IP Library Granted Patent US 8,999,709
Granted Patent B2
US 8,999,709 · App. 11/993,859 · Granted Apr 7, 2015

Use of adipose tissue-derived stromal stem cells in treating fistula

Inventors: María Gema Fernández Miguel (Tres Cantos-Madrid, ES); Manuel Angel González de la Peña (Tres Cantos-Madrid, ES); Rosa Ana García Castro (Tres Cantos-Madrid, ES); Mariano García Arranz (Cantoblanco-Madrid, ES); Damián García Olmo (Cantoblanco-Madrid, ES)
Assignees: Tigenix, S.A.U.; Universidad Autonoma de Madrid
A61K35/35C12N2533/56A61K35/12A61L27/3839C12N5/0667A61L27/3895A61L24/106A61L27/3834A61L27/3604
View Patent ↗
Loading inventors, assignments & file history…
Monitor This Case
Get email alerts when status or documents change.
Order Certified Copies
Most orders are placed with the USPTO same day — all within 24 business hours.
Order via The Patent Place →
Pre-filled with this patent's details
Quick Facts
Patent No.
US 8,999,709
App. No.
11/993,859
Granted
Apr 7, 2015
Kind
B2
Abstract

Provided herein are novel methods and compositions utilizing adipose tissue-derived stromal stem cells for treating fistulae.

Claims (49)

1. A method of treating a fistula in a subject, comprising delivering a population of cells comprising adipose tissue-derived stromal cells to the subject, wherein less than 5% of the cells in the population express the CD34 marker.

2. The method of claim 1 , wherein the population comprises at least 10×10 6 adipose tissue-derived stromal cells.

3. The method of claim 1 , wherein the adipose tissue-derived stromal cells are allogeneic to the subject.

4. The method of claim 1 , wherein at least 50% of the cells in the population express the CD44 marker.

5. The method of claim 1 further comprising deep scraping of the fistula prior to delivering the adipose derived tissue-derived stromal cells and filling said fistula with an adhesive before, during or after delivering the population of cells.

6. The method of claim 5 , wherein the population comprises at least 10×10 6 adipose tissue-derived stromal cells that are mixed with the adhesive before delivering the population of cells.

7. The method of claim 5 , wherein said adhesive is a fibrin glue or gel.

8. The method of claim 5 , wherein at least 50% of the cells in the composition express the CD44 marker.

9. The method of claim 1 , wherein said method further comprises: delivering a second dose of at least 20×10 6 adipose tissue-derived stromal cells.

10. The method of claim 1 , wherein the population comprises at least 20×10 6 adipose tissue-derived stromal cells.

11. The method of claim 10 , wherein said method further comprises: delivering a second dose of at least 40×10 6 adipose tissue-derived stromal cells.

12. The method of claim 1 , wherein the fistula is selected from the group consisting of an anorectal fistula, enteroenteral fistula, enterocutaneous fistula, rectovaginal fistula, vesicovaginal fistula, fistula-in-ano, fecal fistula, arteriovenous fistula, biliary fistula, cervical fistula, craniosinus fistula, enterovaginal, gastric fistula, metroperitoneal fistula perilymph, pulmonary arteriovenous fistula, umbilical fistula, and tracheoesophageal fistula.

13. The method of claim 1 , further comprising administering a therapeutic agent to said subject.

14. The method of claim 13 , wherein said therapeutic agent is administered locally to the fistula.

15. The method of claim 13 , wherein said therapeutic agent is administered systemically to said subject.

16. The method of claim 13 , wherein said therapeutic agent is selected from the group consisting of an anti-inflammatory agent, an immunosuppressive agent, a biological agent, an antibiotic and an antidiarrheal agent.

17. A method of treating a wound in a subject, comprising: (a) closing the wound with a suture and (b) delivering a composition comprising at least 10×10 6 adipose tissue-derived stromal cells to the closed sutured wound, wherein the adipose tissue-derived stromal cells have been passaged at least six times, and wherein less than 5% of the cells in the composition express the CD34 marker.

18. The method of claim 17 , wherein at least 50% of the cells in the composition express the CD44 marker.

19. The method according to claim 17 , wherein the wound is a fistula selected from the group consisting of anorectal fistula, enterorectal fistula, enterocutaneous fistula, rectovaginal fistula and vesicovaginal fistula.

20. A method of treating a fistula in a subject comprising the steps of:

(i) deep scraping of at least one fistula track

(ii) closing the internal hole of the scraped track with a suture

(iii) delivering a composition comprising at least 10×10 6 adipose tissue-derived stromal cells to the closed sutured internal hole, wherein less than 5% of the cells in the composition express the CD34 marker.

21. A method of treating a fistula in a subject, comprising delivering a population of cells comprising adipose tissue-derived stromal cells to the subject, wherein the adipose tissue-derived stromal cells are allogeneic to the subject, and wherein less than 5% of the cells in the population express the CD34 marker.

