Treatment of limb ischemia

• US 9,410,122 B2
• Filed: 08/04/2014
• Issued: 08/09/2016
• Est. Priority Date: 02/06/2009
• Status: Active Grant

• Current Assignee: ReNeuron Limited (ReNeuron Group Plc)
• Original Assignee: ReNeuron Limited (ReNeuron Group Plc)
• Inventors: Sinden, John, Miljan, Erik, Madeddu, Paolo
• Primary Examiner(s): Long, Scott
• Application Number:
  US14/450,733
• Publication Number:
  US 20140341868A1
• Time in Patent Office: 736 Days
• US Class Current: 1/1
• CPC Class Codes: A61K 35/12 Materials from mammals; Compositions comprising non-specified tissues or cells; Compositions comprising non-embryonic stem cells; Genetically modified cells vaccines or medicinal preparations containing antigens or antibodies A61K39/00
• CPC Class Codes: A61K 35/30 Nerves; Brain; Eyes; Corneal cells; Cerebrospinal fluid; Neuronal stem cells; Neuronal precursor cells; Glial cells; Oligodendrocytes; Schwann cells; Astroglia; Astrocytes; Choroid plexus; Spinal cord tissue
• 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 2510/04 Immortalised cells
• CPC Class Codes: C12N 5/0623 Stem cells

Abstract

The present invention uses neural stem cells in the manufacture of a medicament for the treatment of a patient suffering peripheral arterial disease. The invention is particularly suited for treating limb ischemia or Buerger'"'"'s disease.

Claims

1. A method for treating peripheral arterial disease in a patient, comprising administering a therapeutic dose of neural stem cells to the patient;

wherein, prior to administration, the neural stem cells are (i) suspended in a composition that comprises Trolox, Na⁺, K⁺, Ca²⁺, mg²⁺, Cl⁻

, H₂PO₄⁻

, HEPES, lactobionate, sucrose, mannitol, glucose, dextran-40, adenosine and glutathione and does not include a dipolar aprotic solvent, (ii) preserved at cryothermic temperatures below −

20°

C., and (iii) thawed; and

wherein the cells are administered directly to the patient following thawing without any further processing steps.

2. The method according to claim 1, wherein the disease is limb ischemia or Buerger'"'"'s disease.

3. The method according to claim 2, wherein the disease is critical limb ischemia.

4. The method according to claim 2, wherein the disease is acute limb ischemia.

5. The method according to claim 1, wherein the disease is associated with diabetes.

6. The method according to claim 1, wherein the neural stem cells are administered in a formulation, and wherein the formulation is in a form for intravenous or intramuscular delivery.

7. The method according to claim 1, wherein the cells are pluripotent neuroepithelial cells.

8. The method according to claim 1, wherein the cells are human cells.

9. The method according to claim 1, wherein the cells are adult cells.

10. The method according to claim 1, wherein the cells are conditionally immortalized.

11. The method according to claim 10, wherein the cells are immortalized by incorporation of a temperature-sensitive oncogene.

12. The method according to claim 11, wherein the oncogene encodes the SV40 T antigen.

13. The method according to claim 11, wherein the oncogene is myc.

14. The method according to claim 13, wherein the oncogene is c-mycER.

15. The method according to claim 11, wherein the cells are those designated as CTX0E03.

16. The method according to claim 1, wherein the patient is human.

17. A method for treating peripheral arterial disease in a patient, comprising

(i) suspending neural stem cells in a composition comprising Trolox, Na⁺, K⁺, Ca²⁺, mg²⁺, Cl⁻

, H₂PO₄⁻

, HEPES, lactobionate, sucrose, mannitol, glucose, dextran-40, adenosine, and glutathione and does not include a dipolar aprotic solvent;

(ii) preserving the suspended neural stem cells at cryothermic temperatures below −

20°

C.;

(iii) thawing the stored or preserved neural stem cells; and

(iv) administering the thawed neural stem cells directly to the patient following thawing without any further processing steps.