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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

Must not have

Any surgery on the target knee joint within 6 months prior to Screening (not including diagnostic arthroscopy)

ICRS Grade III or IV chondral or unsalvageable osteochondral defects located on the patella or tibia or any lesion that is bipolar to the index lesion

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 104

Awards & highlights

No Placebo-Only Group

Pivotal 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.

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.

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.

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.

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I have painful joint or bone cartilage damage.

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I have severe knee cartilage damage that can be treated with surgery.

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Half or more of the cushion in my knee is still there.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I haven't had surgery on my knee, except for a diagnostic look, in the last 6 months.

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I have severe knee cartilage damage.

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I am not pregnant or breastfeeding.

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I have had a severe knee joint infection.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 104

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

Change from Baseline in KOOS-Child subscores

Other study objectives

Treatment Emergent Adverse Events