METHODS OF USING REGENERATIVE CELLS IN THE TREATMENT OF MUSCULOSKELETAL DISORDERS

• US 20100303774A1
• Filed: 08/09/2010
• Published: 12/02/2010
• Est. Priority Date: 12/07/2001
• Status: Active Grant

• Current Assignee: Lorem Vascular Pte. Ltd.
• Original Assignee: Cytori Therapeutics Incorporated
• Inventors: Schreiber, Ronda Elizabeth, Fraser, John K., Hedrick, Marc H., Riley, Susan Lynn
• Granted Patent: US 9,504,716 B2
• Time in Patent Office: Days
• US Class Current: 424/93.7
• 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 for promoting bone, cartilage, skeletal muscle, tendon, ligament or proteoglycan-rich matrix formation in a subject comprising:

identifying a subject with a musculoskeletal disorder;

obtaining a unit of adipose tissue from said subject;

processing said unit of adipose tissue obtained from said subject to obtain a concentrated population of cells that comprises adipose-derived stem cells;

mixing said concentrated population of cells that comprises adipose-derived stem cells in a hydrogel liquid; and

introducing the mixture of the concentrated population of cells that comprises adipose-derived stem cells into said subject by injection at a site where bone, cartilage, skeletal muscle, tendon, ligament or proteoglycan-rich matrix formation is desired.

2. The method of claim 1, wherein the concentrated population of cells that comprises adipose-derived stem cells further comprises progenitor cells.

3. The method of claim 1, wherein the concentrated population of cells that comprises adipose-derived stem cells is suitable for infusion into a patient.

4. The method of claim 1, wherein said site is an intervertebral disc.

5. The method of claim 4, wherein said concentrated population of cells that comprises adipose-derived stem cells is introduced by direct injection into the intervertebral disc.

6. The method of claim 3, wherein said concentrated population of cells that comprises adipose-derived stem cells is introduced by injection into a gel that is placed within said subject.

7. The method of claim 1, wherein said concentrated population of cells that comprises adipose-derived stem cells is introduced into a subject in need of an intervertebral body spinal fusion.

8. The method of claim 1, wherein said concentrated population of cells that comprises adipose-derived stem cells are introduced into a subject in need of an intertransverse process spinal fusion.

9. The method of claim 1, wherein said concentrated population of cells that comprises adipose-derived stem cells is introduced into a subject in need of cartilage formation.

10. The method of claim 9, wherein said concentrated population of cells that comprises adipose-derived stem cells is introduced into a subject in need of cartilage formation at the end of long bones.

11. The method of claim 9, wherein said concentrated population of cells that comprises adipose-derived stem cells is introduced into a subject in need of cartilage formation in a knee joint.

12. The method of claim 9, wherein said concentrated population of cells that comprises adipose-derived stem cells is introduced into a subject in need of cartilage formation in the ribs.

13. The method of claim 9, wherein said concentrated population of cells that comprises adipose-derived stem cells is introduced by direct injection into the site of cartilage formation.

14. The method of claim 9, wherein said concentrated population of cells that comprises adipose-derived stem cells is introduced by injection into a gel that is placed within said subject.

15. The method of claim 1, wherein said concentrated population of cells that comprises adipose-derived stem cells is introduced into a subject in need of repair of a long bone fracture.

16. The method of claim 1, wherein said concentrated population of cells that comprises adipose-derived stem cells is introduced into a subject in need of bone or cartilage formation.

17. The method of claim 1, wherein said concentrated population of cells that comprises adipose-derived stem cells is introduced into a subject in need of tendon repair.

18. The method of claim 17, wherein the tendon is at a tendon-bone insertion site.

19. The method of claim 1, wherein said concentrated population of cells that comprises adipose-derived stem cells is introduced into a subject in need of skeletal muscle formation.

20. The method of claim 1, wherein said concentrated population of cells that comprises adipose-derived stem cells is introduced into a subject in need of ligament repair.

21. The method of claim 21, wherein said concentrated population of cells that comprises adipose-derived stem cells is introduced into a subject in need of ligament repair at a ligament-muscle insertion site.

22. The method of claim 21, wherein said concentrated population of cells that comprises adipose-derived stem cells is introduced into a subject in need ligament repair at a ligament-bone insertion site.

23. The method of claim 1, wherein one or more additives are added to the concentrated population of cells that comprises adipose-derived stem cells.

24. The method of claim 23, wherein the one or more additives are growth factors, re-suspension fluids, cell culture reagents, cell expansion reagents, cell preservation reagents cell modification reagents, cells, tissue, or tissue fragments or combinations thereof.

25. The method of claim 1, wherein said concentrated population of cells that comprises adipose-derived stem cells is grown in cell culture.

26. The method of claim 1, wherein said concentrated population of cells that comprises adipose-derived stem cells are not grown in cell culture.

27. The method of claim 25, wherein said concentrated population of cells that comprises adipose-derived stem cells is grown in culture conditions that promotes differentiation towards an osteogenic phenotype.

28. The method of claim 1, wherein the concentrated population of cells that comprises adipose-derived stem cells is placed on a surgical device or implant.

29. The method of claim 28, wherein the surgical device is a spinal fusion device.

30. The method of claim 28, wherein the surgical implant is a scaffold.

31. The method of claim 30, wherein the scaffold is porous.

32. The method of claim 1, wherein the concentrated population of cells that comprises adipose-derived stem cells are placed in a gel.

33. A method for promoting bone, cartilage, skeletal muscle, tendon, ligament or proteoglycan-rich matrix formation in a subject comprising:

identifying a subject with a musculoskeletal disorder;

obtaining a unit of adipose tissue from said subject;

processing said adipose tissue obtained from said subject to obtain a uncultured concentrated population of cells that comprises adipose-derived stem cells;

mixing said uncultured concentrated population of cells that comprises adipose-derived stem cells in a hydrogel liquid; and

introducing the mixture of the uncultured concentrated population of cells that comprises adipose-derived stem cells into said subject by injection at a site where bone, cartilage, skeletal muscle, tendon, ligament or proteoglycan-rich matrix formation is desired.