Treatment of sarcoidosis using placental stem cells

• US 8,562,973 B2
• Filed: 04/06/2011
• Issued: 10/22/2013
• Est. Priority Date: 04/08/2010
• Status: Active Grant

• Current Assignee: Celularity, Inc.
• Original Assignee: Anthrogenesis Corporation (Bristol-Myers Squibb Company)
• Inventors: Edinger, James W., Francki, Aleksandar, Jankovic, Vladimir, Liang, Bitao, Ray, Cynthia, Zhang, Xiaokui, Fischkoff, Steven Alan, Martin, Philippe
• Primary Examiner(s): Hanley, Susan
• Assistant Examiner(s): NGUYEN, NGHI V
• Application Number:
  US13/081,422
• Publication Number:
  US 20110311491A1
• Time in Patent Office: 930 Days
• Field of Search: 424/93.7, 424/583
• US Class Current: 424/93.7
• CPC Class Codes: A61K 35/50 Placenta; Placental stem cells; Amniotic fluid; Amnion; Amniotic stem cells
• CPC Class Codes: A61K 45/06 Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
• CPC Class Codes: A61P 1/14 Prodigestives, e.g. acids, enzymes, appetite stimulants, antidyspeptics, tonics, antiflatulents
• CPC Class Codes: A61P 11/00 Drugs for disorders of the respiratory system
• CPC Class Codes: A61P 11/02 Nasal agents, e.g. decongestants
• CPC Class Codes: A61P 11/14 Antitussive agents
• CPC Class Codes: A61P 17/00 Drugs for dermatological disorders
• CPC Class Codes: A61P 17/02 for treating wounds, ulcers, burns, scars, keloids, or the like
• 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 27/02 Ophthalmic agents
• 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 3/02 Nutrients, e.g. vitamins, minerals
• CPC Class Codes: A61P 37/00 Drugs for immunological or allergic disorders
• CPC Class Codes: A61P 43/00 Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
• CPC Class Codes: A61P 9/00 Drugs for disorders of the cardiovascular system
• CPC Class Codes: A61P 9/10 for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis

Abstract

Methods of treating individuals having sarcoidosis or a sarcoidosis-related disease or disorder using placental cells are described. Also describe are kits comprising placental stem cells or a composition thereof that can be used in methods of treating sarcoidosis or a sarcoidosis-related disease or disorder.

Claims

1. A method of treating an individual having sarcoidosis comprising administering to the individual a therapeutically effective amount of placental stem cells, wherein the therapeutically effective amount is an amount sufficient to cause a detectable improvement in one or more symptoms of said sarcoidosis and wherein said sarcoidosis is systemic sarcoidosis, cutaneous sarcoidosis, Lö

fgren'"'"'s syndrome, neurosarcoidosis, cardiac sarcoidosis, or ocular sarcoidosis.

2. The method of claim 1, wherein said placental stem cells are CD10⁺, CD34³¹ , CD105⁺, CD200⁺placental stem cells.

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

or CD90⁺.

4. The method of claim 2, wherein said placental stem cells are additionally one or more of CD38⁻

, CD45⁻

, CD80⁻

, CD86⁻

, CD133⁻

, HLA-DR,DP,DQ⁻

, SSEA3⁻

, SSEA4⁻

, CD29⁺, CD44⁺, CD73⁺, CD90⁺, HLA-A,B,C⁺, PDL1⁺, ABC-p⁺,or OCT-4⁺.

5. The method of claim 2, wherein said placental stem cells are additionally one or more of CD29⁺, CD38⁺, CD44⁺, CD54⁺, SH3⁺or SH4⁺.

6. The method of claim 2, wherein said placental stem cells are additionally CD44⁺.

7. The method of claim 1, wherein said placental stem cells express CD200 and do not express HLA-G, or express CD73, CD 105, and CD200, or express CD200 and OCT-4, or express CD73 and CD 105 and do not express HLA-G, or express CD73 and CD105 and facilitate the formation of one or more embryoid-like bodies in a population of placental cells comprising said stem cell when said population is cultured under conditions that allow for the formation of an embryoid-like body, or express OCT-4 and facilitate the formation of one or more embryoid-like bodies in a population of placental cells comprising said stem cell when said population is cultured under conditions that allow for the formation of an embryoid-like body.

8. The method of claim 1, wherein said sarcoidosis is systemic sarcoidosis.

9. The method of claim 8, wherein said symptom is one or more of formation of granulomas, fatigue, weight loss, fever, aches, pains, arthritis, dry eyes, swelling of the knees, blurry vision, shortness of breath, cough and skin lesions.

10. The method of claim 1, wherein said sarcoidosis is cutaneous sarcoidosis.

11. The method of claim 10, wherein the cutaneous sarcoidosis comprises annular sarcoidosis, erythrodermic sarcoidosis, ichthyosiform sarcoidosis, hypopigmented sarcoidosis, morpheaform sarcoidosis, mucosal sarcoidosis, papular sarcoid, scar sarcoid, subcutaneous sarcoidosis or ulcerative sarcoidosis.

12. The method of claim 11, wherein said symptom is a skin lesion.

13. The method of claim 12, wherein the skin lesion is one or more of erythema nodosum, nummular eczema, erythema multiforme, calcinosis cutis and pruritus, lupus pernio, skin plaques, maculopapular eruptions, nodular lesions deeper in the skin or infiltration of old scars.

14. The method of claim 1, wherein said sarcoidosis is Lö

fgren'"'"'s syndrome.

15. The method of claim 14, wherein said symptom is one or more of erythema nodosum, bilateral hilar denopathy, arthritis, arthralgias or fever.

16. The method of claim 1, wherein said sarcoidosis is neurosarcoidosis.

17. The method of claim 16, wherein said symptom is one or more of formation of granulomas in the nervous system, headache, confusion, malaise or facial paralysis.

18. The method of claim 1, wherein said sarcoidosis is cardiac sarcoidosis.

19. The method of claim 18, wherein said symptom is one or more of chest pain, palpitations, congestive heart failure, pericarditis or papillary muscle dysfunction, shortness of breath, ankle swelling, irregular heart beat or sudden death.

20. The method of claim 1, wherein said sarcoidosis is ocular sarcoidosis.

21. The method of claim 20, wherein said symptom is one or more of red or watery eyes, granulomatous uvetis, iris nodules, retinochoroiditis, conjunctivitis, lacrimal gland involvement or proptosis.

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

23. The method of claim 22, wherein said second therapeutic agent is an anti-inflammatory agent, a steroid, an immunosuppressant compound, or an antibiotic.