Phase 3 Clinical Trial Comparing CARTISTEM and Surgery for Treating Knee Cartilage Damage and Osteoarthritis

What this Trial Is About

Researchers are evaluating the effectiveness and safety of CARTISTEM, a combination of stem cells derived from human umbilical cord blood and a sodium hyaluronate gel, compared to a surgical procedure called debridement in people with knee cartilage lesions and osteoarthritis. The trial aims to show whether CARTISTEM can better reduce knee pain and improve knee function than debridement two years after treatment. It also explores if CARTISTEM might slow down the progression of osteoarthritis by using MRI scans. Participants are randomly assigned to one of two groups one group receives CARTISTEM along with debridement surgery on the affected knee, while the other group undergoes debridement surgery alone. CARTISTEM includes stem cells suspended in a gel that is applied during the procedure. The study follows participants for 24 months after treatment to assess results and safety. During the study, participants will have their knee pain and function measured using standard scales like the Visual Analog Scale VAS and WOMAC function score. MRI scans will be used to observe cartilage repair and osteoarthritis changes. Participants will be monitored regularly throughout the two-year follow-up period to track outcomes and any side effects. This trial lasts from enrollment through 24 months post-treatment, providing comprehensive evaluations over time.

Phase 3 Pivotal Trial Comparing CARTISTEM® and Surgical Comparator for Knee Cartilage Lesions and Osteoarthritis