Chondral DefectPhase 3PEAKNCT03588975
A Study of MACI in Patients Aged 10 to 17 Years With Symptomatic Chondral or Osteochondral Defects of the Knee
A Phase 3 study testing MACI and microfracture in people with Chondral Defect and Osteochondritis Dissecans (OCD), run by Vericel Corporation at 14 sites in United States.
Trial summary
The objective of this study is to compare the efficacy and safety of MACI® vs arthroscopic microfracture in the treatment of participants aged 10 to 17 years with symptomatic articular chondral or osteochondral defects of the knee. Read more about this study
- Who is it for?
- Ages 10 to 17 years
- Conditions the study is for
- Chondral Defect, Osteochondritis Dissecans (OCD), Articular Cartilage Defect
- What is being tested?
- MACI and microfracture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 14 sitesUnited States
- Study dates
- 24 Oct 2018to Feb 2030
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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).
- 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.
- 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.
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- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
14 sites in 1 country. Contact the study team or a site near you to ask about taking part.
14 sites in 1 country
United States14 sites, 11 recruiting
- Recruiting
Akron Children's Hospital
Akron, Ohio, 44308
John Polousky, MD, 330-543-3500, JPolousky@akronchildrens.org
John Polousky
- Recruiting
University of Michigan Medsport Orthopaedic Surgery
Ann Arbor, Michigan, 48106
Christopher Ray, 734-615-0934, raychri@med.umich.edu
Eileen Crawford
- Recruiting
Johns Hopkins Hospital
Baltimore, Maryland, 21224
Rushyuan Jay Lee, MD, 443-997-2663, rlee74@jhmi.edu
Gabrielle Reichard, 410-502-3626, greicha1@jhmi.edu
- Recruiting
The Ohio State University Jameson Crane Sports Medicine Institute
Columbus, Ohio, 43202
Jenna DeFranco, 614-293-2761, jenna.defranco@osumc.edu
Christopher Kaeding
- Completed
Texas' Children Hospital
Houston, Texas, 77094
- Recruiting
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, 53201
John Erickson, DO, 414-337-7325, JErickson2@childrenswi.org
John Erickson
- Recruiting
Ochsner Health System-Elmwood
New Orleans, Louisiana, 70121
Joseph Laurent, 504-842-0263, Joseph.laurent@ochsner.org
Brian Godshaw
- Recruiting
Stanford University School of Medicine
Palo Alto, California, 94304
Amishi Jobanputra, 650-498-4180, amishij@stanford.edu
Kevin Shea
- Recruiting
Penn Medicine University City
Philadelphia, Pennsylvania, 19104
Dorothy Brill, 215-273-5062, dcbrill@upenn.edu
James Carey
- Recruiting
The Children's Hospital of Philadelphia - The Hub for Clinical Collaboration
Philadelphia, Pennsylvania, 19104
Divya Talwar, 215-590-1527, talward@chop.edu
Theodore Ganley
- Completed
Children's Medical Center Plano
Plano, Texas, 75024
- Recruiting
Shriners Hospital for Children Northern California
Sacramento, California, 95817
Kory Bettencourt, 916-453-5030, kbettencourt@shrinenet.org
Brian Haus
- Recruiting
University of California Davis Lawrence J. Ellison Ambulatory Care Center Orthopaedic Surgery
Sacramento, California, 95817
Julia Martin, 916-734-8175, jyhmartin@health.ucdavis.edu
Brian Haus
- Completed
Montefiore Medical Center/Albert Einstein College of Medicine
The Bronx, New York, 10467
About this study
Official 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
The objective of this study is to compare the efficacy and safety of MACI® vs arthroscopic microfracture in the treatment of participants aged 10 to 17 years with symptomatic articular chondral or osteochondral defects of the knee.
Read the detailed description
This is a 2-year prospective, multicenter, randomized, open-label, parallel group clinical trial; a total of 45 participants, ages 10 to 17 years, will be randomized to receive a 1-time treatment with MACI or microfracture (2:1, 30 MACI:15 microfracture).
After meeting screening criteria at the initial visit, all participants will have a screening arthroscopy to further assess study eligibility. During the screening arthroscopy, participants will be further evaluated against entry criteria. Cartilage lesion size will be measured prior to any cartilage repair procedure and randomization. All participants who meet the eligibility criteria and are considered suitable for treatment in the study will have a cartilage biopsy taken prior to randomization to study treatment. Eligible participants will be randomized during the screening arthroscopy procedure to receive either MACI or microfracture treatment. Participants randomized to microfracture will undergo the procedure during the screening arthroscopy.
All biopsied tissue will be sent to the Vericel manufacturing facility in Massachusetts, where the sample will be processed to isolate the autologous chondrocytes. Cells from participants randomized to the MACI group will be used in the preparation of the MACI implant; cells from participants randomized to the microfracture group will be cryopreserved.
Participants randomized to treatment with MACI will return within 12 weeks of the screening arthroscopy to undergo the chondrocyte implantation procedure via arthrotomy. Participants are to follow a recommended postoperative rehabilitation program and compliance with the rehabilitation schedule will be monitored.
