A Study of MACI in Patients Aged 17 to 65 Years With Symptomatic Chondral or Osteochondral Defects of the Ankle
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age17-65
SponsorVericel Corporation
About this trial
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.
Eligibility criteria
Qualifiers
Age 17 to 65 at the time of planned randomization visit (Visit 2).
One or more symptomatic chondral or osteochondral lesion/s as defined by FAOS Pain score ≤ 50 and FAOS Function (SRA) score ≤ 50.
International Cartilage Repair Society (ICRS) Score Grade 3 or 4 chondral or osteochondral lesion/s located on the talus with or without cysts, including shoulder lesions (lesions on the talar neck), and amenable to treatment with the surgical procedure specified at randomization.
At least 1 lesion ≥ 1.2 cm².
Disqualifiers
Lesions with an underlying bony defect depth of > 5 mm.
Any surgery on the target joint within 24 weeks prior to Visit 1 (not including diagnostic ankle arthroscopy).
Previous investigational drug, biologic or device use within 12 weeks prior to Visit.
Avascular necrosis of the target ankle.
Trial design
Treatments tested in this trial
- autologous cultured chondrocytes on porcine collagen membrane
- Bone Marrow Stimulation
Treatment groups
309 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov