Intra-articular Injection of UC-MSC Exosome in Knee Osteoarthritis

This early Phase 1 study is evaluating whether a single injection of tiny particles called small extracellular vesicles (sEVs), derived from umbilical cord stem cells, is safe when injected directly into the knee joint of patients with mild-to-moderate osteoarthritis. The goal is to test three increasing dose levels across groups of four patients each to find any safety signals and determine the best dose for future studies. Adults aged 30 to 70 with confirmed knee osteoarthritis, knee pain of at least 40mm on a visual scale, and no need for surgery are eligible; those with obesity (BMI over 30), joint instability, or recent steroid injections are excluded. Participants will receive a single joint injection and will be monitored closely for adverse effects, pain, and joint swelling at multiple follow-up appointments over 12 months. This summary was prepared to help patients understand the study in plain language.