A Phase 3 Study Comparing MACI and Microfracture Treatments for Knee Cartilage Defects in Patients Aged 10 to 17 Years

What this Trial Is About

Researchers are evaluating the safety and effectiveness of MACI compared to arthroscopic microfracture surgery in treating young participants aged 10 to 17 years who have symptomatic cartilage or bone-related defects in the knee. This Phase 3 clinical trial involves 45 participants who are randomly assigned to receive one of these two treatments. The study explores which approach might better improve knee pain and function over time. Participants undergo an initial screening visit including an arthroscopy to confirm eligibility. During this procedure, cartilage lesion size is measured, and a biopsy is taken for cell processing. Those assigned to MACI will receive a one-time implantation of cultured cartilage cells on a collagen membrane within 12 weeks following screening. Those assigned to microfracture undergo the procedure during the initial arthroscopy. Participants follow a recommended rehabilitation plan after treatment. Participant involvement spans two years after treatment, during which researchers monitor recovery and knee function. Assessments include measuring improvements in pain and sports-related activities using the KOOS-Child questionnaire at baseline and at 52 and 104 weeks. Compliance with rehabilitation and long-term safety are also tracked, ensuring thorough evaluation of treatment outcomes.

A Study of MACI in Patients Aged 10 to 17 Years With Symptomatic Chondral or Osteochondral Defects of the Knee