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
Who is this study for? Patients aged 10 to 17 years with symptomatic chondral or osteochondral defects of the knee due to osteochondritis dissecans or acute trauma
Status: Recruiting
Location: See all (12) locations...
Intervention Type: Procedure, Biological
Study Type: Interventional
Study Phase: Phase 3
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 10
Maximum Age: 17
Healthy Volunteers: f
View:
• 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.
Locations
United States
California
Stanford University
RECRUITING
Palo Alto
Shriner's Hospital for Children Northern California
RECRUITING
Sacramento
University of California Davis Health
RECRUITING
Sacramento
Louisiana
Ochsner Sports Medicine Institute
RECRUITING
New Orleans
Maryland
Johns Hopkins Outpatient Center
RECRUITING
Baltimore
Michigan
University of Michigan
RECRUITING
Ann Arbor
Ohio
Akron Children's Hospital
RECRUITING
Akron
The Ohio State University Jameson Crane Sports Medicine Institute
RECRUITING
Columbus
Pennsylvania
Children's Hospital of Philadelphia
RECRUITING
Philadelphia
Penn Sports Medicine Center
RECRUITING
Philadelphia
Texas
Texas Children's Hospital
WITHDRAWN
Houston
Wisconsin
Medical College of Wisconsin
RECRUITING
Milwaukee
Contact Information
Primary
Mikhail Chkolnik, MD
mchkolnik@vcel.com
484-387-2257
Backup
Kristin M Tripp, BS
ktripp@vcel.com
Time Frame
Start Date:2018-10-24
Estimated Completion Date:2027-06
Participants
Target number of participants:45
Treatments
Experimental: MACI
autologous cultured chondrocytes on porcine collagen membrane