Methods of using regenerative cells to treat an ischemic wound

• US 9,511,096 B2
• Filed: 02/14/2014
• Issued: 12/06/2016
• Est. Priority Date: 12/07/2001
• Status: Expired due to Term

• Current Assignee: Lorem Vascular Pte. Ltd.
• Original Assignee: Cytori Therapeutics Incorporated
• Inventors: Fraser, John K., Hedrick, Marc H., Daniels, Eric
• Primary Examiner(s): Lankford, Blaine
• Application Number:
  US14/180,553
• Publication Number:
  US 20140227234A1
• Time in Patent Office: 1,026 Days
• Field of Search: None
• US Class Current: 1/1
• 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 35/12 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 35/28 Bone marrow; Haematopoietic stem cells; Mesenchymal stem cells of any origin, e.g. adipose-derived stem cells
• CPC Class Codes: A61K 35/35 Fat tissue; Adipocytes; Stromal cells; Connective tissues adipose-derived stem cells A61K35/28; collagen A61K38/39
• CPC Class Codes: A61K 35/36 Skin; Hair; Nails; Sebaceous glands; Cerumen; Epidermis; Epithelial cells; Keratinocytes; Langerhans cells; Ectodermal cells islets of Langerhans A61K35/39
• CPC Class Codes: A61K 35/44 Vessels; Vascular smooth muscle cells; Endothelial cells; Endothelial progenitor cells
• CPC Class Codes: A61K 38/1866 Vascular endothelial growth factor [VEGF]
• CPC Class Codes: A61K 45/06 Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
• CPC Class Codes: A61K 9/0014 Skin, i.e. galenical aspects of topical compositions non-active ingredients are additionally classified in A61K47/00; A61K9/0009, A61K9/0021, A61K9/7015, A61K9/7023 take precedence; cosmetic preparations A61K8/00, A61Q; preparations for wound dressings or bandages A61L26/00
• CPC Class Codes: A61L 15/40 containing ingredients of undetermined constitution or reaction products thereof , e.g. plant or animal extracts
• CPC Class Codes: A61L 15/44 Medicaments
• CPC Class Codes: A61L 2300/412 Tissue-regenerating or healing or proliferative agents
• CPC Class Codes: A61L 2300/64 Animal cells
• CPC Class Codes: A61L 27/3604 characterised by the human or animal origin of the biological material, e.g. hair, fascia, fish scales, silk, shellac, pericardium, pleura, renal tissue, amniotic membrane, parenchymal tissue, fetal tissue, muscle tissue, fat tissue, enamel
• CPC Class Codes: A61L 27/3834 Cells able to produce different cell types, e.g. hematopoietic stem cells, mesenchymal stem cells, marrow stromal cells, embryonic stem cells
• CPC Class Codes: A61L 27/54 Biologically active materials, e.g. therapeutic substances A61L27/227 takes precedence
• CPC Class Codes: A61L 27/56 Porous materials, e.g. foams or sponges
• CPC Class Codes: A61P 1/00 Drugs for disorders of the alimentary tract or the digestive system
• CPC Class Codes: A61P 1/16 for liver or gallbladder disorders, e.g. hepatoprotective agents, cholagogues, litholytics
• CPC Class Codes: A61P 11/00 Drugs for disorders of the respiratory system
• CPC Class Codes: A61P 13/12 : of the kidneys
• 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 19/00 : Drugs for skeletal disorders
• CPC Class Codes: A61P 19/02 : for joint disorders, e.g. arthritis, arthrosis
• 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 27/02 : Ophthalmic agents
• CPC Class Codes: A61P 3/00 : Drugs for disorders of the metabolism of the blood or the extracellular fluid A61P7/00
• CPC Class Codes: A61P 3/10 : for hyperglycaemia, e.g. antidiabetics
• CPC Class Codes: A61P 37/06 : Immunosuppressants, e.g. drugs for graft rejection
• 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 2506/1384 : from adipose-derived stem cells [ADSC], from adipose stromal stem cells
• CPC Class Codes: C12N 5/0667 : Adipose-derived stem cells [ADSC]; Adipose stromal stem cells
• CPC Class Codes: C12N 5/069 : Vascular Endothelial cells

Abstract

Cells present in adipose tissue are used to promote wound healing in a patient. Methods of treating patients include processing adipose tissue to deliver a concentrated amount of regenerative cells obtained from the adipose tissue to a patient. The methods may be practiced in a closed system so that the regenerative cells are not exposed to an external environment prior to being administered to a patient. Accordingly, in a preferred method, cells present in adipose tissue are placed directly into a recipient along with such additives necessary to promote, engender or support a therapeutic benefit.

