Study of Autologous Cell Therapy Using StroMed and Platelet Rich Plasma for Knee Osteoarthritis Pain and Inflammation

What this Trial Is About

Researchers are evaluating the safety and potential treatment effects of autologous cell therapy for pain and inflammation caused by osteoarthritis of the knee. This prospective open-label clinical trial initially includes 50 patients, with plans for a larger follow-up study involving 4,000 participants. The trial focuses on patients suffering from knee osteoarthritis due to degeneration or chronic injury. Participants will receive autologous Stromed cells obtained through a mechanical process without enzymes or drugs, combined with Platelet Rich Plasma PRP processed by RegenLab. The treatment involves direct injections into the affected knee joints. Patients are divided into two groups Cohort 1 receives PRP injections at the time of initial StroMed treatment and then at 1 week, 2 weeks, and 1 month Cohort 2 receives PRP at the initial treatment and then at 1 month and 2 months. During the study, patient outcomes will be monitored through MRI scans at various points up to 6 months, blood tests for inflammation markers, and questionnaires including the Knee Osteoarthritis Outcome Score KOOS, the SF-36 quality of life survey, and numerical rating scales for pain. Researchers will also observe any reduction in medication use or delay in knee replacement surgery. The trial runs from July 2015 to August 2026 and includes regular follow-ups to assess safety and effectiveness.

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