A Prospective, Double Blind, Multi-Center Pivotal Trial of Autologous Adult Adipose-Derived Regenerative Cell Injection into Chronic Partial-Thickness Rotator Cuff Tears
The purpose of this study is to investigate the safety and effectiveness of autologous (from the same person) regenerative cells and the investigational device used to process an investigational cell product used in patients with chronic partial-thickness rotator cuff tears compared with the standard of care steroid treatment.
Regenerative cells are a mixture of cells that include stem cells. Stem cells are unspecialized cells that have great adaptability, each stem cells divides into new cells that can become another cell type with specialized function, such as a muscle. One of roles of these regenerative cells is to regenerate and repair tissues such as tendons. This study uses a procedure that takes regenerative cells from fat tissue in your abdomen and concentrates them for injection into the rotator cuff.