Tissue products derived from animals lacking any expression of functional alpha 1,3 galactosyltransferase

• US 20050260176A1
• Filed: 03/17/2005
• Published: 11/24/2005
• Est. Priority Date: 08/21/2002
• Status: Active Grant

• Current Assignee: Revivicor, Inc (United Therapeutics Corporation)
• Original Assignee: Revivicor, Inc (United Therapeutics Corporation)
• Inventors: Rohricht, Paul, Ayares, David
• Granted Patent: US 8,106,251 B2
• Time in Patent Office: Days
• US Class Current: 424/93.700
• CPC Class Codes: A01K 2217/075 inducing loss of function, i.e. knock out
• CPC Class Codes: A01K 2227/108 Swine
• CPC Class Codes: A01K 2267/02 Animal zootechnically ameliorated
• CPC Class Codes: A01K 2267/025 Animal producing cells or organs for transplantation
• CPC Class Codes: A01K 67/0276 Knock-out vertebrates
• CPC Class Codes: A61K 35/12 Materials from mammals; Compositions comprising non-specified tissues or cells; Compositions comprising non-embryonic stem cells; Genetically modified cells vaccines or medicinal preparations containing antigens or antibodies A61K39/00
• CPC Class Codes: A61L 2430/34 for soft tissue reconstruction
• CPC Class Codes: A61L 27/3604 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
• CPC Class Codes: A61L 27/3629 Intestinal tissue, e.g. small intestinal submucosa
• CPC Class Codes: A61L 27/3641 characterised by the site of application in the body materials for artificial blood vessels A61L27/507; materials for use in artificial skin A61L27/60
• CPC Class Codes: A61L 27/3683 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
• CPC Class Codes: A61L 27/3695 characterised by the function or physical properties of the final product, where no specific conditions are defined to achieve this A61L27/3687, A61L27/3691 take precedence
• CPC Class Codes: A61P 17/00 Drugs for dermatological disorders
• CPC Class Codes: A61P 19/02 for joint disorders, e.g. arthritis, arthrosis
• CPC Class Codes: A61P 19/08 for bone diseases, e.g. rachitism, Paget's disease
• CPC Class Codes: C12N 15/8509 for producing genetically modified animals, e.g. transgenic
• CPC Class Codes: C12N 9/1051 Hexosyltransferases (2.4.1)

Abstract

The present invention provides tissues derived from animals, which lack any expression of functional alpha 1,3 galactosyltransferase (alpha-1,3-GT). Such tissues can be used in the field of xenotransplantation, such as orthopedic reconstruction and repair, skin repair and internal tissue repair or as medical devices.

Claims

1. A prosthesis comprising a tissue product derived from an animal lacking any expression of alpha-1,3-galactosyltransferase.

2. The prosthesis of claim 1, wherein the tissue is a hard tissue.

3. The prosthesis of claim 1, wherein the tissue is a soft tissue.

4. The animal of claim 1, wherein the animal is an ungulate.

5. The animal of claim 4, wherein the ungulate is a porcine animal.

6. The prosthesis of claim 2, wherein the hard tissue is bone or a fragment or derivative thereof.

7. The prosthesis of claim 3, wherein the soft tissue is selected from the group consisting of skin, dermal, submucosal, ligament, tendon and cartilage or a fragment or derivative thereof.

8. The prosthesis of claim 1, wherein the tissue is a combination of hard and soft tissue.

9. The tissue of claim 8, wherein the tissue is a bone-tendon-bone graft.

11. The tissue of claim 9, wherein the animal is an ungulate.

13. The de-cellularized tissue of claim 9, wherein the tissue is soft tissue.

14. The tissue of claim 9, wherein the soft tissue is dermal tissue.

15. The tissue of claim 9, wherein the soft tissue is submucosal tissue.

16. The tissue of claim 11, wherein the submucosal tissue derived from the small intestine.

17. The use of the tissue of claim 9 as a scaffold.

10. A de-cellularized tissue product derived from an animal lacking any expression of alpha-1,3-galactosyltransferase.

12. The tissue of claim 10, wherein the animal is a porcine animal.

18. A method to reconstruct or repair a human body part comprising a tissue product derived from an animal lacking any expression of alpha-1,3-galactosyltransferase.

19. The method of claim 18, wherein the animal is an ungulate.

20. The method of claim 18, wherein the animal is a porcine animal.

21. The method of claim 18, wherein the tissue is used for human orthopedic reconstruction or repair.

22. The method of claim 21, wherein the tissue is used for rotator cuff repair.

23. The method of claim 21, wherein the tissue for the repair or reconstruction is selected from the group consisting of bone, tendon, ligament and cartilage.

24. The method of claim 21, wherein the tissue is a bone-tendon-bone graft.

25. The method of claim 18, wherein the tissue is used for human skin repair.

26. The method of claim 18, wherein the tissue is used for human soft tissue repair.

27. The method of claim 18, wherein the tissue is de-cellularized.

28. The method of claim 27, wherein the de-cellularized tissue is used a scaffold to reconstruct or repair a human body part.