlet derived growth factor (PDGF), vascular endothelial growth factor (VEGF), fibroblast growth factor (FGF) (numbers 1-23), osteopontin, growth hormones such as somatotropin cellular attractants and attachment agents.
16. A formable bone composition as claimed in claim 15 including a cellular material additive taken from a group consisting of living cells and cell elements such as chondrocytes, red blood cells, white blood cells, platelets, blood plasma, bone marrow cells, mesenchymal stem cells, pluripotential cells, osteoblasts, osteoclasts, and fibroblasts, epithelial cells, and endothelial cells. These cells or cell elements or combinations of the same are present at a concentration of 5 to 10 8 per cc of the carrier
17. A sterile malleable bone composition for application to a bone defect site to promote new bone growth at the site comprising demineralized osteoinductive and osteoconductive bone particles in an aqueous carrier solution, the bone particles being added to a viscous carrier at a concentration ranging from 5-50%(w/w), the carrier comprising a hydrogel taken from a group consisting of chitosan and sodium alginate in a phosphate buffered aqueous solution, said hydrogel ranging from about 5.0% to about 20.0% by weight of the aqueous carrier solution and cellular material taken from a group consisting of living cells, cell elements such as red blood cells, white blood cells, platelets, blood plasma, pluripotential cells, osteoblasts, osteoclasts, and fibroblasts, epithelial cells, and endothelial cells present at a concentration of 10 5 to 10 9 per cc of the carrier, said hydrogel component having a molecular weight ranging from ten thousand to three hundred thousand Daltons with a stable viscosity and said composition having a pH ranking from about 6.8 to about 7.4
18. A sterile formable bone composition as claimed in claim 17 including growth factor additive added to said composition, said growth factor comprising one or more of a group consisting of transforming growth factor (TGF-beta), insulin growth factor (IGF-1); platlet derived growth factor (PDGF), vascular endothelial growth factor (VEGF), fibroblast growth factor (FGF) (numbers 1-23), osteopontin, growth hormones such as somatotropic cellular attractant and attachment agents.
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
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PCT/US2003/023273 WO2004016297A1 (en) | 2002-08-19 | 2003-08-19 | Composition for filling bone defects |
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CA2457372C CA2457372C (en) | 2011-12-20 |
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EP (1) | EP1549358A4 (en) |
AU (1) | AU2003261248A1 (en) |
CA (1) | CA2457372C (en) |
WO (1) | WO2004016297A1 (en) |
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US7019192B2 (en) | 2006-03-28 |
US20020197242A1 (en) | 2002-12-26 |
US20040197373A1 (en) | 2004-10-07 |
EP1549358A1 (en) | 2005-07-06 |
AU2003261248A1 (en) | 2004-03-03 |
WO2004016297A1 (en) | 2004-02-26 |
EP1549358A4 (en) | 2008-07-16 |
CA2457372C (en) | 2011-12-20 |
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