Methods of using regenerative cells to promote wound healing

• US 8,691,216 B2
• Filed: 01/27/2012
• Issued: 04/08/2014
• Est. Priority Date: 12/07/2001
• Status: Expired due to Fees

• 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:
  US13/360,022
• Publication Number:
  US 20120121556A1
• Time in Patent Office: 802 Days
• Field of Search: None
• US Class Current: 424/93.7
• 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 inducing epithelialization or neodermis formation at a wound of the skin of a subject, comprising:

identifying a subject with a wound;

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;

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

contacting said wound with a therapeutically effective amount of the concentrated population of adipose-derived cells comprising regenerative cells, wherein the concentrated population of adipose-derived cells has not been cultured prior to contacting the wound.

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

10⁵ and 1×

10⁷ adipose-derived stem cells.

3. The method of claim 1, wherein the concentrated population of adipose-derived cells comprising regenerative cells has not been exposed to the external environment prior to the contacting step.

4. The method of claim 1, wherein the concentrated population of adipose-derived cells comprising regenerative cells further comprises progenitor cells.

5. The method of claim 1, wherein the concentrated population of adipose-derived cells comprising regenerative cells further comprises endothelial precursor cells.

6. The method of claim 1, wherein the concentrated population of adipose-derived cells comprising regenerative cells further comprises an additive selected from the group consisting of an angiogenic factor, an arteriogenic factor, an immunosuppressive agent, and an antimicrobial agent.

7. The method of claim 6, wherein said additive comprises VEGF.

8. The method of claim 1, wherein said concentrated population of adipose-derived cells comprising regenerative cells is isolated from adipose tissue obtained from the same subject that has the wound.

9. The method of claim 1, wherein the wound is selected from the group consisting of a skin wound following surgery, a skin abrasion caused by mechanical trauma, a skin abrasion caused by caustic agents, a burn, an abrasion to the cornea, a mucosal epithelium wound following infection or drug therapy, a diabetic ulcer, a skin wound following grafting, an ischemic ulcer wound, and traumatic wound.

10. The method of claim 1, wherein the wound comprises an ischemic ulcer.

11. The method of claim 1, wherein the wound is contacted with multiple doses of the concentrated population of adipose-derived cells comprising regenerative cells.

12. The method of claim 11, wherein each dose provides a minimum concentration of between 1×

10⁵ and 1×

10⁷ adipose-derived stem cells.

13. The method of claim 1, wherein the concentrated population of adipose-derived cells comprising regenerative cells is administered to the wound in a bolus.

14. The method of claim 13, wherein the bolus provides a minimum concentration of between 1×

10⁵ and 1×

10⁷ adipose-derived regenerative cells.

15. The method of claim 13, wherein the concentrated population of adipose-derived cells comprising regenerative cells is injected into a subcutaneous or dermal site.

16. The method of claim 1, wherein the concentrated population of adipose-derived cells comprising regenerative cells is provided on a scaffold or bandage.

17. The method of claim 1, wherein the concentrated population of adipose-derived cells comprising regenerative cells is provided on a resorbable scaffold.

18. The method of claim 1, wherein the concentrated population of adipose-derived cells comprising regenerative cells further comprises a tissue fragment.

19. The method of claim 1, wherein the concentrated population of adipose-derived cells comprising regenerative cells further comprises intact adipose tissue.

20. The method of claim 9, wherein the wound is a burn.