Claims

1. A method of treating an ischemic wound in a subject in need thereof, comprising:

identifying a subject with an ischemic wound; and

administering a therapeutically effective amount of a concentrated population of adipose-derived regenerative cells comprising adipose-derived stem cells and endothelial progenitor cells to said subject sufficient to accelerate the healing of said ischemic wound, wherein said concentrated population of adipose-derived regenerative cells is obtained by acquiring an adipose tissue sample, separating away the adipocytes and connective tissue, and washing and concentrating said adipose-derived regenerative cells.

2. The method of claim 1, wherein the concentrated population of adipose-derived regenerative cells has not been cultured.

3. The method of claim 1, wherein the concentrated population of adipose-derived regenerative cells is obtained from adipose tissue of the subject to whom the cells are administered.

4. The method of claim 1, wherein said administering step comprises applying the concentrated population of adipose-derived regenerative cells directly to the ischemic wound.

5. The method of claim 1, wherein the ischemic wound is a diabetic ulcer.

6. The method of claim 1, wherein the subject has peripheral vascular disease.

7. The method of claim 1, wherein the subject has ischemic bowel disease.

8. The method of claim 1, wherein said administering step comprises subcutaneous delivery.

9. The method of claim 1, wherein said administering step comprises dermal delivery.

10. The method of claim 1, wherein the subject is obese.

11. The method of claim 1, wherein the ischemic wound is an ischemic stroke.

12. The method of claim 1, wherein the ischemic wound is an ischemic cardiomyopathy.

13. The method of claim 1, wherein the subject has rheumatoid arthritis.

14. The method of claim 1, wherein the subject has lymphedema.

15. The method of claim 1, wherein said administration step comprises administering multiple doses of said concentrated population of adipose-derived regenerative cells.

16. The method of claim 1, further comprising:

providing adipose tissue to a self-contained adipose tissue processing unit comprising;

a tissue collecting container configured to receive and fully or partially disaggregate adipose tissue, wherein said tissue collecting container is coupled to a cell collection container wherein said coupling defines a closed system in which said fully or partially disaggregated adipose tissue directed from tissue collecting container to cell collection container is not exposed to the external environment; and

wherein said cell collection container, further comprises a cell concentrator that facilitates separation of the cells in a suspension; and

an outlet that is structured to permit said concentrated population of cells comprising adipose-derived cells to be removed from said adipose tissue processing unit; and

obtaining the concentrated population of cells comprising adipose-derived regenerative cells from said self-contained adipose tissue processing unit.

17. The method of claim 1, wherein the therapeutically effective amount of the concentrated population of adipose-derived regenerative cells comprises a minimum concentration of between 1×

10⁵ and 1×

10⁷ adipose-derived stem cells.

18. The method of claim 1, wherein the concentrated population of adipose-derived regenerative cells further comprises an additive.

19. The method of claim 16, wherein said additive is selected from the group consisting of a cell differentiation factor, a growth promoter, an immunosuppressive agent, and a medical device, or a combination thereof.

20. The method of claim 16, wherein said additive is selected from the group consisting of other cells, tissue, and tissue fragments.

21. The method of claim 16, wherein said additive comprises an angiogenic factor, or an arteriogenic factor.

22. The method of claim 1, wherein said concentrated population of adipose-derived regenerative cells further comprises endothelial precursor cells.

23. The method of claim 1, wherein said concentrated population of adipose-derived regenerative cells is applied to a biocompatible matrix.

24. The method of claim 1, wherein said concentrated population of adipose-derived regenerative cells is applied to a bandage.

25. The method of claim 1, wherein said concentrated population of adipose-derived regenerative cells in not exposed to the external environment prior to the administration step.