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Cell Therapy

MACI vs Microfracture for Knee Cartilage Injury (PEAK Trial)

Phase 3
Recruiting
Research Sponsored by Vericel Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
At least 1 defect size ≥1.5 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
Symptomatic cartilage or osteochondral defects
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 104
Awards & highlights

PEAK Trial Summary

This trial is comparing two different treatments for knee injuries in young patients. One is a newer method called MACI, while the other is a more traditional approach called microfracture.

Who is the study for?
This trial is for young people aged 10-17 with knee problems like cartilage damage or osteochondritis. They should have a specific type of severe cartilage injury that can be treated surgically, and their knee must be stable. It's not for those who've had recent surgery on the same knee, are pregnant, have certain allergies, or joint conditions like rheumatoid arthritis.Check my eligibility
What is being tested?
The study compares two treatments for serious knee cartilage injuries in youth: MACI (a cell-based implant) and microfracture (a surgical technique). The goal is to see which one is safer and works better at repairing the damaged areas in the knees of these patients.See study design
What are the potential side effects?
Possible side effects from MACI may include pain at the implant site, infection risks, swelling, and tissue overgrowth. Microfracture might cause joint pain, swelling, stiffness or bleeding inside the joint.

PEAK Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have a knee injury larger than 1.5 cm2 but no deeper than 6 mm.
Select...
I have painful joint or bone cartilage damage.
Select...
I have severe knee cartilage damage that can be treated with surgery.
Select...
Half or more of the cushion in my knee is still there.

PEAK Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 104
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 104 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Proportion of Patients Who Achieve at Least a 10-point Improvement From Baseline in KOOS-Child Pain and Function (Sports and Recreational Activities) Scores
Secondary outcome measures
Change from Baseline in KOOS-Child subscores
Other outcome measures
Treatment Emergent Adverse Events

PEAK Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: MACIExperimental Treatment1 Intervention
autologous cultured chondrocytes on porcine collagen membrane
Group II: microfractureActive Control1 Intervention
surgical procedure

Find a Location

Who is running the clinical trial?

Vericel CorporationLead Sponsor
13 Previous Clinical Trials
3,007 Total Patients Enrolled
Jonathan HopperStudy DirectorVericel Corporation

Media Library

MACI (Cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03588975 — Phase 3
Osteoarthritis Research Study Groups: MACI, microfracture
Osteoarthritis Clinical Trial 2023: MACI Highlights & Side Effects. Trial Name: NCT03588975 — Phase 3
MACI (Cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03588975 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are any adults above the age of 20 currently enrolled in this experiment?

"Children aged 10-17 may be eligible for this study, as seen in the inclusion criteria. Out of the 4 clinical trials for minors and 6 investigations for elderly patients, this is one of the latter."

Answered by AI

Is MACI a secure medical treatment for patients?

"There have been multiple rounds of clinical trials that support the safety of MACI, as it is a Phase 3 medication."

Answered by AI

Could you inform me as to how many patients are included in this clinical trial?

"Yes, this study is recruiting patients. The clinicaltrials.gov website shows that the first posting was on 10/24/2018 and the most recent update was on 10/18/2021. 45 people are needed at 10 different locations."

Answered by AI

Are new participants being allowed to join the research project?

"The most recent information on clinicaltrials.gov suggests that this trial is still looking for participants. The listing was first created on October 24th, 2018 and updated as recently as October 18th, 2021."

Answered by AI

Who else is applying?

What site did they apply to?
University of California Davis Health
Johns Hopkins Outpatient Center
Medical College of Wisconsin
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
3+

Why did patients apply to this trial?

Tried of the pain. Severe arthritis in both knees.
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
A Study of MACI in Patients Aged 10 to 17 Years With Symptomatic Chondral or Osteochondral Defects of the Knee
2018. "A Study of MACI in Patients Aged 10 to 17 Years With Symptomatic Chondral or Osteochondral Defects of the Knee". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03588975.
~16 spots leftby Jun 2027
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