IP Library Granted Patent US 10,092,603
Granted Patent B2
US 10,092,603 · App. 15/730,203 · Granted Oct 9, 2018

Composition for inducing proliferation or accumulation of regulatory T cells

Inventors: Kenya Honda (Tokyo, JP); Koji Atarashi (Tokyo, JP); Kikuji Itoh (Tokyo, JP); Takeshi Tanoue (Tokyo, JP)
Assignee: The University of Tokyo
A61K35/742A01K67/0275A61K9/0053A61K9/48A61K35/74A61K39/0008A61K39/08A61K39/39A61K45/00A61K45/06C12Q1/689G01N33/505A01K2267/0325A61K35/00A61K2039/52A61K2039/542A61K2039/55594A61K2039/57C12Q2600/158G01N2333/33G01N2500/10
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Quick Facts
Patent No.
US 10,092,603
App. No.
15/730,203
Granted
Oct 9, 2018
Kind
B2
Abstract

It was found that bacteria belonging to the genus Clostridium induce accumulation of regulatory T cells (Treg cells) in the colon. Moreover, the present inventors found that regulatory T cells (Treg cells) induced by from these bacteria suppressed proliferation of effector T-cells. From these findings, the present inventors found that the use of bacteria belonging to the genus Clostridium or a physiologically active substance derived therefrom made it possible to induce proliferation or accumulation of regulatory T cells (Treg cells), and further to suppress immune functions.

Claims (51)

1. A method of treating a human subject having an infectious disease, an autoimmune disease or an allergic disease, the method comprising

administering a pharmaceutical composition comprising a purified bacterial mixture of at least four live bacterial strains belonging to Clostridium clusters IV and/or XIVa to the human subject,

wherein the bacterial strains are spore-forming bacteria and are isolated from a human.

2. The method of claim 1 , wherein the pharmaceutical composition comprises five or more bacterial strains.

3. The method of claim 1 , wherein the pharmaceutical composition comprises six or more bacterial strains.

4. The method of claim 1 , wherein the pharmaceutical composition comprises seven or more bacterial strains.

5. The method of claim 1 , wherein the pharmaceutical composition comprises eight or more bacterial strains.

6. The method of claim 1 , wherein the pharmaceutical composition comprises nine or more bacterial strains.

7. The method of claim 1 , wherein the pharmaceutical composition comprises ten or more bacterial strains.

8. The method of claim 1 , wherein the pharmaceutical composition comprises eleven or more bacterial strains.

9. The method of claim 1 , wherein the pharmaceutical composition comprises twelve or more bacterial strains.

10. The method of claim 1 , wherein the pharmaceutical composition comprises thirteen or more bacterial strains.

11. The method of claim 1 , wherein the pharmaceutical composition comprises fourteen or more bacterial strains.

12. The method of claim 1 , wherein the pharmaceutical composition comprises fifteen or more bacterial strains.

13. The method of claim 1 , wherein the human has an autoimmune disease.

14. The method of claim 13 , wherein the autoimmune disease is organ transplant rejection, inflammatory bowel disease (IBD), ulcerative colitis, Crohn's disease, sprue, rheumatoid arthritis, Type I diabetes, graft versus host disease, or multiple sclerosis.

15. The method of claim 13 , wherein the autoimmune disease is inflammatory bowel disease (IBD).

16. The method of claim 13 , wherein the autoimmune disease is ulcerative colitis.

17. The method of claim 13 , wherein the autoimmune disease is Crohn's disease.

18. The method of claim 1 , wherein the human has an allergic disease.

19. The method of claim 1 , wherein the human has an infectious disease.

20. The method of claim 19 , wherein the infectious disease is Clostridium difficile infection.

21. The method of claim 1 , wherein the pharmaceutical composition is formulated for delivery to the intestine.

22. The method of claim 1 , wherein the pharmaceutical composition is formulated for oral administration.

23. The method of claim 1 , wherein the pharmaceutical composition comprises a pH sensitive composition comprising one or more enteric polymers.

24. The method of claim 1 , wherein the pharmaceutical composition is in the form of a capsule.

25. The method of claim 1 , wherein the bacteria are in the form of spores.

26. A method of treating a human subject having an allergic disease, the method comprising

administering a pharmaceutical composition comprising a purified bacterial mixture of at least two live bacterial strains belonging to Clostridium clusters IV and/or XIVa to the human subject,

wherein the bacterial strains are isolated from a human, and wherein the composition does not include Bacteroides.

27. The method of claim 26 , wherein the pharmaceutical composition is formulated for delivery to the intestine.

28. The method of claim 26 , wherein the pharmaceutical composition is formulated for oral administration.

29. The method of claim 26 , wherein the pharmaceutical composition comprises a pH sensitive composition comprising one or more enteric polymers.

30. The method of claim 26 , wherein the pharmaceutical composition is in the form of a capsule.

31. The method of claim 26 , wherein the bacteria are in the form of spores.

32. A method of treating a human subject having an allergic disease, the method comprising

administering a pharmaceutical composition comprising a purified bacterial mixture of at least two live bacterial strains belonging to Clostridium clusters IV and/or XIVa to the human subject,

wherein the bacterial strains are isolated from a human, and wherein the composition does not include Lactobacillus.

33. The method of claim 32 , wherein the pharmaceutical composition is formulated for delivery to the intestine.

34. The method of claim 32 , wherein the pharmaceutical composition is formulated for oral administration.

35. The method of claim 32 , wherein the pharmaceutical composition comprises a pH sensitive composition comprising one or more enteric polymers.

36. The method of claim 32 , wherein the pharmaceutical composition is in the form of a capsule.

37. The method of claim 32 , wherein the bacteria are in the form of spores.

38. A method of treating a human subject having an allergic disease, the method comprising

administering a pharmaceutical composition comprising a purified bacterial mixture of at least two live bacterial strains belonging to Clostridium clusters IV and/or XIVa to the human subject,

wherein the bacterial strains are isolated from a human, and wherein the composition does not include Bifidobacterium.

39. The method of claim 38 , wherein the pharmaceutical composition is formulated for delivery to the intestine.

40. The method of claim 38 , wherein the pharmaceutical composition is formulated for oral administration.

41. The method of claim 38 , wherein the pharmaceutical composition comprises a pH sensitive composition comprising one or more enteric polymers.

42. The method of claim 38 , wherein the pharmaceutical composition is in the form of a capsule.

43. The method of claim 38 , wherein the bacteria are in the form of spores.

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jun 20, 2018
From: HONDA, KENYA; ATARASHI, KOJI; ITOH, KIKUJI; TANOUE, TAKESHI
To: THE UNIVERSITY OF TOKYO
Reel/Frame 046142/0783 →
Priority Claims (2)
JP 2010-129134 · Jun 4, 2010 · national
WO PCT/JP2010/071746 · Dec 3, 2010 · international
Continuity (4)
Continuation 15216015 · Jul 21, 2016
Continuation 14492850 · Sep 22, 2014
Continuation 13701467
Related Publication 20180153981A1 · Jun 7, 2018
Cited By (3)
US 12,214,003 US 12,409,196 US 12,502,411