IP Library Granted Patent US 10,758,575
Granted Patent B2
US 10,758,575 · App. 14/538,681 · Granted Sep 1, 2020

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

Inventors: María Gema Fernández Miguel (Tres Cantos-Madrid, ES); Manuel Ángel 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 AUTÓNOMA DE MADRID
A61K35/35A61B17/1659A61B17/32A61K45/06A61L24/0015A61L24/106A61L27/3604A61L27/3834A61L27/3839A61L27/3869A61L27/3895C12N5/0667A61B2017/320008A61K35/12A61L2300/64C12N2509/00C12N2510/00C12N2533/56
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Quick Facts
Patent No.
US 10,758,575
App. No.
14/538,681
Granted
Sep 1, 2020
Kind
B2
Abstract

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

Claims (25)

1. A method of treating a fistula in a subject, comprising delivering a composition comprising a population of cells comprising non-embryonic adipose tissue-derived stromal stem cells to the subject, wherein the non-embryonic adipose tissue-derived stromal stem cells are allogeneic to the subject, were not matched for MHC compatibility, less than 50% of the cells in the composition express the CD34 marker, and the subject does not receive an immunosuppressive agent to prevent rejection of the cells.

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

3. The method of claim 1 , wherein less than 5% of the cells in the composition express the CD31 marker.

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 non-embryonic adipose derived tissue-derived stromal stem 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 non-embryonic adipose tissue-derived stromal stem 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 said adhesive further comprises a composition comprising non-embryonic adipose tissue-derived stromal stem cells, wherein less than 5% of the cells in the composition express the CD31 marker.

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

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

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

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

13. 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.

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

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

16. The method of claim 14 , wherein said therapeutic agent is administered systemically to said subject.

17. The method of claim 14 , wherein said therapeutic agent is selected from the group consisting of an anti-inflammatory agent, a biological agent, an antibiotic and an antidiarrheal agent.

18. The method of claim 1 , wherein the non-embryonic adipose tissue-derived stromal stem cells are delivered irrespective of any MHC compatibility.

19. 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 non-embryonic adipose tissue-derived stromal stem cells to the closed sutured wound, wherein the non-embryonic adipose tissue-derived stromal stem cells are allogeneic to the subject, were not matched for MHC compatibility, less than 50% of the cells in the composition express the CD34 marker, and the subject does not receive an immunosuppressive agent to prevent rejection of the cells.

20. The method of claim 19 , wherein at least 50% of the cells in the composition express the CD44 marker.

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

22. 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 non-embryonic adipose tissue-derived stromal stem cells to the closed sutured internal hole, wherein the non-embryonic adipose tissue-derived stromal stem cells are allogeneic to the subject, were not matched for MHC compatibility, less than 50% of the cells in the composition express the CD34 marker, and the subject does not receive an immunosuppressive agent to prevent rejection of the cells.

Assignments (6)
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.L.
To: CELLERIX, S.A.
Reel/Frame 047141/0720 →
CONVERSION Recorded Jun 6, 2018
From: CELLERIX, S.A.
To: CELLERIX, S.A.U.
Reel/Frame 046314/0287 →
CHANGE OF NAME Recorded Feb 22, 2018
From: CELLERIX, S.A.U.
To: TIGENIX, S.A.U.
Reel/Frame 045417/0609 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Feb 20, 2018
From: FERNÁNDEZ MIGUEL, MARÍA GEMA; GONZÁLEZ DE LA PEÑA, MANUEL ÁNGEL; GARCÍA CASTRO, ROSA ANA
To: CELLERIX, S.L.
Reel/Frame 044976/0746 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Feb 15, 2018
From: GARCÍA ARRANZ, MARIANO; GARCÍA OLMO, DAMIÁN
To: UNIVERSIDAD AUTÓNOMA DE MADRID
Reel/Frame 044948/0615 →
Continuity (3)
Continuation 11993859
Continuation 11167061 · Jun 24, 2005
Related Publication 20150065948A1 · Mar 5, 2015