Safety and Effectiveness of Autologous Cell Therapy Using StroMed and Platelet Rich Plasma for Hip Osteoarthritis Pain and Inflammation

What this Trial Is About

Researchers are evaluating autologous cell therapy to study its safety and potential to treat pain and inflammation associated with Osteoarthritis of the hip. This prospective open-label study initially includes 50 patients, with a larger follow-up group planned involving 4,000 patients. The condition involves degeneration or chronic injury affecting the hip joint. Patients 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 will be injected directly into the affected hip joints. The treatment schedule includes an initial combined injection of StroMed and PRP on day 0, followed by PRP injections alone on days 7, 14, and 30. This approach uses a mechanical process without enzymes or drugs, aiming to minimize risks. Participants will be monitored through laboratory tests for inflammation markers, hip disability and osteoarthritis outcome score HOOS questionnaires, and follow-up MRIs up to 6 months. Additional assessments include SF-36 quality of life surveys and numerical rating scales for pain. Researchers will also observe any changes in medication use or delays in hip replacement surgery. The study measures changes in HOOS scores primarily at 0, 2, and 6 months.

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