A Study of MACI in Patients Aged 10 to 17 Years With Symptomatic Chondral or Osteochondral Defects of the Knee
NCT ID: NCT03588975
Last Updated: 2024-12-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
45 participants
INTERVENTIONAL
2018-10-24
2027-06-30
Brief Summary
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Detailed Description
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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 meet the eligibility criteria and are considered suitable for treatment in the study will have a cartilage biopsy taken prior to randomization to study treatment. Eligible patients will be randomized during the screening arthroscopy procedure to receive either MACI or microfracture treatment. Patients randomized to microfracture will undergo the procedure during the screening arthroscopy.
All biopsied tissue will be sent to the Vericel manufacturing facility in Cambridge, Massachusetts, where the sample will be processed to isolate the autologous chondrocytes. Cells from patients randomized to the MACI group will be used in the preparation of the MACI implant; cells from patients randomized to the microfracture group will be cryopreserved.
Patients randomized to treatment with MACI will return within 12 weeks of the screening arthroscopy to undergo the chondrocyte implantation procedure via arthrotomy. Patients are to follow a recommended postoperative rehabilitation program and compliance with the rehabilitation schedule will be monitored.
Patients will be followed post-study treatment for 2 years (104 Weeks).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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MACI
autologous cultured chondrocytes on porcine collagen membrane
MACI
autologous cultured chondrocytes on porcine collagen membrane
microfracture
surgical procedure
microfracture
Arthroscopic microfracture treatment
Interventions
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MACI
autologous cultured chondrocytes on porcine collagen membrane
microfracture
Arthroscopic microfracture treatment
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
10 Years
17 Years
ALL
No
Sponsors
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Vericel Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Jonathan Hopper
Role: STUDY_DIRECTOR
Vericel Corporation
Locations
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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
Countries
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Central Contacts
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Related Links
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Vericel Clinical Trial for Cartilage Repair
Other Identifiers
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55-1702-1
Identifier Type: -
Identifier Source: org_study_id