Comparing MACI and microfracture treatments for knee cartilage defects in teens

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

This study is testing whether a new cartilage treatment called MACI works better than a standard procedure called microfracture for knee problems in teens aged 10 to 17.

Quick facts

• Phase: PHASE3
• Study type: Interventional
• Enrollment: 45 (estimated)
• Ages: 10 Years to 17 Years
• Sex: All
• Sponsor: Vericel Corporation (industry)
• Locations: 12 sites (Palo Alto, California and 11 other locations)
• Trial ID: NCT03588975 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the efficacy and safety of MACI® compared to arthroscopic microfracture in treating symptomatic articular chondral or osteochondral defects in patients aged 10 to 17 years. The study is a 2-year, multicenter, randomized, open-label trial involving 45 patients who will be assigned to receive either MACI or microfracture treatment. Patients will undergo a screening arthroscopy to assess eligibility and measure cartilage lesion size before randomization. Those in the MACI group will have their chondrocytes processed for implantation, while those in the microfracture group will undergo the procedure during the screening visit.

Who should consider this trial

Good fit: Ideal candidates are adolescents aged 10 to 17 years with symptomatic cartilage or osteochondral defects of the knee that meet specific size and stability criteria.

Not a fit: Patients who have had recent knee surgery or those with certain types of cartilage defects that do not meet the study criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a more effective treatment option for knee cartilage defects in adolescents, potentially leading to improved joint function and reduced pain.

How similar studies have performed: Previous studies have shown promising results with similar cartilage repair techniques, suggesting that this approach may be effective.

Eligibility criteria

Inclusion Criteria:

* 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 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.
* 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.

Exclusion Criteria:

* 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
* 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
* Known history of hypersensitivity to gentamicin, other aminoglycosides, or products of porcine or bovine origin
* Females who are pregnant or lactating

Where this trial is running

Palo Alto, California and 11 other locations

• Stanford University — Palo Alto, California, United States (RECRUITING)
• Shriner's Hospital for Children Northern California — Sacramento, California, United States (RECRUITING)
• University of California Davis Health — Sacramento, California, United States (RECRUITING)
• Ochsner Sports Medicine Institute — New Orleans, Louisiana, United States (RECRUITING)
• Johns Hopkins Outpatient Center — Baltimore, Maryland, United States (RECRUITING)
• University of Michigan — Ann Arbor, Michigan, United States (RECRUITING)
• Akron Children's Hospital — Akron, Ohio, United States (RECRUITING)
• The Ohio State University Jameson Crane Sports Medicine Institute — Columbus, Ohio, United States (RECRUITING)
• Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States (RECRUITING)
• Penn Sports Medicine Center — Philadelphia, Pennsylvania, United States (RECRUITING)
• Texas Children's Hospital — Houston, Texas, United States (WITHDRAWN)
• Medical College of Wisconsin — Milwaukee, Wisconsin, United States (RECRUITING)

Study contacts

• Study coordinator: Mikhail Chkolnik, MD

Conditions: Chondral Defect, Osteochondritis Dissecans, Articular Cartilage Defect, Articular Cartilage Disorder of Knee, OCD, cartilage, cartilage defect