Participants will be followed post-study treatment for 2 years (104 Weeks).
- Conditions
- Chondral Defect, Osteochondritis Dissecans (OCD), Articular Cartilage Defect, Articular Cartilage Disorder of Knee
- Being tested
- MACI, microfracture
- Keywords
- OCD, cartilage, cartilage defect
- Medical subject headings
- Osteochondritis Dissecans
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MACIBiological
autologous cultured chondrocytes on porcine collagen membrane
microfractureProcedure or surgery
Arthroscopic microfracture treatment
| Study group | Role | What they receive |
|---|---|---|
| MACI | Experimental | autologous cultured chondrocytes on porcine collagen membrane Receives: Biological: MACI |
| microfracture | Other | surgical procedure Receives: Procedure: microfracture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Participants Who Achieve ≥ 10-point Improvement From Baseline in KOOS-Child Pain and Function (Sports and Recreational Activities) Subscale Scores
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).
Measured: Baseline and Week 104
Secondary outcomes (2)
Change from Baseline in KOOS-Child subscores
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).
Measured: Baseline and Week 104
Change from Baseline in KOOS-Child subscores
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).
Measured: Baseline and Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2018
- Study start24 Oct 2018
- Primary completionFeb 2030 (estimated)
- Study completionFeb 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chondral DefectStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vericel Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jonathan Hopper, BSc (Hons), MB ChB, FRCSEd, Study director, Vericel Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03588975
- Sponsor's protocol ID
- 55-1702-1
- Acronym
- PEAK
- Status last verified
- Oct 2026
- First submitted
- 4 Apr 2018
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT03588975
- Acronym / sponsor ID
- PEAK / 55-1702-1
- Conditions
- Chondral Defect, Osteochondritis Dissecans (OCD), Articular Cartilage Defect, Articular Cartilage Disorder of Knee
- Keywords
- OCD, cartilage, cartilage defect
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Vericel CorporationIndustry (pharma, biotech, devices)
- Study start
- 24 Oct 2018 (actual)
- Primary completion
- Feb 2030 (estimated)
- Study completion
- Feb 2030 (estimated)
- First posted
- 17 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to compare the efficacy and safety of MACI® vs arthroscopic microfracture in the treatment of participants aged 10 to 17 years with symptomatic articular chondral or osteochondral defects of the knee.
Detailed description
This is a 2-year prospective, multicenter, randomized, open-label, parallel group clinical trial; a total of 45 participants, ages 10 to 17 years, will be randomized to receive a 1-time treatment with MACI or microfracture (2:1, 30 MACI:15 microfracture).
After meeting screening criteria at the initial visit, all participants will have a screening arthroscopy to further assess study eligibility. During the screening arthroscopy, participants will be further evaluated against entry criteria. Cartilage lesion size will be measured prior to any cartilage repair procedure and randomization. All participants who meet the eligibility criteria and are considered suitable for treatment in the study will have a cartilage biopsy taken prior to randomization to study treatment. Eligible participants will be randomized during the screening arthroscopy procedure to receive either MACI or microfracture treatment. Participants randomized to microfracture will undergo the procedure during the screening arthroscopy.
All biopsied tissue will be sent to the Vericel manufacturing facility in Massachusetts, where the sample will be processed to isolate the autologous chondrocytes. Cells from participants randomized to the MACI group will be used in the preparation of the MACI implant; cells from participants randomized to the microfracture group will be cryopreserved.
Participants randomized to treatment with MACI will return within 12 weeks of the screening arthroscopy to undergo the chondrocyte implantation procedure via arthrotomy. Participants are to follow a recommended postoperative rehabilitation program and compliance with the rehabilitation schedule will be monitored.
Participants will be followed post-study treatment for 2 years (104 Weeks).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MACI | Experimental | Biological: MACIautologous cultured chondrocytes on porcine collagen membrane |
| microfracture | Other | Procedure: microfracturesurgical procedure |
Who may qualify
- Ages
- 10 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- 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).
- 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.
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MACIautologous cultured chondrocytes on porcine collagen membrane | Biological | MACI |
| microfractureArthroscopic microfracture treatment | Procedure or surgery | microfracture |
Primary outcome
Proportion of Participants Who Achieve ≥ 10-point Improvement From Baseline in KOOS-Child Pain and Function (Sports and Recreational Activities) Subscale Scores
Time frame: Baseline 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).
2 secondary outcomes
Change from Baseline in KOOS-Child subscores
Time frame: Baseline and Week 104
Change from Baseline in KOOS-Child subscores
Time frame: Baseline and Week 52
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Vericel Clinical Trial for Cartilage RepairLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jonathan Hopper, BSc (Hons), MB ChB, FRCSEd study director
Vericel Corporation
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing MACI and microfracture in people with Chondral Defect and Osteochondritis Dissecans (OCD), run by Vericel Corporation at 14 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Vericel Clinical Affairs (978-347-2876, clinicalhotline@vcel.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Participants Who Achieve ≥ 10-point Improvement From Baseline in KOOS-Child Pain and Function (Sports and Recreational Activities) Subscale Scores (time frame: Baseline and Week 104). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.