Skip to main content
Skip to main content
Go to homepage

Safety and efficacy of MACI® in patients 10-17 years

A Study of MACI® in Patients Aged 10 to 17 Years with Symptomatic Chondral or Osteochondral Defects of the Knee (PEAK)

Description:

For complete study information, please visit the study page on clinicaltrials.gov

Who May Qualify?:

Children aged 10-17 with:

  • Symptomatic cartilage or osteochondral defects as a result of acute trauma or Osteochondritis Dissecans (OCD)
  • 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 ≥2.0 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 (ie, 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.
Who Does Not Qualify:
  • Patients over 17 years
  • 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
Interested in participating?
We are currently recruiting
Study Sponsor:

Vericel Corporation

Full IRB Study Title:
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 due to osteochondritis dissecans or acute trauma (short name: PEAK Clinical Trial)
IRB Study ID:
1694961
If you are interested in this study or have questions about your child's eligibility, please contact:

Melanie Morscher, Study Coordinator

330-543-8935

Lead Investigator
John Polousky, MD

Division Director, Orthopedic Sports Medicine
Orthopedics