A Study of MACI in Patients Aged 10 to 17 Years With Symptomatic Chondral or Osteochondral Defects of the Knee
PEAK
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
1 other identifier
interventional
45
1 country
12
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 osteochondral defects of the knee.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Oct 2018
Longer than P75 for phase_3
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 4, 2018
CompletedFirst Posted
Study publicly available on registry
July 17, 2018
CompletedStudy Start
First participant enrolled
October 24, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2027
December 2, 2024
November 1, 2024
8.6 years
April 4, 2018
November 26, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Proportion of Patients Who Achieve at Least a 10-point Improvement From Baseline in KOOS-Child Pain and Function (Sports and Recreational Activities) Scores
A responder is defined as a participant with at least a 10-point change (improvement) in both the KOOS-Child Pain and Function (Sports and Recreational activities) scores from Baseline scores. The Knee and Osteoarthritis Outcome Score for Children (KOOS-Child) is a validated knee-specific instrument developed to assess the patients' opinion of their knee and associated problems. KOOS consists of 5 subscales: Pain, Function in sports and recreational activities, other Symptoms, Function in activities of daily living (ADL), and knee related Quality of life (QOL).
Baseline and Week 104
Secondary Outcomes (2)
Change from Baseline in KOOS-Child subscores
Baseline and Week 104
Change from Baseline in KOOS-Child subscores
Baseline and Week 52
Other Outcomes (1)
Treatment Emergent Adverse Events
Week 104
Study Arms (2)
MACI
EXPERIMENTALautologous cultured chondrocytes on porcine collagen membrane
microfracture
ACTIVE COMPARATORsurgical procedure
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (12)
Stanford University
Palo Alto, California, 94304, United States
Shriner's Hospital for Children Northern California
Sacramento, California, 95817, United States
University of California Davis Health
Sacramento, California, 95817, United States
Ochsner Sports Medicine Institute
New Orleans, Louisiana, 70121, United States
Johns Hopkins Outpatient Center
Baltimore, Maryland, 21224, United States
University of Michigan
Ann Arbor, Michigan, 48106, United States
Akron Children's Hospital
Akron, Ohio, 44308, United States
The Ohio State University Jameson Crane Sports Medicine Institute
Columbus, Ohio, 43202, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104, United States
Penn Sports Medicine Center
Philadelphia, Pennsylvania, 19104, United States
Texas Children's Hospital
Houston, Texas, 77094, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53201, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Jonathan Hopper
Vericel Corporation
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 4, 2018
First Posted
July 17, 2018
Study Start
October 24, 2018
Primary Completion (Estimated)
June 1, 2027
Study Completion (Estimated)
June 1, 2027
Last Updated
December 2, 2024
Record last verified: 2024-11
Data Sharing
- IPD Sharing
- Will not share