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A method for isolating tissue repair promoting substances from human or animal blood which comprises collecting the human or animal blood from a single human or animal individual in a first container of a container system comprising at least a first and second interconnected containers; centrifuging the container system containing the blood so as to separate the blood in various fractions including a plasma fraction; transferring at least part of the plasma fraction to the second container of the container system; subjecting the plasma fraction in the second container to a low temperature so as to obtain a precipitate comprising tissue repair promoting substances; concentrating the precipitate in the second container so as to obtain a first fraction comprising a major part of the non-precipitated material; and separating the second fraction comprising the tissue repair promoting substances from said first fraction within the second container; and optionally heating the second...

Inventeur: Ulla S. Weis-Fogh
Examinateur principal: Jean C. Witz
Classification américaine actuelle: 424/529; 424/530; 424/531; 424/532; 424/533; 424/534; 514/2; 514/21
Classification internationale: A61K 3514; A61K 3516

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Citations

Brevet cité Date de dépôt Date de délivrance Cessionnaire d'origine Titre
US27102942 nov. 19531955BLOOD FRACTIONATION
US32230839 sept. 19601965METHOD FOR ADHESIVELY SECURWG
US38700426 oct. 19721975APPARATUS FOR SEPARATING AND INJECTING BLOOD COMPONENT
US42985984 févr. 19803 nov. 1981Immuno Aktiengesellschaft fur chemisch-medizinische ProdukteTissue adhesive
US43417645 mars 198027 juil. 1982Cutter Laboratories, Inc.Method of preparing fibronectin and antihemophilic factor
US43775727 juil. 198122 mars 1983Immuno Aktiengesellschaft fur Chemisch-Medizinische ProdukteTissue adhesive
US441497613 sept. 198215 nov. 1983Immuno Aktiengesellschaft fur chemischmedizinische ProdukteTissue adhesive
US460817819 déc. 198426 août 1986Method of separating blood components
US46082547 mars 198426 août 1986Immuno Aktiengesellschaft fur chemisch-medizinische ProdukteMethod for the production of therapeutically administrable plasma derivatives filled in final containers
US471445715 sept. 198622 déc. 1987Method and apparatus for use in preparation of fibrinogen from a patient's blood
US476013123 juin 198626 juil. 1988Collagen CorporationWound-healing composition

Revendications

1. A method of isolating tissue repair promoting substances from human or animal blood comprising:

(a) aseptically collecting a blood sample from a single human or animal into a sealable sterilized container system;
(b) sealing the container system so that contaminants in the environment are excluded;
(c) preparing tissue repair promoting substances from the blood sample by processing the sample within the sealed container system, the processing comprising:
(i) separating the blood sample into a plurality of fractions including a plasma fraction and a platelet-containing plasma fraction;
(ii) precipitating tissue repair promoting substances from the plasma fraction by subjecting the plasma fraction to precipitation-promoting conditions, the precipitation-promoting conditions comprising incubation of the plasma fraction with a precipitation-promoting agent at a temperature at which precipitation occurs, and separating the precipitate which contains the tissue repair promoting substances from unprecipitated materials;

(iii) subjecting the platelet-containing fraction to conditions which promote the release of tissue repair promoting substances from the platelets and separating the releasate from cells and cell debris; and
(iv) combining the precipitate obtained from the plasma fraction with the releasate obtained from the platelet-containing fraction.

2. The method of claim 1 wherein the precipitation-promoting agent is a lower alkanol.

3. The method of claim 2 wherein the lower alkanol is ethanol.

4. The method of claim 1, 2 or 3 wherein the tissue repair promoting substances are precipitated from the plasma fraction at a temperature from -3.degree. C. to 10.degree. C.

5. The method of claim 1 wherein the container system comprises a collection container for receiving the blood sample, and the method comprises the additional step of introducing an anticoagulant into the collection container before the blood sample is transferred into the collection container.

6. The method of claim 5 comprising the additional step of introducing a proteolytic enzyme inhibitor into the collection container before the processing of the blood sample begins.

7. The method of claim 1 wherein the release promoting conditions include contacting the platelet-containing fraction with a substance which promotes growth factor release from platelets.

8. The method of claim 7 wherein the substance is selected from the group consisting of adenosine diphosphate, adrenalin, thrombin and collagen.

9. The method of claim 1 wherein all reagents used in the processing of the blood sample are introduced into the container system before the blood sample is introduced therein.

10. The method of claim 1 wherein more than 60% of the fibrinogen present in the blood sample is recovered.

11. A method of promoting the repair of a tissue of a human or animal comprising:

(a) aseptically collecting a blood sample from a single human or animal into a sealable sterilized container system;
(b) sealing the container system so that contaminants in the environment are excluded;
(c) preparing tissue repair promoting substances from the blood sample by processing the sample within the container system, the processing comprising:
(i) separating the blood sample into a plurality of fractions including a plasma fraction and a platelet-containing plasma fraction;
(ii) precipitating tissue repair promoting substances from the plasma fraction by subjecting the plasma fraction to precipitation-promoting conditions, the precipitation-promoting conditions comprising incubation of the plasma fraction with a precipitation-promoting agent at a temperature at which precipitation occurs, and separating the precipitate which contains the tissue repair promoting substances from unprecipitated materials to obtain an aseptic tissue repair promoting composition;
(iii) subjecting the platelet-containing fraction to conditions which promote the release of tissue repair promoting substances from the platelets and separating the releasate from cells and cell debris;
(iv) combining the precipitate obtained from the plasma fraction with the releasate obtained from the platelet-containing fraction; and
(d) applying the tissue repair promoting composition to the tissue of the human or animal.

12. The method of claim 11 wherein the precipitation-promoting agent is a lower alkanol.

13. The method of claim 12 wherein the lower alkanol is ethanol.

14. The method of claim 11, 12 or 13 wherein the tissue repair promoting substances are precipitated from the plasma fraction at a temperature from -3.degree. C. to 10.degree. C.

15. The method of claim 11 wherein the container system comprises a collection container for receiving the blood sample, and the method comprises the additional step of introducing an anticoagulant into the collection container before the blood sample is transferred into the collection container.

16. The method of claim 15 comprising the additional step of introducing a proteolytic enzyme inhibitor into the collection container before the processing of the blood sample begins.

17. The method of claim 11 wherein the release promoting conditions include contacting the platelet-containing fraction with a substance which promotes growth factor release from platelets.

18. The method of claim 17 wherein the substance is selected from the group consisting of adenosine diphosphate, adrenalin, thrombin and collagen.

19. The method of claim 11 wherein all reagents used in the processing of the blood sample are introduced into the container system before the blood sample is introduced therein.

20. The method of claim 11 wherein more than 60% of the fibrinogen present in the blood sample is recovered.

21. The method of claim 11 wherein the tissue repair promoting compositions is applied to the tissue by means of a device comprising a first reservoir associated with a first piston means which contains the tissue repair promoting composition and a second reservoir associated with a second piston means which contains a substance that catalyzes conversion of fibrinogen to fibrin, the first and second piston means of the device being operably linked so that the tissue repair promoting composition and the catalytic substance are simultaneously expelled and conducted to the tissue of the human or animal.