Status:
RECRUITING
A Study of MACI in Patients Aged 10 to 17 Years With Symptomatic Chondral or Osteochondral Defects of the Knee
Lead Sponsor:
Vericel Corporation
Conditions:
Chondral Defect
Osteochondritis Dissecans (OCD)
Eligibility:
All Genders
10-17 years
Phase:
PHASE3
Brief 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 osteoch...
Detailed 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 MAC...
Eligibility Criteria
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 free of laxity as well as stable and intact). Ligament repair or reconstruction procedures are allowed prior to screening arthroscopy.
- Intact meniscus or partial meniscus (at least 50% of functional meniscus remaining) in the target knee.
Exclusion Criteria:
- Any surgery on the target knee joint within 6 months prior to Screening (not including diagnostic arthroscopy)
- ICRS Grade III or IV chondral or unsalvageable osteochondral defects located on the patella or tibia or any lesion that is bipolar to the index lesion
- Concomitant inflammatory disease or other conditions that affects the joints (eg, rheumatoid arthritis, metabolic bone disease, psoriasis, symptomatic chondrocalcinosis)
- Known history of septic arthritis in the index knee joint
- Known history of hypersensitivity to gentamicin, other aminoglycosides, or products of porcine or bovine origin
- Females who are pregnant or lactating
Key Trial Info
Start Date :
October 24 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2027
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT03588975
Start Date
October 24 2018
End Date
June 1 2027
Last Update
December 2 2024
Active Locations (12)
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1
Stanford University
Palo Alto, California, United States, 94304
2
Shriner's Hospital for Children Northern California
Sacramento, California, United States, 95817
3
University of California Davis Health
Sacramento, California, United States, 95817
4
Ochsner Sports Medicine Institute
New Orleans, Louisiana, United States, 70121