Substantially non-immunogenic injectable collagen
The invention provides an article of manufacture comprising a substantially non-immunogenic injectable collagen for implantation into humans. The invention further provides methods for preparing injectable collagen material by removing collagen-containing material from a non-human animal; washing in saline and alcohol; subjecting material to cellular disruption treatment; and digesting the material with a proteoglycan-depleting factor and/or glycosidase and optionally following with a capping treatment. The invention also provides an article of manufacture produced by the method. The injectable collagen material of the invention are substantially non-immunogenic and have substantially the same mechanical properties as a corresponding native soft tissue.
1. A method of preparing a collagen-containing material for injection into a human, comprising:
A. removing at least a portion of a collagen-containing material from a non-human animal;
B. subjecting the collagen-containing material to a cellular disruption treatment;
C. digesting the collagen-containing material with a glycosidase to remove first surface carbohydrate moieties; and
D. establishing said collagen-containing material in a form of a liquid, colloid, semi-solid, suspended particulate, gel, or paste, and combinations thereof.
2. The method according to claim 1 comprising the further step of sterilizing said material.
3. The method according to claim 2 wherein said sterilization step includes irradiating said collagen-containing material with e-beam ionizing radiation.
4. The method according to claim 3 wherein said radiation is a dose approximately equal to 17.8 KGy.
5. The method according to claim 2 wherein said sterilization step includes irradiation of said collagen-containing material with gamma radiation in the amount 0.2 MegaRad to about 3 MegaRad.
6. The method according to claim 1 further comprising the steps of: Following glycosidase digestion, treating of carbohydrate moieties of the collagen containing material with capping molecules.
7. The method according to claim 1 wherein said cellular disruption treatment is selected from the group consisting of exposure to ultraviolet radiation, immersion in alcohol and/or freeze/thaw cycling.
8. A method of preparing a collagen-containing material for injection into a human, comprising:
A. removing at least a portion of a collagen-containing material from a non-human animal;
B. subjecting the collagen-containing material to a cellular disruption treatment;
C. treating said collagen-containing material with proteoglycan depleting factors to establish said collagen-containing material as having reduced proteoglycans; and
D. establishing said collagen-containing material in a form of a liquid, colloid, semi-solid, suspended particulate, gel, or paste, and combinations thereof.
9. The method according to claim 8 comprising the further step of sterilizing said material.
10. The method according to claim 9 wherein said sterilization step includes irradiating said collagen-containing material with e-beam ionizing radiation.
11. The method according to claim 10 wherein said radiation is a dose approximately equal to 17.8 KGy.
12. The method according to claim 9 wherein said sterilization step includes irradiation of said collagen-containing material with gamma radiation in the amount 0.2 MegaRad to about 3 MegaRad.
13. The method according to claim 8 further comprising the steps of: following said proteoglycan-depleting factor treatment, treating of carbohydrate moieties of the collagen containing material with capping molecules.
14. The method according to claim 8 wherein said cellular disruption treatment is selected from the group consisting of exposure to ultraviolet radiation, immersion in alcohol and/or freeze/thaw cycling.