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


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