Methods of using regenerative cells in the treatment of cartilage defects

• US 9,463,203 B2
• Filed: 08/18/2014
• Issued: 10/11/2016
• Est. Priority Date: 12/07/2001
• Status: Expired due to Fees

• Current Assignee: Lorem Vascular Pte. Ltd.
• Original Assignee: Cytori Therapeutics Incorporated
• Inventors: Hedrick, Marc H., Fraser, John K., Riley, Susan L., Schreiber, Ronda E.
• Primary Examiner(s): Lankford, Blaine
• Application Number:
  US14/462,392
• Publication Number:
  US 20150023931A1
• Time in Patent Office: 785 Days
• Field of Search: None
• US Class Current: 1/1
• 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: A61L 2300/40 characterised by a specific therapeutic activity or mode of action
• 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 2400/06 Flowable or injectable implant compositions
• CPC Class Codes: A61L 2430/02 for reconstruction of bones; weight-bearing implants
• CPC Class Codes: A61L 2430/06 for cartilage reconstruction, e.g. meniscus
• CPC Class Codes: A61L 2430/40 Preparation and treatment of biological tissue for implantation, e.g. decellularisation, cross-linking
• CPC Class Codes: A61L 27/18 obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
• CPC Class Codes: A61L 27/3608 Bone, e.g. demineralised bone matrix [DBM], bone powder
• CPC Class Codes: A61L 27/365 Bones
• CPC Class Codes: A61L 27/3654 Cartilage, e.g. meniscus
• CPC Class Codes: A61L 27/3691 characterised by physical conditions of the treatment, e.g. applying a compressive force to the composition, pressure cycles, ultrasonic/sonication or microwave treatment, lyophilisation
• 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 27/3847 Bones
• CPC Class Codes: A61L 27/3852 Cartilage, e.g. meniscus
• CPC Class Codes: A61L 27/3895 using specific culture conditions, e.g. stimulating differentiation of stem cells, pulsatile flow conditions
• CPC Class Codes: A61L 27/52 Hydrogels or hydrocolloids
• 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 19/02 : for joint disorders, e.g. arthritis, arthrosis
• CPC Class Codes: A61P 19/04 : for non-specific disorders of the connective tissue
• CPC Class Codes: A61P 19/08 : for bone diseases, e.g. rachitism, Paget's disease
• CPC Class Codes: C12N 5/0667 : Adipose-derived stem cells [ADSC]; Adipose stromal stem cells

Abstract

Regenerative cells present in adipose tissue are used to treat patients, including patients with musculoskeletal diseases or disorders. 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 stem cells are not exposed to an external environment prior to being administered to a patient. Accordingly, in a preferred method, regenerative cells present in adipose tissue are placed directly into a recipient along with such additives necessary to promote, engender or support a therapeutic musculoskeletal benefit.

Claims

1. A method of treating a cartilage defect in subject in need thereof, comprising:

identifying a subject with a cartilage defect; 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 cartilage defect, wherein the concentrated population of adipose-derived regenerative cells has not been cultured, and 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.

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

3. The method of claim 1, wherein said cartilage defect comprises osteoarthritis.

4. The method of claim 1, wherein said cartilage defect is a defect in the articular cartilage.

5. The method of claim 1, wherein said cartilage defect is a defect in the meniscal fibrocartilage.

6. The method of claim 1, wherein said cartilage defect is a defect in the knee.

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

8. 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 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.

9. 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.

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

11. The method of claim 9, 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.

12. The method of claim 9, wherein said additive is selected from the group consisting of other cells, tissue, and tissue fragments.

13. The method of claim 9, wherein said additive comprises an angiogenic factor, an arteriogenic factor.

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

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

16. The method of claim 15, wherein said biocompatible matrix is a synthetic or biological scaffold.

17. The method of claim 1, further comprising:

performing lipoaspiration to obtain adipose tissue from said subject; and

processing said adipose tissue to obtain said concentrated population of adipose-derived regenerative cells.

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

19. The method of claim 1, wherein said concentrated population of adipose-derived cells is administered via an artificial or natural tissue scaffold.

20. 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.