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A Study of MACI in Patients Aged 10 to 17 Years With Symptomatic Chondral or Osteochondral Defects of the Knee
Sponsor: 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.
Official title: 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
Key Details
Gender
All
Age Range
10 Years - 17 Years
Study Type
INTERVENTIONAL
Enrollment
45
Start Date
2018-10-24
Completion Date
2027-06
Last Updated
2024-12-02
Healthy Volunteers
No
Conditions
Interventions
MACI
autologous cultured chondrocytes on porcine collagen membrane
microfracture
Arthroscopic microfracture treatment
Locations (12)
Stanford University
Palo Alto, California, United States
Shriner's Hospital for Children Northern California
Sacramento, California, United States
University of California Davis Health
Sacramento, California, United States
Ochsner Sports Medicine Institute
New Orleans, Louisiana, United States
Johns Hopkins Outpatient Center
Baltimore, Maryland, United States
University of Michigan
Ann Arbor, Michigan, United States
Akron Children's Hospital
Akron, Ohio, United States
The Ohio State University Jameson Crane Sports Medicine Institute
Columbus, Ohio, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Penn Sports Medicine Center
Philadelphia, Pennsylvania, United States
Texas Children's Hospital
Houston, Texas, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States