Extracellular matrix composite materials, and manufacture and use thereof

• US 20060147433A1
• Filed: 03/03/2006
• Published: 07/06/2006
• Est. Priority Date: 09/04/2003
• Status: Active Grant

• Current Assignee: Cook Biotech Incorporated (Cook Group Incorporated)
• Original Assignee: Cook Biotech Incorporated (Cook Group Incorporated)
• Inventors: Hiles, Michael C.
• Granted Patent: US 7,795,027 B2
• Time in Patent Office: Days
• US Class Current: 424/93.700
• CPC Class Codes: A61K 35/22 Urine; Urinary tract, e.g. kidney or bladder; Intraglomerular mesangial cells; Renal mesenchymal cells; Adrenal gland
• CPC Class Codes: A61K 35/37 Digestive system
• CPC Class Codes: A61K 35/44 Vessels; Vascular smooth muscle cells; Endothelial cells; Endothelial progenitor cells
• CPC Class Codes: A61L 27/3629 Intestinal tissue, e.g. small intestinal submucosa
• CPC Class Codes: A61L 27/3633 Extracellular matrix [ECM]
• 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 27/3645 Connective tissue
• CPC Class Codes: A61L 27/3804 characterised by specific cells or progenitors thereof, e.g. fibroblasts, connective tissue cells, kidney cells
• CPC Class Codes: A61L 27/48 with macromolecular fillers
• CPC Class Codes: C08L 89/00 Compositions of proteins; Compositions of derivatives thereof foodstuff preparations A23J3/00

Abstract

Described are preferred extracellular matrix composites including a first extracellular matrix material having a second extracellular matrix material deposited thereon. The preferred materials are made by culturing cells in contact with an extracellular matrix graft material in a fashion to cause the cells to biosynthesize and deposit extracellular matrix components on the material. The cells are then removed to provide the extracellular matrix composite material.

Claims

1. A medical graft material, comprising an acellular extracellular matrix composite including a first extracellular matrix material having a surface, and a second, biosynthetically-deposited extracellular matrix material on said surface.

2. The medical graft material of claim 1, wherein said second extracellular matrix material comprises one or more fiber-forming proteins.

3. The medical graft material of claim 2, wherein the one or more fiber-forming proteins include collagen end/or elastin.

4. The medical graft material of claim 1, wherein said second extracellular matrix material comprises one or more adhesive proteins.

5. The medical graft material of claim 4, wherein said adhesive proteins comprise fibronectin and/or laminin.

6. The medical graft material of claim 1, wherein the first extracellular matrix material comprises submucosa.

7. The medical graft material of claim 6, wherein the submucosa is intestinal, urinary bladder or stomach submucosa.

8. The medical graft material of claim 7, wherein the submucosa is small intestinal submucosa.

9. The medical graft material of claim 1, wherein the first extracellular matrix material is from a warm-blooded vertebrate.

10. The medical graft material of claims 1, wherein the second extracellular matrix material is human.

11. The medical graft material of claim 1, wherein the second extracellular matrix material is secreted by one or more of endothelial cells, muscle cells, fibroblast cells, mesothelial cells, pericyte cells, macrophage cells, monocyte cells, plasma cells, mast cells, adipocyte cells, chondrocyte cells, stem cells, or a cell population differentiated from stem cells.

12. The medical graft material of claim 11, wherein the second extracellular matrix material contains matrix components secreted by endothelial cells.

13. The medical graft material of claim 12, wherein the endothelial cells are vascular endothelial cells.

14. The medical graft material of claim 13 which is configured for implantation in the cardiovascular system of a human.

15. The medical graft material of claim 14, which has a tubular form, and wherein at least a lumenal surface of the tubular form contains said second extracellular matrix material.

16. The medical graft material of any of claims 14, wherein said extracellular matrix composite is substantially devoid of cells or cell components.

30. The method of claim 1, wherein said isolating comprises rendering the extracellular matrix composite substantially devoid of cells and cell components.

45. A method for treating a patient, comprising contacting tissue of the patient with a medical graft material according to claim 1.

46. The method of claim 45, wherein:

the first extracellular matrix material is non-human; and

the second extracellular matrix material is human.

