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New cartilage patch could help teens with knee damage avoid Long-Term pain

NCT ID NCT03588975

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 45 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2018

Expected to finish

Feb 2030

An estimate. End dates often move.

Lead sponsor

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

10 to 17 years

Sex

Anyone

Healthy volunteers

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

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.

  1. The places running it

    11 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Akron Children's Hospital

    RECRUITING

    Akron, Ohio, 44308, United States

  • Children's Hospital of Wisconsin

    RECRUITING

    Milwaukee, Wisconsin, 53201, United States

  • Children's Medical Center Plano

    COMPLETED

    Plano, Texas, 75024, United States

  • Johns Hopkins Outpatient Center

    RECRUITING

    Baltimore, Maryland, 21224, United States

  • Montefiore Medical Center/Albert Einstein College of Medicine

    COMPLETED

    The Bronx, New York, 10467, United States

  • Ochsner Sports Medicine Institute

    RECRUITING

    New Orleans, Louisiana, 70121, United States

  • Penn Medicine University City

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

  • Shriners Hospital for Children Northern California

    RECRUITING

    Sacramento, California, 95817, United States

  • Stanford University School of Medicine

    RECRUITING

    Palo Alto, California, 94304, United States

  • Texas' Children Hospital

    COMPLETED

    Houston, Texas, 77094, United States

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

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

  • The Ohio State University Jameson Crane Sports Medicine Institute

    RECRUITING

    Columbus, Ohio, 43202, United States

  • University of California Davis Health

    RECRUITING

    Sacramento, California, 95817, United States

  • University of Michigan Medsport Orthopaedic Surgery

    RECRUITING

    Ann Arbor, Michigan, 48106, United States

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