Phase 2 Study to Assess Safety and Effectiveness of CartiLife4 Pellets for Knee Cartilage Defects Caused by Injury or Wear

What this Trial Is About

The trial investigates the use of pellet-type extracellular matrix-associated autologous chondrocytes called CartiLife4 for adults with articular cartilage defects in the knee caused by trauma or degeneration. This open-label, phase 2 study aims to assess the safety and effectiveness of CartiLife4 by observing structural cartilage regeneration and improvements in knee function and pain over 48 weeks. CartiLife4 is made of small beads derived from a patients own costal chondrocytes, cultured and formed into pellets. These pellets are implanted into the knee cartilage defect using a minimal arthrotomy with fibrin adhesive to hold them in place. The dose depends on the size of the cartilage defect, with one pre-filled syringe implanted per cubic centimeter of defect volume. Participants will be evaluated before and up to 48 weeks after implantation using various assessments such as the Knee Injury and Osteoarthritis Outcome Score KOOS, Lysholm Score, IKDC Score, pain scales, and imaging techniques like MOCART and T2 mapping. Safety will be monitored for up to 24 months post-operation, including tracking any treatment-related adverse events and changes in pain medication use. Participants must follow a rehabilitation and follow-up program during the study.

Phase 2 Clinical Trial of CartiLife® in the United States