Clinical Trials
A Study of MACI in Patients Aged 10 to 17 Years With Symptomatic Chondral or Osteochondral Defects of the Knee
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.
Stanford is currently accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- biological: MACI
- procedure: microfracture
Eligibility
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Ages Eligible for Study
10 Years - 17 Years
Genders Eligible for Study
All
Now accepting new patients
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Recruiting
Please see a full listing of Stanford's clinical trials here.
Use the ClinicalTrials.gov directory to search among all government-funded clinical trials.