Methods of using adipose-derived regenerative cells in the treatment of peripheral vascular disease and related disorders
View Patent ↗Cells present in adipose tissue are used to treat patients, including patients with PVD and related diseases or disorders. Methods of treating patients include processing adipose tissue to deliver a concentrated amount of stem 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, cells present in adipose tissue are placed directly into a recipient along with such additives necessary to promote, engender or support a therapeutic benefit.
1. A method for treating peripheral vascular disease (PVD) in a subject, comprising:
identifying a subject with PVD;
obtaining a unit of adipose tissue from said subject;
processing said adipose tissue by separating adipose-derived cells comprising stem and progenitor cells from mature adipocytes and connective tissue, and washing, separating, and concentrating said adipose-derived cells from adipose tissue to obtain a concentrated population of cells comprising adipose-derived stem and endothelial progenitor cells, wherein at least 0.1% of the adipose-derived cells are adipose-derived stem cells; and
providing to the subject an amount of said concentrated population of adipose-derived cells that is sufficient to restore blood flow to an ischemic region, wherein said concentrated population of adipose-derived cells is not grown in culture.
2. The method of claim 1 , further comprising providing an additive to said concentrated population of adipose-derived cells.
3. The method of claim 1 , wherein said subject is human.
4. The method of claim 1 , wherein said subject suffers from a defect or disorder of a blood vessel.
5. The method of claim 1 , wherein said subject suffers from Peripheral Artery Disease (PAD).
6. The method of claim 1 , wherein said subject suffers from at least one disease or disorder selected from the group consisting of arteriosclerosis, traumatic injury of vessels and inflammatory arteritides.
7. The method of claim 1 , wherein said subject suffers from a defect or disorder of extracoronary tissue of the subject.
8. The method of claim 1 , wherein said concentrated population of adipose-derived cells is provided to said subject in multiple doses.
9. The method of claim 1 , further comprising providing one or more angiogenic factors to said subject or to said concentrated population of adipose-derived cells.
10. The method of claim 1 , further comprising providing one or more immunosuppressive drugs to said subject or to said concentrated population of adipose-derived cells.
11. The method of claim 1 , wherein said concentrated population of adipose-derived cells is provided to said subject via at least one of an intravenous, intra-muscular or subcutaneous administration route.
12. The method of claim 1 , wherein the concentrated population of adipose-derived cells is provided to the subject's vasculature.
13. The method of claim 1 , wherein the concentrated population of adipose-derived cells is provided on a scaffold.
14. The method of claim 13 , wherein the scaffold is resorbable in vivo.
15. The method of claim 1 , wherein said adipose tissue is processed in a system configured to maintain a closed, sterile, fluid/tissue pathway, wherein said system comprises a collection chamber connected to a processing chamber.
16. The method of claim 1 , wherein said processed in a system configured to maintain a closed, sterile, fluid/tissue pathway, wherein said system comprises a filter and a centrifuge.
17. The method of claim 1 , wherein said processing comprises digesting said adipose tissue to create a digestate and removing mature adipocytes from said digestate.
18. The method of claim 1 , further comprising measuring blood flow by a method selected from the group consisting of: duplex ultrasonography, angiography, and magnetic resonance angiography.
19. The method of claim 1 , further comprising assessing a clinical outcome selected from the group consisting of: improved blood flow, reduction in claudication, healing of ischemic ulceration, increased oxygen content of tissue, and improvement in ankle-brachial index (ABI), or any combination thereof.
20. The method of claim 1 , wherein said adipose tissue is processed in a system configured to maintain a closed, sterile, fluid/tissue pathway, wherein said system comprises:
a tissue collection chamber that is configured to receive unprocessed adipose tissue that is removed from a subject, wherein said tissue collection chamber is defined by a closed system;
a first filter that is disposed within said tissue collection chamber, wherein said first filter is configured to retain a first component of said unprocessed adipose tissue and pass a second component of said unprocessed adipose tissue, such that said first filter substantially separates said first component from said second component, and wherein said first component comprises a cell population that comprises adipose-derived stem cells and endothelial progenitor cells, and said second component comprises lipid, mature adipocytes, and saline;
a processing chamber, which is configured to receive said first component comprising said cell population that comprises adipose-derived stem cells and endothelial progenitor cells from said tissue collection chamber, wherein said processing chamber is within said closed system;
a conduit configured to allow passage of said first component comprising said cell population comprising adipose-derived stem cells and endothelial progenitor cells from said tissue collection chamber to said processing chamber while maintaining a closed system;
a cell concentrator disposed within said processing chamber, which is configured to facilitate the concentration of said first component comprising said cell population that comprises adipose-derived stem cells and endothelial progenitor cells so as to obtain a concentrated population of adipose-derived cells, wherein said cell concentrator comprises a centrifugation device or a filter; and
an outlet configured to allow the aseptic removal of said concentrated population of adipose-derived cells.
21. The method of claim 1 , wherein said concentrated population of adipose-derived cells is cryopreserved.