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MACI · 1 trial · 4 indications
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).
| Arm | Type | Description |
|---|---|---|
| MACI | EXPERIMENTAL | autologous cultured chondrocytes on porcine collagen membrane |
| microfracture | OTHER | surgical procedure |
| Name | Type | Description |
|---|---|---|
| MACI | BIOLOGICAL | autologous cultured chondrocytes on porcine collagen membrane |
| microfracture | PROCEDURE | Arthroscopic microfracture treatment |
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 determin...
MACI is used for the treatment of symptomatic chondral or osteochondral defects of the knee. It is being studied in patients aged 10 to 17 years with these conditions, including chondral defects, osteochondritis dissecans, and articular cartilage defects or disorders of the knee.
MACI is developed by Vericel Corporation, a biopharmaceutical company. Vericel is publicly traded under the ticker symbol VCEL on the stock market.
MACI is in Phase 3 clinical development. It is an investigational product being studied for the treatment of symptomatic chondral or osteochondral defects of the knee in adolescent patients. It has not yet been approved for this indication.
MACI is being evaluated in a Phase 3 clinical trial with the identifier NCT03588975. This study is recruiting patients aged 10 to 17 years with symptomatic chondral or osteochondral defects of the knee. The trial is a controlled, randomized study with an enrollment target of 45 participants.
MACI is classified as a monoclonal antibody modality in the investigational product category. It is being studied for musculoskeletal conditions, specifically for the repair of cartilage defects in the knee.