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MACI for Knee Cartilage Defects in Young People

This study is comparing two treatments for knee cartilage damage (chondral or osteochondral defects) in young people aged 10 to 17. It's testing MACI (autologous cultured chondrocytes on porcine collagen membrane) against a standard procedure called microfracture. Researchers want to see if MACI is more effective and safer. You could be eligible if you have symptomatic cartilage damage in your knee that is Grade III or IV. The study will consider the treatment successful if participants show a significant improvement in knee pain and function after two years. The current status of this study is unclear.

Study design
This is a 2-year, multicenter, randomized, open-label study involving 45 participants. Participants will be randomly assigned to receive either MACI or microfracture treatment.
What's involved
You would have a screening arthroscopy to check eligibility and potentially have a cartilage biopsy. Depending on your assigned group, you would receive either MACI or microfracture treatment during this procedure.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for two years after treatment, with measurements taken at baseline and Week 104.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT03588975

A Study of MACI in Patients Aged 10 to 17 Years With Symptomatic Chondral or Osteochondral Defects of the Knee

Recruiting
PHASE3Ages 10–17InterventionalTreatment
Vericel Corporation
~45 participants
Updated 2026-09-10 on ClinicalTrials.gov
What's tested:MACImicrofracture

At a glance

Recruiting sites
11 of 14 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Proportion of Participants Who Achieve ≥ 10-point Improvement From Baseline in KOOS-Child Pain and Function (Sports and Recreational Activities) Subscale Scores
Measured over Baseline and Week 104

Conditions

Chondral Defect
Osteochondritis Dissecans (OCD)
Articular Cartilage Defect
Articular Cartilage Disorder of Knee

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Defect of articular cartilageOsteochondritis Dissecans

NCT03588975

Where you'd take part

This study runs at 14 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Akron Children's Hospital

    Akron, Ohiostudy coordinator listed

    Recruiting

  • Children's Hospital of Wisconsin

    Milwaukee, Wisconsinstudy coordinator listed

    Recruiting

  • Penn Medicine University City

    Philadelphia, Pennsylvaniastudy coordinator listed

    Recruiting

  • Shriners Hospital for Children Northern California

    Sacramento, Californiastudy coordinator listed

    Recruiting

  • Stanford University School of Medicine

    Palo Alto, Californiastudy coordinator listed

    Recruiting

  • The Children's Hospital of Philadelphia - The Hub for Clinical Collaboration

    Philadelphia, Pennsylvaniastudy coordinator listed

    Recruiting

  • The Ohio State University Jameson Crane Sports Medicine Institute

    Columbus, Ohiostudy coordinator listed

    Recruiting

  • University of Michigan Medsport Orthopaedic Surgery

    Ann Arbor, Michiganstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Jonathan Hopper, BSc (Hons), MB ChB, FRCSEd · STUDY_DIRECTOR · Vericel Corporation

Who to contact

Vericel Clinical Affairs
[email protected]
978-347-2876
Email the study team

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Eligibility criteria

Inclusion

Age 10 to 17 years at the time of planned randomization
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).

Exclusion

At least 1 defect size ≥1.5 cm2 on the patella, 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.
Salvageable OCD lesions must have failed prior conservative and a reparative treatment, and the participant still experiences pain associated with the osteochondral lesion. Participants with defects as a result of trauma or unknown etiology are eligible regardless of prior treatments.
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. Meniscal repair or resection might be performed either staged or concurrent with the cartilage repair procedure provided that the surgeon was able to confirm that at least 50% of functional meniscus would remain after the corrective meniscal treatment.
Written informed consent
Any surgery on the target knee joint within 6 months prior to Screening (not including diagnostic arthroscopy)
Previous investigational drug or device use within 3 months prior to Screening
Avascular necrosis of the target knee (other than potential OCD lesion to be treated)
Participants with uninvolved open growth plates where the surgery necessitates crossing the growth plate, or where the depth of the lesion crosses the growth plate
ICRS Grade III or IV chondral or unsalvageable osteochondral defects located on the tibia or any lesion that is bipolar to the index lesion
Malalignment requiring concurrent osteotomy to correct tibial-femoral or patella-femoral alignment (prior guided growth treatment is not exclusionary)
Symptomatic musculoskeletal conditions in the lower limbs that could impede measurement of efficacy for the target knee joint
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
Current malignancy or treatment for malignancy within the past 5 years
Known history of hypersensitivity to gentamicin, other aminoglycosides, or products of porcine or bovine origin
Females who are pregnant or lactating
Participants who, in the opinion of the Investigator, have significant medical or psychosocial problems that warrant exclusion. Examples of significant problems included but are not limited to:
Any condition that has potential for negatively impacting intra or postoperative course
Conditions that limit compliance with rehabilitation program
Any condition that has potential for significantly limiting participant's ability to assess postoperative knee function
Any condition, psychiatric or otherwise, that would preclude informed consent/assent, consistent follow-up, or compliance with any aspect of the study
Participant is currently abusing drugs or alcohol or, in the opinion of the Investigator, at high risk for poor compliance

What this trial measures

  • Proportion of Participants Who Achieve ≥ 10-point Improvement From Baseline in KOOS-Child Pain and Function (Sports and Recreational Activities) Subscale ScoresBaseline and Week 104

    A responder is defined as a participant with ≥ 10-point change (improvement) in both the KOOS-Child Pain and Function (Sports and Recreational activities) scores from Baseline scores. The Knee and Osteoarthritis Outcome Score for Children (KOOS-Child) is a validated knee-specific instrument developed to assess the participant's opinion of their knee and associated problems. KOOS consists of 5 subscales: Pain, Function in sports and recreational activities, other Symptoms, Function in activities of daily living (ADL), and knee related Quality of life (QOL).