New cartilage patch could help teens with knee damage avoid Long-Term pain
NCT ID NCT03588975
First seen Jun 25, 2026 · Last updated Sep 11, 2026 · Updated 3 times
Summary
This study tests whether a lab-grown cartilage implant (MACI) works better than a standard surgery (microfracture) for teens aged 10-17 with knee cartilage damage. About 45 participants will receive either treatment and be followed for improvements in pain and sports function. The goal is to see if MACI helps teens recover more fully and avoid future knee problems.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- MACI (lab-grown cartilage cells on a collagen patch)
- What this could lead to
- If successful, this could offer teens with knee cartilage damage a more effective treatment than microfracture, potentially improving pain and ability to play sports.
- What could go wrong
- This is a small Phase 3 trial with only 45 participants, so results may not apply to everyone. MACI requires surgery and recovery, and it's not a cure—ongoing joint issues may remain.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 45 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2018
- Expected to finish
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Feb 2030
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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10 to 17 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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). 1. Concurrent ICRS Grade I and II defects are acceptable on the tibia if they remain untreated (or are treated with debridement only) at the time of study treatment. 2. Participants with a potentially re-attachable osteochondral fragment, identified by magnetic resonance imaging (MRI) and that has not previously been repaired, may be consented to the study and undergo baseline assessments per protocol and prior to confirmatory arthroscopy (Visit 2). At arthroscopy, an attempt will be made to reattach the osteochondral fragment. If this is successful, the participant will be excluded from the study and deemed an intra-operative screen failure. If the attempted reattachment fails and no other exclusion criteria apply, the participant may continue in the PEAK study: a MACI biopsy will be taken, the participant will be randomized and treated per protocol. * 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 Exclusion Criteria: * 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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
11 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Akron Children's Hospital
RECRUITINGAkron, Ohio, 44308, United States
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Children's Hospital of Wisconsin
RECRUITINGMilwaukee, Wisconsin, 53201, United States
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Children's Medical Center Plano
COMPLETEDPlano, Texas, 75024, United States
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Johns Hopkins Outpatient Center
RECRUITINGBaltimore, Maryland, 21224, United States
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Montefiore Medical Center/Albert Einstein College of Medicine
COMPLETEDThe Bronx, New York, 10467, United States
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Ochsner Sports Medicine Institute
RECRUITINGNew Orleans, Louisiana, 70121, United States
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Penn Medicine University City
RECRUITINGPhiladelphia, Pennsylvania, 19104, United States
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Shriners Hospital for Children Northern California
RECRUITINGSacramento, California, 95817, United States
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Stanford University School of Medicine
RECRUITINGPalo Alto, California, 94304, United States
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Texas' Children Hospital
COMPLETEDHouston, Texas, 77094, United States
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The Children's Hospital of Philadelphia - The Hub for Clinical Collaboration
RECRUITINGPhiladelphia, Pennsylvania, 19104, United States
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The Ohio State University Jameson Crane Sports Medicine Institute
RECRUITINGColumbus, Ohio, 43202, United States
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University of California Davis Health
RECRUITINGSacramento, California, 95817, United States
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University of Michigan Medsport Orthopaedic Surgery
RECRUITINGAnn Arbor, Michigan, 48106, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Knee cartilage repair: can ACI surgery get you moving again?
- Knee cartilage repair: Lab-Grown cells vs. surgery – which works better?
- Knee cartilage surgery showdown: which technique wins?
- Knee cartilage repair: your own cells could be the key
- Knee OCD study seeks best treatment path
- New knee implant aims to repair cartilage and avoid repeat surgery