A Phase 3 Study Comparing MACI and Bone Marrow Stimulation for Treating Symptomatic Cartilage Defects of the Ankle in Adults Aged 17 to 65

What this Trial Is About

Researchers are evaluating the effectiveness of MACI, which uses autologous cultured chondrocytes on a porcine collagen membrane, compared with Bone Marrow Stimulation BMS in treating adults aged 17 to 65 with painful cartilage or bone defects in the ankle. This Phase 3, open-label, randomized trial aims to show whether MACI is superior to BMS for symptomatic chondral or osteochondral lesions of the talus. Participants will be randomized 21 to receive either a single treatment of MACI or BMS. Initially, all participants will have an ankle arthroscopy to confirm eligibility and measure cartilage lesions. Those assigned to BMS will undergo the procedure during this arthroscopy. Those assigned to MACI will have a cartilage biopsy taken for cell culture, followed by a separate MACI implantation surgery within 5 to 12 weeks. Both groups will follow a recommended rehabilitation program after their procedures. Participants will be monitored for safety and effectiveness at multiple visits up to two years after treatment, including assessments at Weeks 6, 12, 24, 36, 52, 78, and 104. Measures include pain and function scores using the Foot and Ankle Outcome Score FAOS subscales, with rehabilitation status tracked through Week 52. Safety evaluations will continue throughout the study to assess the outcomes of both treatments.

A Study of MACI in Patients Aged 17 to 65 Years With Symptomatic Chondral or Osteochondral Defects of the Ankle