45 Participants Needed

MACI vs Microfracture for Knee Cartilage Injury

(PEAK Trial)

Recruiting at 10 trial locations
AE
DW
MC
ME
KM
Overseen ByKristin M Tripp, BS
Age: < 18
Sex: Any
Trial Phase: Phase 3
Sponsor: Vericel Corporation
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

The objective of this study is to compare the efficacy and safety of MACI® vs arthroscopic microfracture in the treatment of patients aged 10 to 17 years with symptomatic articular chondral or osteochondral defects of the knee.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is MACI safe for treating knee cartilage injuries?

MACI (Matrix-induced Autologous Chondrocyte Implantation) has been approved by the U.S. Food and Drug Administration for treating knee cartilage defects, indicating it meets safety standards. Research shows patients generally do well after the procedure, with improvements lasting up to 5 years.12345

How does the MACI treatment differ from other treatments for knee cartilage injury?

MACI (Matrix-induced Autologous Chondrocyte Implantation) is unique because it uses a patient's own cultured cartilage cells on a collagen membrane to repair knee cartilage, potentially offering better surgical handling and patient comfort compared to microfracture, which involves creating small fractures in the bone to stimulate cartilage growth.12678

What data supports the effectiveness of the treatment MACI for knee cartilage injury?

MACI (Matrix-induced Autologous Chondrocyte Implantation) has been approved by the US FDA for treating knee cartilage defects, and it is known to improve surgical handling and patient comfort. It has been used since 2000 for repairing knee cartilage, and studies suggest it may allow for faster rehabilitation compared to traditional methods.12378

Who Is on the Research Team?

JH

Jonathan Hopper

Principal Investigator

Vericel Corporation

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

My knee's crucial ligaments are stable, possibly after surgery.
I have a knee injury larger than 1.5 cm2 but no deeper than 6 mm.
I have painful joint or bone cartilage damage.
See 2 more

Exclusion Criteria

I haven't had surgery on my knee, except for a diagnostic look, in the last 6 months.
I have a condition like arthritis or psoriasis that affects my joints.
I have severe knee cartilage damage.
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

Up to 12 weeks
1 visit (in-person) for screening arthroscopy

Treatment

Participants receive either MACI or microfracture treatment

1-time procedure within 12 weeks of screening
1 visit (in-person) for treatment

Rehabilitation

Participants follow a recommended postoperative rehabilitation program

12 weeks
Regular monitoring for compliance

Follow-up

Participants are monitored for safety and effectiveness after treatment

104 weeks
Regular follow-up visits

What Are the Treatments Tested in This Trial?

Interventions

  • MACI
  • Microfracture
Trial Overview 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.
How Is the Trial Designed?
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

MACI is already approved in United States, European Union for the following indications:

🇺🇸
Approved in United States as MACI for:
  • Symptomatic articular cartilage defects of the knee
🇪🇺
Approved in European Union as MACI for:
  • Symptomatic articular cartilage defects of the knee

Find a Clinic Near You

Who Is Running the Clinical Trial?

Vericel Corporation

Lead Sponsor

Trials
14
Recruited
3,100+

Published Research Related to This Trial

In a randomized controlled trial involving 144 patients, the 5-year follow-up showed that autologous cultured chondrocytes on porcine collagen membrane (MACI) significantly improved pain and function in patients with knee cartilage defects compared to microfracture treatment.
The study found no major safety concerns with MACI, indicating it is a reliable treatment option for symptomatic cartilage defects, with improvements in daily activities and quality of life maintained over the 5-year period.
Matrix-Applied Characterized Autologous Cultured Chondrocytes Versus Microfracture: Five-Year Follow-up of a Prospective Randomized Trial.Brittberg, M., Recker, D., Ilgenfritz, J., et al.[2022]
A study involving 1000 adult patients treated with MACI (autologous cultured chondrocytes on porcine collagen membrane) for knee cartilage repair showed that the majority had a single defect, with an average defect size of 4.7 cm², and a low adverse event rate of only 2.6%.
The patient demographics and defect characteristics in this U.S. study were consistent with previous European trials, indicating that MACI is a viable treatment option for knee cartilage defects, particularly as treatment of multiple defects is more common in the U.S.
Use of MACI (Autologous Cultured Chondrocytes on Porcine Collagen Membrane) in the United States: Preliminary Experience.Carey, JL., Remmers, AE., Flanigan, DC.[2022]
In a study of 30 patients who underwent matrix-induced autologous chondrocyte implantation (MACI), the histological quality of the repaired knee cartilage was assessed, revealing that only 30% of biopsies were classified as normal, indicating that many repairs may still be maturing.
The study found no significant correlation between the macroscopic appearance of the repair tissue and the actual histological quality or the patients' functional status, suggesting that visual assessments may not accurately reflect the true state of cartilage repair.
Matrix-induced autologous chondrocyte implantation (MACI) in the knee.Enea, D., Cecconi, S., Busilacchi, A., et al.[2021]

Citations

Matrix-Applied Characterized Autologous Cultured Chondrocytes Versus Microfracture: Five-Year Follow-up of a Prospective Randomized Trial. [2022]
Use of MACI (Autologous Cultured Chondrocytes on Porcine Collagen Membrane) in the United States: Preliminary Experience. [2022]
Matrix-induced autologous chondrocyte implantation (MACI) in the knee. [2021]
Clinical and magnetic resonance imaging-based outcomes to 5 years after matrix-induced autologous chondrocyte implantation to address articular cartilage defects in the knee. [2019]
Arthroscopic versus open matrix-induced autologous chondrocyte implantation: results and implications for rehabilitation. [2019]
Open Implantation of Autologous Chondrocytes Cultured on Porcine Collagen Membrane for the Treatment of a Full-Thickness Patellar Cartilage Lesion. [2020]
[MRI in the follow-up of matrix-supported autologous chondrocyte transplantation (MACI) and microfracture]. [2022]
Is implantation of autologous chondrocytes superior to microfracture for articular-cartilage defects of the knee? A systematic review of 5-year follow-up data. [2019]
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of Service·Privacy Policy·Cookies·Security