Claims
- 1. A process for preparing a hypoimmunogenic composition suitable for implantation to effect bone repair in a vertebrate
- wherein the composition comprises an osteoinductively effective amount of a protein osteoinductive factor (OF), which OF is sufficiently pure to be hypoimmunogenic in a xenogeneic host, and a carrier having components which consist essentially of mineral constituting 60-98% and collagen constituting 2-40% of the composition,
- which process comprises:
- (a) preparing a uniform suspension in water of the collagen, mineral, and OF components of the composition so that the concentration of collagen in the suspension is 30-100 mg/ml; and
- (b) subjecting the suspension to controlled drying under ambient pressure to obtain a rigid solid.
- 2. The process of claim 1 wherein the carrier is 75-95% mineral and 5-25% of collagen.
- 3. The process of claim 1 wherein the drying is conducted in air at a temperature of 1.degree.-40.degree. C.
- 4. The process of claim 1 wherein the drying is conducted in air at a temperature of 15.degree.-37.degree. C.
- 5. The process of claim 1 wherein the drying is continued until the solid has a compressive modulus of at least 20N/cm.sup.2.
- 6. The process of claim 1, which further includes heat curing of the product of (b).
- 7. The process of claim 6 wherein the heat curing is conducted until the solid has a compressive modulus of at least 50N/cm.sup.2.
- 8. The process of claim 6 wherein the heat curing is conducted at 50.degree.-120.degree. C. for 4-168 hours.
- 9. The process of claim 1 wherein the suspension of (a) is prepared by mixing a dilute solution of OF with mineral particles, drying the mixture, and mixing the dried mixture with reconstituted atelopeptide fibrillar collagen suspension containing 30-100 mg/ml of collagen.
- 10. The process of claim 9 wherein the mixture of the solution of OF and mineral particles is dried by air drying.
- 11. The process of claim 9 wherein the mixture of the solution of OF and mineral particles is dried by lyophilization.
- 12. The process of claim 1 wherein the suspension of (a) is prepared by adding a solution of OF to collagen in solution, precipitating the collagen and OF, resuspending the precipitate to a collagen concentration of 30-100 mg/ml, and then mixing the resulting suspension with mineral particles.
- 13. A bone repair composition prepared according to the process of claim 1.
- 14. A bone repair composition prepared according to the process of claim 2.
- 15. A bone repair composition prepared according to the process of claim 6.
- 16. A hypoimmunogenic composition suitable for implantation to effect bone repair in a vertebrate, which consists essentially of 60-98% mineral particles; 2-40% of atelopeptide hypoimmunogenic collagen; and an effective amount of an OF preparation,
- wherein the implant is a porous rigid solid of compressive modulus greater than 20N/cm.sup.2, is homogeneous with respect to its components, and wherein the OF is in a biologically active and available form.
- 17. The composition of claim 16 having a compressive modulus greater than 50N/cm.sup.2.
- 18. The composition of claim 16 wherein the effective amount of OF preparation is 0.5%-4% of partially purified OFE or its equivalent.
- 19. The composition of claim 18 wherein the effective amount of OF preparation is 0.5%-4% of partially purified OFE.
- 20. The composition of claim 16 wherein the composition consists essentially of 75-95% mineral particles; 5-25% of atelopeptide hypimmunogenic collagen; and an effective amount of an OF preparation.
Parent Case Info
This is a continuation-in-part of U.S. Ser. No. 816,268 filed 6 Jan. 1986 which is a continuation-in-part of U.S. Ser. No. 664,158, filed 10/24/84, now U.S. Pat. No. 4,563,350, issued 7 Jan. 1986.
US Referenced Citations (5)
Non-Patent Literature Citations (2)
Entry |
Urist et al, "Purification of Bovine Bone Morphogenetic Protein by Hydroxy-Apatite Chromatography", Proc. Natl. Acad. Sci. USA, Jan. 1984, vol. 81, pp. 371-375. |
Termine et al, "Mineral and Collagen-Binding Proteins of Fetal Calf Bone", J. Biol. Chem., vol. 256, No. 20, Oct. 25, 1981, pp. 10403-10408. |
Continuation in Parts (2)
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Number |
Date |
Country |
Parent |
816268 |
Jan 1986 |
|
Parent |
664158 |
Oct 1984 |
|