# US 9,872,877 B2 · Methods of using regenerative cells to promote epithelialization or neodermis formation

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- Number: US 9,872,877 B2
- Document ID: US9872877B2
- Status: Granted
- Kind: B2
- Application number: 15/203,684
- Filed: 2016-07-06
- Published: 2016-10-27
- Granted: 2018-01-23
- Earliest claimed: 2001-12-07
- Assignees: Cytori Therapeutics, Inc.
- Applicants: Cytori Therapeutics, Inc.
- Inventors: John K. Fraser; Marc H. Hedrick; Eric Daniels
- Web page: https://patentgrep.com/patent/US9872877B2

## CPC

- A61K 35/28: Bone marrow; Haematopoietic stem cells; Mesenchymal stem cells of any origin, e.g. adipose-derived stem cells
- 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)}
- 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)
- A61K 35/35: Fat tissue; Adipocytes; Stromal cells; Connective tissues (adipose-derived stem cells A61K35/28; collagen A61K38/39)
- A61K 35/36: Skin; Hair; Nails; Sebaceous glands; Cerumen; Epidermis; Epithelial cells; Keratinocytes; Langerhans cells; Ectodermal cells (islets of Langerhans A61K35/39)
- A61K 35/44: Vessels; Vascular smooth muscle cells; Endothelial cells; Endothelial progenitor cells
- A61K 38/1866: {Vascular endothelial growth factor [VEGF]}
- A61K 45/06: Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
- A61L 15/40: containing ingredients of undetermined constitution or reaction products thereof {, e.g. plant or animal extracts}
- A61L 15/44: Medicaments
- 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}
- A61L 27/3834: {Cells able to produce different cell types, e.g. hematopoietic stem cells, mesenchymal stem cells, marrow stromal cells, embryonic stem cells}
- A61L 27/54: Biologically active materials, e.g. therapeutic substances {(A61L27/227 takes precedence)}
- A61L 27/56: Porous materials, {e.g. foams or sponges}
- A61P 1/00: Drugs for disorders of the alimentary tract or the digestive system
- A61P 1/16: for liver or gallbladder disorders, e.g. hepatoprotective agents, cholagogues, litholytics
- A61P 3/00: Drugs for disorders of the metabolism (of the blood or the extracellular fluid A61P7/00)
- A61P 3/10: for hyperglycaemia, e.g. antidiabetics
- A61P 9/00: Drugs for disorders of the cardiovascular system
- A61P 9/10: for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis
- A61P 11/00: Drugs for disorders of the respiratory system
- A61P 13/12: of the kidneys
- A61P 17/00: Drugs for dermatological disorders
- A61P 17/02: for treating wounds, ulcers, burns, scars, keloids, or the like
- A61P 19/00: Drugs for skeletal disorders
- A61P 19/02: for joint disorders, e.g. arthritis, arthrosis
- A61P 21/00: Drugs for disorders of the muscular or neuromuscular system
- A61P 25/00: Drugs for disorders of the nervous system
- A61P 27/02: Ophthalmic agents
- A61P 37/06: Immunosuppressants, e.g. drugs for graft rejection
- C12N 5/0667: {Adipose-derived stem cells [ADSC]; Adipose stromal stem cells}
- C12N 5/069: {Vascular Endothelial cells}
- A61L 2300/412: Tissue-regenerating or healing or proliferative agents
- A61L 2300/64: Animal cells
- C12N 2506/1384: from adipose-derived stem cells [ADSC], from adipose stromal stem cells
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)
- A61L: METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES (preservation of bodies or disinfecting characterised by the agents employed A01N; preserving, e.g. sterilising, food or foodstuffs A23; preparations for medical, dental or toiletry purposes A61K)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- C12N: MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA (microbiological testing media C12Q1/00)

## 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

### Claim 1

A method of inducing epithelialization or neodermis formation at a wound of the skin of a subject, comprising:
identifying a subject with an 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 wound, wherein said concentrated population of adipose-derived regenerative cells is obtained by acquiring an adipose tissue sample, separating away adipocytes and connective tissue, and washing and concentrating said adipose-derived regenerative cells.

### Claim 2 (depends on 1)

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

### Claim 3 (depends on 1)

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.

### Claim 4 (depends on 1)

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

### Claim 5 (depends on 1)

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

### Claim 6 (depends on 1)

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

### Claim 7 (depends on 1)

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

### Claim 8 (depends on 1)

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

### Claim 9 (depends on 1)

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

### Claim 10 (depends on 1)

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

### Claim 11 (depends on 1)

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 adipose-derived regenerative cells comprising adipose-derived stem and endothelial progenitor cells to be removed from said adipose tissue processing unit;
obtaining the concentrated population of adipose-derived regenerative cells from said self-contained adipose tissue processing unit.

### Claim 12 (depends on 1)

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.

### Claim 13 (depends on 1)

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

### Claim 14 (depends on 13)

The method of claim 13, wherein said additive is selected from the group consisting of a cell differentiation factor, a growth promoter, an immunosuppressive agent, a medical device, or a combination thereof.

### Claim 15 (depends on 13)

The method of claim 13, wherein said additive is selected from the group consisting of other cells, tissue, and tissue fragments.

### Claim 16 (depends on 13)

The method of claim 13, wherein said additive comprises an angiogenic factor, or an arteriogenic factor.

### Claim 17 (depends on 1)

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

### Claim 18 (depends on 1)

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

### Claim 19 (depends on 1)

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

### Claim 20 (depends on 1)

The method of claim 1, wherein the concentrated population of adipose-derived regenerative cells is cryopreserved.