A Study of MACI in Patients Aged 17 to 65 Years With Symptomatic Chondral or Osteochondral Defect… (NCT06915233) | Clinical Trial Compass
RecruitingPhase 3
A Study of MACI in Patients Aged 17 to 65 Years With Symptomatic Chondral or Osteochondral Defects of the Ankle
United States309 participantsStarted 2026-03
Plain-language 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.
Who can participate
Age range17 Years – 65 Years
SexALL
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Inclusion criteria
✓. 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.
✓. Written informed consent and assent (as applicable) per Institutional Review Board (IRB) requirements.
✓. Subject will refrain from using Non-steroidal Anti-inflammatory Drugs (NSAIDS) for 12 weeks post-study treatment. (Post-surgical use of low-dose aspirin for clot prevention is acceptable).
✓. Subject will restrict pain medication to over-the-counter analgesics (NSAIDs or acetaminophen/paracetamol) after 12 weeks post-study treatment.
✓. Subject must have Hematocrit ≥30.0%; White Blood Cell count ≤14,000 cells/μL; Platelet Count ≥50,000 platelets/μL; Creatinine ≤2.0 mg/dL; and International Normalized Ratio (INR) ≤1.6.
Exclusion criteria
✕. 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).
What they're measuring
1
Change from Baseline to Week 104 in the FAOS Pain and Function (SRA) subscale scores
. Previous investigational drug, biologic or device use within 12 weeks prior to Visit.
✕. Avascular necrosis of the target ankle.
✕. Symptomatic musculoskeletal conditions in the lower limbs that could impede measurement of efficacy for the target ankle joint.
✕. Subjects with "kissing lesions" (bipolar lesions, involving both the tibia and talus), or with bilateral lesions in both ankles.
✕. Subjects with lesions that require an osteotomy procedure to allow for MACI implantation as determined at the time of ankle arthroscopy (Visit 2).
✕. Concomitant systemic inflammatory diseases or other conditions that affect the joints (e.g., rheumatoid arthritis, metabolic bone disease, psoriasis, symptomatic chondrocalcinosis).