Cell-Scaffold Constructs

• US 20100131075A1
• Filed: 11/04/2009
• Published: 05/27/2010
• Est. Priority Date: 11/04/2008
• Status: Active Grant

• Current Assignee: Orgagen, Inc.
• Original Assignee: Tengion, Inc.
• Inventors: Quinlan, Sarah F., Genheimer, Christopher W., Basu, Joydeep, Payne, Richard, Jain, Deepak, Knight, Oluwatoyin A., Ilagan, Roger M., Rapoport, H. Scott, Bertram, Timothy A., Jayo, Manuel J., Ludlow, John W., Sangha, Namrata D., Guthrie, Kelly I.
• Granted Patent: US 8,337,485 B2
• Time in Patent Office: Days
• US Class Current: 623/23.660
• CPC Class Codes: A61F 2/042 Urinary bladders
• CPC Class Codes: A61L 2430/22 for reconstruction of hollow organs, e.g. bladder, esophagus, urether, uterus
• CPC Class Codes: A61L 27/18 obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
• 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 27/3826 Muscle cells, e.g. smooth muscle cells
• CPC Class Codes: A61L 27/3882 Hollow organs, e.g. bladder, esophagus, urether, uterus
• CPC Class Codes: C08L 67/04 Polyesters derived from hydroxycarboxylic acids, e.g. lactones C08L67/06 takes precedence

Abstract

The present invention relates to the regeneration, reconstruction, repair, augmentation or replacement of organs or tissue structures using scaffolds and autologous cells that are not derived from such organs or tissues.

Claims

1. A urinary diversion for a defective bladder in a subject comprising

a) a first implantable, biocompatible construct comprising a tubular scaffold having a first end configured to connect to an abdominal wall section, a second closed end, and at least a first side opening configured to connect to a first ureter;

and

b) an autologous cell population that is not derived from the defective bladder, deposited on or in a surface of the scaffold.

2. The urinary diversion of claim 1 wherein the scaffold further comprises a second side opening configured to connect to a second ureter.

3. The urinary diversion of claim 1 wherein the first end is configured to be positioned flush with the abdominal wall.

4. The urinary diversion of claim 3 wherein the first end is configured to be sutured to the skin of the subject.

5. The urinary diversion of claim 4 wherein the first end is configured to form a stoma.

6. The urinary diversion of claim 5 wherein the stoma further comprises a stoma button.

7. The urinary diversion of claim 5 or 6 wherein the scaffold further comprises a washer ring configured to form a stoma.

8. The urinary diversion of claim 1, wherein the biocompatible scaffold is biodegradable.

9. The urinary diversion of claim 1, wherein the scaffold comprises a material selected from the group consisting of polyglycolic acid, polylactic acid, and a copolymer of polyglycolic acid and polylactic acid.

10. The urinary diversion of claim 1, wherein the cell population is a smooth muscle cell population.

11. The urinary diversion of claim 1 wherein the diversion is a replacement for the defective bladder.

12. The urinary diversion of claim 1, wherein the diversion is temporary.

13. The urinary diversion of claim 1, wherein the diversion is permanent.

14. The urinary diversion of claim 1, wherein the tubular scaffold has a rectangular cross-section configuration.

15. The urinary diversion of claim 1, wherein the tubular scaffold has a triangular cross-section configuration.

16. The urinary diversion of claim 1, wherein the tubular scaffold has a circular cross-section configuration.

17. The urinary diversion of claim 1, wherein the diversion is free of urothelial cells.

18. A method of preparing a urinary diversion construct for a defective bladder in a subject in need comprising

a) providing a first implantable biocompatible scaffold comprising a tubular scaffold having a first end configured to contact an abdominal wall section, a second closed end, and at least a first side opening configured to connect to a first ureter;

and

b) depositing an autologous cell population that is not derived from the defective bladder on or in a first area of said scaffold to form a urinary diversion construct.

19. The method of claim 18, wherein the scaffold further comprises a second side opening configured to connect to a second ureter.

20. The method of claim 18, wherein the first end is configured to be positioned flush with the abdominal wall.

21. The method of claim 20, wherein the first end is configured to be sutured to the skin of the subject.

22. The method of claim 21 wherein the first end is configured to form a stoma.

23. The method of claim 22, wherein the stoma further comprises a stoma button.

24. The method of claim 22 or 23, wherein the scaffold further comprises a washer ring configured to form a stoma.

25. The method of claim 18, wherein the biocompatible scaffold is biodegradable.

26. The method of claim 18, wherein the scaffold comprises a material selected from the group consisting of polyglycolic acid, polylactic acid, and a copolymer of polyglycolic acid and polylactic acid.

27. The method of claim 18, wherein the cell population is a smooth muscle cell population.

28. The method of claim 18, wherein the diversion is a replacement for the defective bladder.

29. The method of claim 18, wherein the diversion is temporary.

30. The method of claim 18, wherein the diversion is permanent.

31. The method of claim 18, wherein the tubular scaffold has a rectangular cross-section configuration.

32. The method of claim 18, wherein the tubular scaffold has a triangular cross-section configuration.

33. The method of claim 18, wherein the tubular scaffold has a circular cross-section configuration.

34. The method of claim 18, wherein the diversion is free of urothelial cells.

35. A method of providing a urinary diversion for a defective bladder in a subject in need comprising

a) providing a first implantable biocompatible scaffold comprising a tubular scaffold having a first end configured to connect to an abdominal wall section, a second closed end, and at least a first side opening configured to connect to a first ureter;

and

b) depositing an autologous cell population that is not derived from the defective bladder on or in a first area of said scaffold to form a urinary diversion construct; and

c) implanting the construct into said subject for the formation of the urinary diversion.

37. The method of claim 35 or 36 wherein the scaffold further comprises a second side opening configured to connect to a second ureter.

38. The method of claim 35 or 36 wherein the first end is configured to be positioned flush with the abdominal wall.

39. The method of claim 35 or 36 wherein the first end is configured to be sutured to the skin of the subject.

40. The method of claim 39 wherein the first end is configured to form a stoma.

41. The method of claim 40 wherein the stoma further comprises a stoma button.

42. The method of claim 40 or 41 wherein the scaffold further comprises a washer ring configured to form a stoma.

43. The method of claim 35 or 36, wherein the biocompatible scaffold is biodegradable.

44. The method of claim 35 or 36, wherein the scaffold comprises a material selected from the group consisting of polyglycolic acid, polylactic acid, and a copolymer of polyglycolic acid and polylactic acid.

45. The method of claim 35 or 36, wherein the cell population is a smooth muscle cell population.

46. The method of claim 35 or 36 wherein the diversion is a replacement for the defective bladder.

47. The method of claim 35 or 36, wherein the diversion is temporary.

48. The method of claim 35 or 36, wherein the diversion is permanent.

49. The method of claim 35 or 36, wherein the tubular scaffold has a rectangular cross-section configuration.

50. The method of claim 35 or 36, wherein the tubular scaffold has a triangular cross-section configuration.

51. The method of claim 35 or 36, wherein the tubular scaffold has a circular cross-section configuration.

52. The method of claim 35 or 36, wherein the diversion is free of urothelial cells.

53. The method of claim 35 or 36, wherein the urinary conduit construct forms regenerated tissue upon implantation.

54. The method of claim 53, wherein the regenerated tissue comprises continuous urothelium with underlying smooth muscle.

55. The method of claim 35 or 36, wherein the urinary conduit construct forms an epithelialized mucosa upon implantation.

36. A method of providing a urinary diversion for a defective bladder in a subject in need comprising implanting into said subject a urinary diversion construct comprising (a) a tubular scaffold having a first end configured to contact an abdominal wall section, a second closed end, and at least a first side opening configured to connect to a first ureter;

and (b) an autologous cell population that is not derived from the defective bladder, deposited on or in a surface of the scaffold, for the formation of the urinary diversion.