Phase 3 Study of a Single Injection of PTP-001 Compared to Placebo for Treating Knee Osteoarthritis in Adults Aged 40 to 80

What this Trial Is About

Researchers are evaluating the use of PTP-001 MOTYS, an allogeneic human placental tissue particulate, for treating knee osteoarthritis OA. This Phase 3, multicenter, randomized, double-blind, placebo-controlled trial aims to assess the safety, tolerability, and effectiveness of a single injection of PTP-001 compared to placebo over a 52-week period in adults aged 40 to 80 with symptomatic and radiographically confirmed knee OA. Participants will be randomly assigned to receive one injection into the target knee of either 200 mg PTP-001 or 4 mL of placebo saline solution. The study includes a screening period lasting up to 28 days before treatment, a one-day treatment phase when the injection occurs, and a follow-up phase of 12 months to monitor outcomes and safety. Approximately 260 participants will be enrolled, with 130 in each treatment group. During the study, participants will undergo assessments at multiple time points, including evaluations of knee pain and function using standardized scales such as WOMAC and patient global assessments. The main outcomes focus on the proportion of participants showing strict improvement in knee pain and function at 6 months, with additional measurements at 9 and 12 months. Safety and tolerability will also be monitored throughout the follow-up period.

A Study to Evaluate the Efficacy and Safey of PTP-001 (MOTYS™) in Knee Osteoarthritis Patients