22. The method of claim 21 , wherein the population comprises at least 10×10 6 adipose tissue-derived stromal cells.

23. The method of claim 21 , wherein the adipose tissue-derived stromal cells have been passaged at least six times.

24. The method of claim 21 , wherein less than 5% of the cells in the population express the CD34 marker.

25. The method of claim 24 , wherein at least 50% of the cells in the population express the CD44 marker.

26. The method of claim 21 further comprising deep scraping of the fistula prior to delivering the adipose derived tissue-derived stromal cells and filling said fistula with an adhesive before, during or after delivering the population of cells.

27. The method of claim 26 , wherein the population comprises at least 10×10 6 adipose tissue-derived stromal cells that are mixed with the adhesive before delivering the population of cells.

28. The method of claim 26 , wherein said adhesive is a fibrin glue or gel.

29. The method of claim 26 , wherein said adhesive further comprises a composition comprising adipose tissue-derived stromal cells, wherein less than 5% of the cells in the composition express the CD34 marker.

30. The method of claim 29 , wherein at least 50% of the cells in the composition express the CD44 marker.

31. The method of claim 21 , wherein said method further comprises: delivering a second dose of at least 20×10 6 adipose tissue-derived stromal cells.

32. The method of claim 21 , wherein the population comprises at least 20×10 6 adipose tissue-derived stromal cells.

33. The method of claim 32 , wherein said method further comprises: delivering a second dose of at least 40×10 6 adipose tissue-derived stromal cells.

34. The method of claim 21 , wherein the fistula is selected from the group consisting of an anorectal fistula, enteroenteral fistula, enterocutaneous fistula, rectovaginal fistula, vesicovaginal fistula, fistula-in-ano, fecal fistula, arteriovenous fistula, biliary fistula, cervical fistula, craniosinus fistula, enterovaginal, gastric fistula, metroperitoneal fistula perilymph, pulmonary arteriovenous fistula, umbilical fistula, and tracheoesophageal fistula.

35. The method of claim 21 , further comprising administering a therapeutic agent to said subject.

36. The method of claim 35 , wherein said therapeutic agent is administered locally to the fistula.

37. The method of claim 35 , wherein said therapeutic agent is administered systemically to said subject.

38. The method of claim 35 , wherein said therapeutic agent is selected from the group consisting of an anti-inflammatory agent, an immunosuppressive agent, a biological agent, an antibiotic and an antidiarrheal agent.

39. A method of treating a wound in a subject, comprising: (a) closing the wound with a suture and (b) delivering a composition comprising at least 10×10 6 adipose tissue-derived stromal cells to the closed sutured wound, wherein the adipose tissue-derived stromal cells are allogeneic to the subject, and wherein less than 5% of the cells in the population express the CD34 marker.

40. The method of claim 39 , wherein less than 5% of the cells in the composition express the CD34 marker.

41. The method of claim 40 , wherein at least 50% of the cells in the composition express the CD44 marker.

42. The method according to claim 39 , wherein the wound is a fistula selected from the group consisting of anorectal fistula, enterorectal fistula, enterocutaneous fistula, rectovaginal fistula and vesicovaginal fistula.

43. A method of treating a fistula in a subject comprising the steps of:

(i) deep scraping of at least one fistula track

(ii) closing the internal hole of the scraped track with a suture

(iii) delivering composition comprising at least 10×10 6 adipose tissue-derived stromal cells to the closed sutured internal hole, wherein the adipose tissue-derived stromal cells are allogeneic to the subject, and wherein less than 5% of the cells in the population express the CD34 marker.

Assignments (7)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jun 15, 2022
From: TIGENIX, S.A.U.
To: TAKEDA PHARMACEUTICAL COMPANY LIMITED
Reel/Frame 060516/0532 →
CONVERSION Recorded Jun 6, 2018
From: CELLERIX, S.A.
To: CELLERIX, S.A.U.
Reel/Frame 046314/0287 →
CONVERSION Recorded Jun 6, 2018
From: CELLERIX, S.L.
To: CELLERIX, S.A.
Reel/Frame 047141/0720 →
CHANGE OF NAME Recorded Feb 22, 2018
From: CELLERIX, S.A.U.
To: TIGENIX, S.A.U.
Reel/Frame 045417/0609 →
CHANGE OF NAME Recorded Feb 15, 2013
From: CELLERIX, S.A.
To: TIGENIX, S.A.U.
Reel/Frame 029822/0564 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Dec 22, 2009
From: GARCIA ARRANZ, MARIANO; GARCIA OLMO, DAMIAN
To: UNIVERSIDAD AUTONOMA DE MADRID
Reel/Frame 023686/0532 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Dec 22, 2009
From: FERNANDEZ MIGUEL, MARIA GEMA; GONZALEZ DE LA PENA, MANUEL ANGEL; GARCIA CASTRO, ROSA ANA
To: CELLERIX, S.L.
Reel/Frame 023685/0905 →
Continuity (2)
Continuation 11167061 · Jun 24, 2005
Related Publication 20100098669A1 · Apr 22, 2010