Pilot Study on Safety and Feasibility of Umbilical Cord Whartons Jelly Injections for Knee Osteoarthritis Randomized Dose Escalation Trial with Low, Medium, and High Dose Treatments

What this Trial Is About

Researchers are evaluating the safety and feasibility of injecting Whartons Jelly WJ allograft directly into the knee joint of patients with knee osteoarthritis OA. This pilot study is randomized, prospective, and open-label, focusing on dose escalation without a control group. It includes patients aged 30 and older with moderate knee OA. The study aims to observe safety and possible improvements in pain and function over one year. Participants will be randomly assigned to receive one of three doses of WJ allograft in a single knee injection 2cc low dose, 3cc medium dose, or 4cc high dose. A total of 120 patients will be evenly divided among these three groups. No placebo or control group is included since the primary goal is to assess safety. The treatment is administered as a direct injection into the affected knee joint. Throughout the study, participants will undergo various assessments including blood tests measuring inflammation and organ function at baseline, 1 week, 6 weeks, 3 months, 6 months, and 1 year after treatment. They will also complete pain and functional questionnaires at regular intervals to track changes. The study includes imaging and laboratory evaluations to monitor safety, pain relief, and functional improvements during the one-year follow-up period.

Safety and Feasibility of Umbilical Cord Wharton's Jelly Allograft Injections for Knee Osteoarthritis