Actively Recruiting
A Prospective, Open-label, Randomized, Controlled Phase 3 Study of MACI in Patients 10 to 17 Years With Symptomatic Knee Chondral or Osteochondral Defects
Led by Vericel Corporation · Updated on 2024-12-02
45
Participants Needed
12
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness and safety of MACI compared to arthroscopic microfracture for treating young patients aged 10 to 17 years who have symptomatic cartilage or osteochondral defects in the knee. This phase 3 clinical trial seeks to understand which treatment better improves pain and function related to these knee defects. This study randomly assigns a total of 45 patients into two groups: 30 will receive a single treatment with MACI, which involves autologous cultured chondrocytes on a porcine collagen membrane, and 15 will receive arthroscopic microfracture treatment during a screening arthroscopy. Patients assigned to MACI return within 12 weeks for the cell implantation surgery and follow a recommended rehabilitation program. The trial lasts for two years after treatment to monitor outcomes. Participants undergo a screening arthroscopy to confirm eligibility and have a cartilage biopsy taken before treatment. Researchers will monitor cartilage lesion size, compliance with rehabilitation, and measure improvements in knee pain and function using KOOS-Child scores over 104 weeks. Safety and efficacy are tracked carefully throughout the study period.
CONDITIONS
Brief Title
A Study of MACI in Patients Aged 10 to 17 Years With Symptomatic Chondral or Osteochondral Defects of the Knee
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ages 10 to 17 years
- Symptomatic cartilage or osteochondral defects in the knee
- One or more ICRS Grade III or IV defects on femoral condyles and/or trochlea suitable for MACI or microfracture
- Defect size at least 1.5 cm2 on femoral condyles and/or trochlea; includes OCD lesions with bone depth up to 6 mm without need for bone graft
- Stable target knee with intact or at least 50% functional meniscus
- Ligaments stable and intact; prior ligament repair or reconstruction allowed before screening arthroscopy
You will not qualify if you...
- Surgery on target knee within 6 months before screening (excluding diagnostic arthroscopy)
- ICRS Grade III or IV defects on patella or tibia or bipolar lesions
- Inflammatory or other joint-affecting diseases (e.g., rheumatoid arthritis, metabolic bone disease, psoriasis, chondrocalcinosis)
- History of septic arthritis in the target knee
- Known allergy to gentamicin, aminoglycosides, or porcine/bovine products
- Females who are pregnant or breastfeeding
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) including screening arthroscopy
Duration - Up to 12 weeks from screening to MACI implantation or microfracture procedure
Participants receive a one-time surgical treatment with either MACI implant or microfracture procedure.
1 surgical visit for treatment; MACI participants return for implantation within 12 weeks of screening arthroscopy
Duration - 2 years (104 weeks)
Participants follow a recommended rehabilitation program and are monitored for recovery and treatment outcomes.
Regular follow-up visits over 2 years to assess recovery and outcomes
Trial Site Locations
Total: 12 locations
1
Stanford University
Palo Alto, California, United States, 94304
Actively Recruiting
2
Shriner's Hospital for Children Northern California
Sacramento, California, United States, 95817
Actively Recruiting
3
University of California Davis Health
Sacramento, California, United States, 95817
Actively Recruiting
4
Ochsner Sports Medicine Institute
New Orleans, Louisiana, United States, 70121
Actively Recruiting
5
Johns Hopkins Outpatient Center
Baltimore, Maryland, United States, 21224
Actively Recruiting
6
University of Michigan
Ann Arbor, Michigan, United States, 48106
Actively Recruiting
7
Akron Children's Hospital
Akron, Ohio, United States, 44308
Actively Recruiting
8
The Ohio State University Jameson Crane Sports Medicine Institute
Columbus, Ohio, United States, 43202
Actively Recruiting
9
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
10
Penn Sports Medicine Center
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
11
Texas Children's Hospital
Houston, Texas, United States, 77094
Withdrawn
12
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53201
Actively Recruiting
Research Team
M
Mikhail Chkolnik, MD
K
Kristin M Tripp, BS
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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