47. The method of claim 45, which is a method for treating skin tissue of the patient, and wherein the second extracellular matrix material is deposited by fibroblasts and/or keratinocytes.

48. The method of claim 45, which is a method for treating corneal tissue of the patient, and wherein the second extracellular matrix material is deposited by corneal endothelial and/or epithelial cells.

49. The method of claim 45, which is a method for treating cartilage tissue of the patient, and wherein the second extracellular matrix material is deposited by chondrocyte cells.

17. A method for preparing an acellular extracellular matrix composite, comprising:

providing a first extracellular matrix material having a surface;

culturing cells in vitro under conditions to secrete a second extracellular matrix material wherein said second material is transferred to said surface to form an #389010 extracellular matrix composite comprising said first extracellular matrix material with said second extracellular matrix material on said surface; and

isolating the extracellular matrix composite in acellular form.

18. The method of claim 17, wherein said second extracellular matrix material comprises one or more fiber-forming proteins.

19. The method of claim 18, wherein the one or more fiber-forming proteins include collagen and/or elastin.

22. The method of claim 17, wherein the first extracellular matrix material comprises submucosa.

23. The method of claim 22, wherein the submucosa is intestinal, urinary bladder or stomach submucosa.

24. The method of claim 23, wherein the submucosa is small intestinal submucosa.

25. The method of claim 17, wherein the first extracellular matrix material is porcine.

26. The method of claims 17, wherein the second extracellular matrix material is human.

27. The method of claims 17, wherein the second extracellular matrix material is secreted by one or more of endothelial cells, muscle cells, fibroblast cells, mesothelial cells, pericyte cells, macrophage cells, monocyte cells, plasma cells, mast cells, adipocyte cells, chondrocyte cells, stem cells, or a cell population differentiated from stem cells.

28. The method of claim 27, wherein the second extracellular matrix material contains matrix components secreted by endothelial cells.

29. The method of claim 28, wherein the endothelial cells are vascular endothelial cells.

20. The method of any of claims 1749, wherein said second extracellular matrix material comprises one or more adhesive proteins.

21. The method of claim 20, wherein said adhesive proteins comprise fibronectin and/or laminin.

31. An extracellular matrix graft prosthesis conditioned with matrix components, comprising:

a bioremodelable extracellular matrix graft material essentially free of cells and cell components; and

biosynthetically-deposited exogenous extracellular matrix components on said bioremodelable extracellular matrix graft material.

32. A graft prosthesis of claim 31, wherein said extracellular matrix comprises a submucosa, dura mater, pericardium, serosa, peritoneum, or basement membrane matrix material.

33. A graft prosthesis of claim 32, wherein said extracellular matrix comprises submucosa.

34. A graft prosthesis of claim 33, wherein said submucosa is mammalian submucosa.

35. A graft prosthesis of claim 34, wherein said mammalian submucosa is porcine, bovine, or ovine submucosa.

36. A graft prosthesis of claim 35, wherein said submucosa is porcine submucosa.

37. A graft prosthesis according to claim 31, wherein said matrix components include one or more members selected from the group consisting of collagen, elastin, fibronectin, and laminin.

38. A graft prosthesis according to claim 31, wherein said prosthesis has a tubular form, and said matrix components are on at least a lumenal surface of said tubular form.

39. A graft prosthesis according to claim 31, wherein said prosthesis has a sheet form, and wherein said matrix components are deposited on a surface of at least a first side of said sheet form.

40. A graft prosthesis according to claim 31, wherein said prosthesis has multiple layers, including at least one layer of said a bioremodelable extracellular matrix graft material.

41. A graft prosthesis according to claim 40, wherein said prosthesis has multiple layers of said bioremodelable extracellular matrix graft material.

42. A graft prosthesis according to claim 31, essentially free of cells and cell components.

43. A graft prosthesis according to claim 31, wherein said matrix components are human.

44. A method of making a conditioned extracellular matrix graft prosthesis, comprising:

providing a first extracellular matrix material;

culturing cells in contact with said extracellular matrix material;

causing said cells to synthesize and deposit a second extracellular matrix material upon said first extracellular matrix material; and

removing said cells to form an extracellular matrix graft prosthesis containing said first and second extracellular matrix materials and essentially free of said cells and membranes thereof.