Treatment of amyotrophic lateral sclerosis using placental stem cells

• US 9,925,221 B2
• Filed: 09/10/2012
• Issued: 03/27/2018
• Est. Priority Date: 09/09/2011
• Status: Active Grant

• Current Assignee: Celularity, Inc.
• Original Assignee: Celularity, Inc.
• Inventors: Hariri, Robert J., Gurney, Jodi P.
• Primary Examiner(s): LI, QIAN JANICE
• Application Number:
  US14/343,283
• Publication Number:
  US 20150044177A1
• Time in Patent Office: 2,024 Days
• Field of Search: None
• 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

Abstract

Provided herein are methods of treatment of an individual having amyotrophic lateral sclerosis, comprising administering to the individual a therapeutically effective amount of placental stem cells, e.g., tissue culture surface-adherent placental stem cells (PDACs). In one aspect, provided herein is a method of treating amyotrophic lateral sclerosis (ALS) comprising administering to an individual having ALS a therapeutically effective amount of placental stem cells. In certain embodiments, “therapeutically effective” means an amount effective to reduce or ameliorate one or more symptoms of ALS.

Claims

1. A method of treating an individual having amyotrophic lateral sclerosis (ALS), comprising administering to the individual a therapeutically effective amount of placental stem cells, wherein the therapeutically effective amount is an amount sufficient to detectably reduce or ameliorate one or more symptoms of said ALS, and wherein administration occurs twice per month every one, two, or three months.

2. The method of claim 1, further comprising monitoring one or more of said symptoms in said patient;

and administering a second dose of placental stem cells when said one or more symptoms begins to worsen.

3. The method of claim 1, wherein said one or more symptoms comprise difficulty lifting the front part of the foot;

difficulty lifting the toes;

weakness in one or both legs;

weakness in one or both feet;

weakness in one or both ankles;

hand weakness;

hand clumsiness;

slurring of speech;

trouble swallowing;

muscle cramps;

twitching in one or both arms;

twitching in one or both shoulders and/or twitching of the tongue.

4. The method of claim 1, additionally comprising administering a second therapeutic composition, wherein said second therapeutic composition is riluzole, ceftriaxone, dexpramipexole, creatine+tamoxifen, rasagiline, pioglitazone, arimoclomol, pyrimethamine, trantinoin+pioglitazone, or an antisense molecule or interfering RNA directed against an RNA encoding superoxide dismutase.

5. The method of claim 2, wherein said monitoring comprises monitoring over between 1 and 7 days post-administration.

6. The method of claim 2, wherein said monitoring comprises monitoring over between 7 and 28 days post administration.

7. The method of claim 2, wherein said monitoring comprises monitoring over between 1 and 28 weeks post-administration.

8. The method of claim 1, wherein said placental stem cells are CD10⁺, CD34⁻

, CD105⁺ placental stem cells.

9. The method of claim 8, wherein said placental stem cells are additionally CD200⁺.

10. The method of claim 8, wherein said placental stem cells are additionally CD45⁻

and CD90⁺.

11. The method of claim 8, wherein said placental stem cells are additionally CD80⁻

and CD86⁻

.

12. The method of claim 1 or claim 2, wherein said placental stem cells express CD200 and do not express HLA-G;

or express CD73, CD105, and CD200;

or express CD200 and OCT-4;

or express CD73 and CD105 and do not express HLA-G.

13. The method of claim 8, wherein said placental stem cells are HLA-A,B,C⁺.

14. The method of claim 1, wherein said placental stem cells are formulated to be administered locally.

15. The method of claim 1, wherein said placental stem cells are formulated to be administered systemically, intravenously, intraarterially, subcutaneously, or intrathecally.

16. The method of claim 1, wherein said therapeutically effective amount comprises at least 1×

10⁷ placental stem cells per administration.

17. The method of claim 1, wherein said therapeutically effective amount comprises at least 1×

10⁸ placental stem cells per administration.

18. The method of claim 1, wherein said therapeutically effective amount comprises at least 2×

10⁸ placental stem cells per administration.

19. The method of claim 1, wherein said therapeutically effective amount comprises at least 1×

10⁹ placental stem cells per administration.

20. The method of claim 2, wherein said placental stem cells are CD10⁺, CD34⁻

, CD105⁺, and CD200⁺.