Use of umbilical cord blood to treat individuals having a disease, disorder or condition

• US 20070053888A1
• Filed: 11/06/2006
• Published: 03/08/2007
• Est. Priority Date: 02/13/2003
• Status: Abandoned Application

• Current Assignee: Celularity, Inc.
• Original Assignee: Celularity, Inc.
• Inventors: Hariri, Robert
• Application Number:
  US11/593,348
• Publication Number:
  US 20070053888A1
• Time in Patent Office: Days
• US Class Current: 424/93.700
• CPC Class Codes: A61K 2035/124 the cells being hematopoietic, bone marrow derived or blood cells
• CPC Class Codes: A61K 35/44 Vessels; Vascular smooth muscle cells; Endothelial cells; Endothelial progenitor cells
• CPC Class Codes: A61K 35/51 Umbilical cord; Umbilical cord blood; Umbilical stem cells
• CPC Class Codes: A61P 17/02 for treating wounds, ulcers, burns, scars, keloids, or the like
• CPC Class Codes: A61P 21/00 Drugs for disorders of the muscular or neuromuscular system
• 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 25/16 Anti-Parkinson drugs
• 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 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
• CPC Class Codes: C12N 5/0607 Non-embryonic pluripotent stem cells, e.g. MASC induced pluripotent stem cells C12N5/0696

Abstract

The present invention provides methods of using cord blood and cord blood-derived stem cells in high doses to treat various conditions, diseases and disorders. The high-dose cord blood and cord blood-derived stem cells have a multitude of uses and applications, including but not limited to, therapeutic uses for transplantation and treatment and prevention of disease, and diagnostic and research uses. In particular, the cord blood or cord blood-derived stem cells are delivered in high doses, e.g., at least 3 billion nucleated cells per treatment, where treatment may comprise a single or multiple infusions. The invention also provides for the use of cord blood or cord blood-derived stem cells from multiple donors without the need for HLA typing.

Claims

1. A method of treating an individual comprising administration of a composition comprising cord blood or cord blood-derived stem cells, wherein said administration delivers at least 1×

10¹⁰ total nucleated cells, or at least 1×

10⁹ stem cells, to an individual in need of said administration.

2. The method of claim 1 wherein the cord blood or cord blood-derived stem cells are suitable for bone marrow transplantation.

3. The method of claim 2 wherein the cord blood or cord blood-derived stem cells are suitable for administration in humans.

4. The method of claim 2 wherein a plurality of the cord blood-derived stem cells express the cell surface markers CD34⁺ and CD38⁻

.

5. The method of claim 2 wherein a plurality of the umbilical cord blood stem cells express the cell surface markers CD34+ and CD38+.

6. The method of claim 2 additionally comprising contacting the cord blood or cord blood-derived stem cells with a growth factor.

7. The method of claim 6 wherein the growth factor is a cytokine, lymphokine, interferon, colony stimulating factor (CSF), interferon, chemokine, interleukin, human hematopoietic growth factor, hematopoietic growth factor ligand, stem cell factor, thrombopoietin (Tpo), granulocyte colony-stimulating factor (G-CSF), leukemia inhibitory factor, basic fibroblast growth factor, placenta derived growth factor or epidermal growth factor.

8. The method of claim 6 wherein the cord blood or cord blood-derived stem cells are contacted with the growth factor to induce differentiation into a plurality of cell types.

9. The method of claim 6 wherein the cord blood or cord blood-derived stem cells are contacted with the growth factor to prevent or suppress differentiation into a particular cell type.

11. The method of claim 1 wherein said administration delivers at least 3×

10¹⁰ total nucleated cells or at least 3×

10⁹ stem cells.

13. The method of claim 1 wherein said administration delivers at least 2×

10¹⁰ total nucleated cells or at least 2×

10⁹ stem cells.

14. The method of claim 1 wherein said individual has a disease, disorder or condition that includes an inflammation component.

15. The method of claim 1 wherein said individual has a vascular disease, disorder or condition.

16. The method of claim 15 wherein said disease, disorder or condition is atherosclerosis.

17. The method of claim 1 wherein said individual has a neurological disease, disorder or condition.

18. The method of claim 17, wherein said disease, disorder or condition is selected from the group consisting of amyotrophic lateral sclerosis and multiple sclerosis.

21. The method of claim 1, wherein said individual has undergone a trauma or injury.

22. The method of claim 21, where said trauma or injury is trauma or injury to the central nervous system.

23. The method of claim 21, wherein said trauma or injury is trauma or injury to the peripheral nervous system.

24. The method of claim 1, wherein said at least 1×

10¹⁰ total nucleated cells, or at least 1×

10⁹ stem cells, comprises cells derived from a plurality of donors.

25. The method of claim 1 wherein none of said cells in said composition is HLA-typed prior to said administration.

26. The method of claim 1 wherein said composition is preconditioned for between 18 hours and 21 days prior to said administration.

27. The method of claim 1 wherein said composition is preconditioned for between 48 hours and 10 days prior to said administration.

28. The method of claim 1, wherein said composition is preconditioned for between 3-5 days prior to said administration.

10. A method of treating myelodysplasia which comprises administering cord blood or cord blood-derived stem cells to a patient in need thereof.

12. (canceled)

19. (canceled)

20. (canceled)