A Prospective, Open-label, Randomized, Concurrent Active-controlled, Longitudinal, Multicenter, Phase 3 Clinical Study of the Safety and Efficacy of MACI in Patients With Symptomatic Chondral or Osteochondral Lesions of the Talus (MASCOT)
Vericel Corporation
Summary
The objective of this study is to demonstrate the superiority of MACI (autologous cultured chondrocytes on porcine collagen membrane) versus Bone Marrow Stimulation in the treatment of patients aged 17 to 65 years with symptomatic articular chondral or osteochondral defects of the talus.
Description
This is a 2-year prospective, multicenter, two-arm, parallel-group open-label clinical trial in which a total of 309 subjects, ages 17 to 65, will be randomized 2:1 to receive a 1-time treatment in the ankle with MACI or arthroscopic BMS. After meeting screening criteria at the initial visit (Visit 1), all participants will have an index ankle arthroscopy within 8 weeks to further assess clinical trial eligibility. During the index ankle arthroscopy (Visit 2), participants will be further evaluated against entry criteria. Cartilage lesion size will be measured before randomization and any car…