Treatment of inflammatory diseases using placental stem cells

• US 8,460,650 B2
• Filed: 02/12/2008
• Issued: 06/11/2013
• Est. Priority Date: 02/12/2007
• Status: Active Grant

• Current Assignee: Celularity, Inc.
• Original Assignee: Anthrogenesis Corporation (Bristol-Myers Squibb Company)
• Inventors: Edinger, James W., Hariri, Robert J., Wang, Jia-Lun, Ye, Qian, Faleck, Herbert
• Primary Examiner(s): Schultz, Doug
• Application Number:
  US12/030,161
• Publication Number:
  US 20080226595A1
• Time in Patent Office: 1,946 Days
• Field of Search: None
• US Class Current: 424/93.7
• CPC Class Codes: A61K 2035/122 for inducing tolerance or supression of immune responses
• CPC Class Codes: A61K 2300/00 Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
• CPC Class Codes: A61K 35/50 Placenta; Placental stem cells; Amniotic fluid; Amnion; Amniotic stem cells
• CPC Class Codes: A61K 35/644 Beeswax; Propolis; Royal jelly; Honey
• CPC Class Codes: A61K 38/21 Interferons [IFN]
• CPC Class Codes: A61K 45/06 Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
• CPC Class Codes: A61P 1/12 Antidiarrhoeals
• CPC Class Codes: A61P 17/00 Drugs for dermatological disorders
• CPC Class Codes: A61P 19/02 for joint disorders, e.g. arthritis, arthrosis
• CPC Class Codes: A61P 25/00 Drugs for disorders of the nervous system
• CPC Class Codes: A61P 25/02 for peripheral neuropathies
• CPC Class Codes: A61P 29/00 Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
• CPC Class Codes: A61P 3/10 for hyperglycaemia, e.g. antidiabetics
• CPC Class Codes: A61P 35/02 specific for leukemia
• CPC Class Codes: A61P 37/00 Drugs for immunological or allergic disorders
• CPC Class Codes: A61P 37/02 Immunomodulators
• CPC Class Codes: A61P 37/06 Immunosuppressants, e.g. drugs for graft rejection
• CPC Class Codes: A61P 9/14 Vasoprotectives; Antihaemorrhoidals; Drugs for varicose therapy; Capillary stabilisers
• CPC Class Codes: C12N 2500/25 Insulin-transferrin; Insulin-transferrin-selenium
• CPC Class Codes: C12N 2500/36 Lipids
• CPC Class Codes: C12N 2501/11 : Epidermal growth factor [EGF]
• CPC Class Codes: C12N 2501/135 : Platelet-derived growth factor [PDGF]
• CPC Class Codes: C12N 2501/39 : Steroid hormones
• CPC Class Codes: C12N 5/0605 : Cells from extra-embryonic tissues, e.g. placenta, amnion, yolk sac, Wharton's jelly

Abstract

Provided herein are methods of treatment of individuals having an immune-related disease, disorder or condition, for example, inflammatory bowel disease, graft-versus-host disease, multiple sclerosis, rheumatoid arthritis, psoriasis, lupus erythematosus, diabetes, mycosis fungoides (Alibert-Bazin syndrome), or scleroderma using placental stem cells or umbilical cord stem cells.

Claims

1. A method of treating an individual having or at risk of developing inflammatory bowel disease, comprising administering to the individual a therapeutically effective amount of non-hematopoietic placental stem cells, wherein said placental stem cells are CD10⁺, CD34⁻

, CD105⁺, CD200⁺, and CD117⁻

as detectable by flow cytometry, wherein the therapeutically effective amount is an amount sufficient to cause a detectable improvement in one or more symptoms of said inflammatory bowel disease, and wherein said administering is by intravenous, subcutaneous, or parenteral administration.

10. The method of claim 1, wherein said administration of placental stem cells comprises intravenous administration.

12. The method of claim 1, wherein 1×

10⁸ to 5×

10⁸ placental stem cells are administered.

