Safety and Effectiveness of Autologous Regenerative Cell Therapy for Pain and Inflammation in Shoulder Osteoarthritis

What this Trial Is About

Researchers are evaluating autologous cell therapy as a potential treatment for pain and inflammation caused by Osteoarthritis of the shoulder. This open-label study aims to assess the safety and treatment potential of this approach in 50 patients, with plans for a larger follow-up study involving 4,000 patients. The study is sponsored by VivaTech International, Inc. and focuses on patients with shoulder osteoarthritis due to degeneration or chronic injury. Participants will receive autologous StroMed cells obtained using the Adipose Ultrasonic Cell Recovery Unit and Platelet Rich Plasma PRP processed by the RegenLab RegenKit BCT-3. These treatments are given as direct injections into the affected shoulder joints, with an initial combined injection of StroMed and PRP on day 0, followed by PRP injections on days 7 and 14. The StroMed cells are mechanically processed without enzymes or drugs, maintaining the extracellular matrix and minimizing risk to patients. Throughout the study, participants will undergo laboratory tests to track inflammation markers and complete several questionnaires including the DASH, SPADI, SF-36 quality of life, and Numerical Rating Scale for pain at 0, 2, and 6 months. MRI scans of the affected joint will be performed at baseline and optionally at 6 months to assess changes. Researchers will monitor safety, treatment effects, medication use, and any delay in shoulder replacement plans over a six-month period.

Safety & Effectiveness of Autologous Regenerative Cell Therapy on Pain & Inflammation of Osteoarthritis of the Shoulder