A Prospective, Open-label, Randomized, Concurrent Active-controlled, Longitudinal, Multicenter, Phase 3 Clinical Study of the Safety and Efficacy of MACI in Patients Aged 10 to 17 Years With Symptomatic Chondral or Osteochondral Defects of the Knee
Vericel Corporation
Summary
The objective of this study is to compare the efficacy and safety of MACI® vs arthroscopic microfracture in the treatment of patients aged 10 to 17 years with symptomatic articular chondral or osteochondral defects of the knee.
Description
This is a 2-year prospective, multicenter, randomized, open-label, parallel group clinical trial; a total of 45 patients, ages 10 to 17 years, will be randomized to receive a 1-time treatment with MACI or microfracture (2:1, 30 MACI:15 microfracture). After meeting screening criteria at the initial visit, all patients will have a screening arthroscopy to further assess study eligibility. During the screening arthroscopy, patients will be further evaluated against entry criteria. Cartilage lesion size will be measured prior to any cartilage repair procedure and randomization. All patients who…
Eligibility
- Age range
- 10–17 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Symptomatic cartilage or osteochondral defects * One or more International Cartilage Repair Society (ICRS) Grade III or IV chondral or unsalvageable osteochondral defects located on the femoral condyles and/or trochlea amenable to treatment with the surgical procedure determined at randomization (MACI or microfracture). * At least 1 defect size ≥1.5 cm2 on the femoral condyles and/or the trochlea; defects include OCD lesions with a bone lesion depth of ≤6 mm and does not require a bone graft. * Stable target knee (i.e., anterior and posterior cruciate ligaments should be…
Interventions
- BiologicalMACI
autologous cultured chondrocytes on porcine collagen membrane
- Proceduremicrofracture
Arthroscopic microfracture treatment
Locations (12)
- Stanford UniversityPalo Alto, California
- Shriner's Hospital for Children Northern CaliforniaSacramento, California
- University of California Davis HealthSacramento, California
- Ochsner Sports Medicine InstituteNew Orleans, Louisiana
- Johns Hopkins Outpatient CenterBaltimore, Maryland
- University of MichiganAnn Arbor, Michigan