Phase III Study to Test Safety and Effectiveness of CLS2901C Cell Sheets with Osteotomy in Knee Osteoarthritis Patients Aged 20 to 79

What this Trial Is About

Researchers are evaluating the effectiveness and safety of CLS2901C human allogenic chondrocyte sheets combined with proximal tibial osteotomy compared to osteotomy alone in patients with osteoarthritis of the knee OAK. This phase III study focuses on patients aged 20 to 79 years diagnosed with OAK, classified by specific X-ray criteria. The purpose is to understand how this new cellular therapy may impact knee function and symptoms over time. The study involves two groups one receiving osteotomy surgery alone and the other receiving osteotomy combined with CLS2901C chondrocyte sheets applied to the knee. The chondrocyte sheets are made by culturing cartilage cells derived from patients with polydactyly. The evaluation period for each group lasts about 14.5 months, including 52 weeks of active assessment followed by up to 5 years of additional observation for those available to continue. Participants will undergo various assessments including knee function measured by the KOOS 4 score over 52 weeks. Safety is monitored through adverse event rates and product malfunctions. Researchers will also continue to observe patients for up to 5 years after receiving the chondrocyte sheets to evaluate long-term effects. The overall study duration spans from initial treatment through extended follow-up to fully understand treatment outcomes and safety.

A Phase III Study of CLS2901C in Patients With Osteoarthritis of the Knee