14. The method of claim 1, wherein between 1 million and 10 billion placental stem cells are administered.

16. The method of claim 1, wherein said administration of placental stem cells comprises subcutaneous administration.

18. The method of claim 1, wherein said administration of placental stem cells comprises parenteral administration.

20. The method of claim 1, comprising administering a second therapeutic agent to said individual.

21. The method of claim 20, wherein said second therapeutic agent is one or more of an anti-inflammatory agent, an immunosuppressant compound, or an antibiotic.

22. The method of claim 1, wherein said inflammatory bowel disease is ulcerative colitis.

23. The method of claim 1, wherein said inflammatory bowel disease is Crohn'"'"'s disease.

24. The method of claim 1, wherein said symptom is one or more of inflammation and swelling of a part of the gastrointestinal tract, abdominal pain, frequent emptying of the bowel, diarrhea, rectal bleeding, anemia, weight loss, arthritis, fever, thickening of the intestinal wall, formation of scar tissue in the intestines, formation of sores or ulcers in the intestine, development of one or more fistulas in the intestinal wall, or development of one or more fissures in the anus.

26. The method of claim 24, wherein said symptom is one or more of diarrhea, abdominal pain, inflammation and swelling of a part of the gastrointestinal tract, formation of scar tissue in the intestines, formation of sores or ulcers in the intestine, development of one or more fistulas in the intestinal wall, or development of one or more fissures in the anus.

27. The method of claim 1, wherein said placental stem cells are additionally one or more of CD45⁻

, CD133⁻

, CD13⁺, CD44⁺, CD90⁺, or HLA-G⁺, as detectable by flow cytometry.

28. The method of claim 1, wherein said placental stem cells are additionally CD45⁻

, CD133⁻

, CD13⁺, CD44⁺, CD90⁺, and HLA-G⁺, as detectable by flow cytometry.

2. A method of treating an individual having inflammatory bowel disease, comprising administering to the individual a therapeutically effective amount of non-hematopoietic placental stem cells, wherein said placental stem cells are CD34⁻

, CD10⁺, CD117⁻

, and CD105⁺, as detectable by flow cytometry, and adherent to tissue culture plastic, wherein the therapeutically effective amount is an amount sufficient to cause a detectable improvement in one or more symptoms of said inflammatory bowel disease, and wherein said administering is by intravenous, subcutaneous, or parenteral administration.

3. The method of claim 2, wherein said placental stem cells are additionally one or more of CD45⁻

, CD133⁻

, CD13⁺, CD44⁺, CD90⁺, or HLA-G⁺, as detectable by flow cytometry.

4. The method of claim 2, wherein said placental stem cells are additionally CD45⁻

, CD133⁻

, CD13⁺, CD44⁺, CD90⁺, and HLA-G⁺, as detectable by flow cytometry.

5. The method of claim 2, wherein said inflammatory bowel disease is ulcerative colitis.

6. The method of claim 2, wherein said inflammatory bowel disease is Crohn'"'"'s disease.

7. The method of claim 2, wherein said symptom is one or more of inflammation and swelling of a part of the gastrointestinal tract, abdominal pain, frequent emptying of the bowel, diarrhea, rectal bleeding, anemia, weight loss, arthritis, fever, thickening of the intestinal wall, formation of scar tissue in the intestines, formation of sores or ulcers in the intestine, development of one or more fistulas in the intestinal wall, or development of one or more fissures in the anus.

8. The method of claim 2, comprising administering a second therapeutic agent to said individual.

9. The method of claim 8, wherein said second therapeutic agent is one or more of an anti-inflammatory agent, an immunosuppressant compound, or an antibiotic.

11. The method of claim 2, wherein said administration of placental stem cells comprises intravenous administration.

13. The method of claim 2, wherein 1×

10⁸ to 5×

10⁸ placental stem cells are administered.

15. The method of claim 2, wherein between 1 million and 10 billion placental stem cells are administered.

17. The method of claim 2, wherein said administration of placental stem cells comprises subcutaneous administration.

19. The method of claim 2, wherein said administration of placental stem cells comprises parenteral administration.

25. The method of claim 7, wherein said symptom is one or more of diarrhea, abdominal pain, inflammation and swelling of a part of the gastrointestinal tract, formation of scar tissue in the intestines, formation of sores or ulcers in the intestine, development of one or more fistulas in the intestinal wall, or development of one or more fissures in the anus.