Actively Recruiting
A Study of MACI in Patients Aged 10 to 17 Years With Symptomatic Chondral or Osteochondral Defects of the Knee
Led by Vericel Corporation · Updated on 2024-12-02
45
Participants Needed
12
Research Sites
448 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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...
- Symptomatic cartilage or osteochondral defects
- One or more International Cartilage Repair Society (ICRS) Grade III or IV chondral or unsalvageable osteochondral defects on femoral condyles and/or trochlea treatable by MACI or microfracture
- At least one defect sized 1.5 cm2 or larger on femoral condyles and/or trochlea; includes OCD lesions with bone lesion depth up to 6 mm without need for bone graft
- Stable target knee with intact or repaired anterior and posterior cruciate ligaments
- Intact meniscus or partial meniscus with at least 50% functional meniscus remaining in target knee
You will not qualify if you...
- Surgery on target knee joint within 6 months prior to screening (excluding diagnostic arthroscopy)
- ICRS Grade III or IV chondral or unsalvageable osteochondral defects located on patella or tibia or any lesion bipolar to the index lesion
- Concomitant inflammatory diseases or other joint-affecting conditions (e.g., rheumatoid arthritis, metabolic bone disease, psoriasis, symptomatic chondrocalcinosis)
- Known history of septic arthritis in the index knee joint
- Known hypersensitivity to gentamicin, other aminoglycosides, or porcine/bovine products
- Female patients who are pregnant or breastfeeding
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
K
Kristin M Tripp, BS
CONTACT
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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