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MACI · 3 trials · 4 indications
The FAOS is a 42-item, patient-reported outcome measure that assesses foot and ankle health in the past week. There are five FAOS subscales: Pain, Symptoms, Function (Daily Living), Function (SRA), and Foot and Ankle Related Quality of Life. The FAOS has been validated for a variety of foot and ankle conditions, including OLT. Responses to each question on the FAOS are recorded on a 5-point Likert scale. A normalized score out of 100 is calculated for each subscale, with 0 indicating extreme symptoms and 100 no symptoms. Selection of this composite primary endpoint is consistent with FDA guidance recommending selection of primary endpoints that evaluate changes in Pain and Function (SRA) subscale scores as they represent clinically meaningful outcomes for participants who receive products intended to repair or replace damaged cartilage in the knee.
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).
The KOOS is a validated knee-specific instrument developed to assess the patients' 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). A 5-point Likert scale was used to record the response to each item ranging from 0 (no problems) to 4 (extreme problems). Within each subscale, items were added up and normalized to a value between 0 (extreme problems) and 100 (no problems). Subscales are not combined to calculate a total score.
| Arm | Type | Description |
|---|---|---|
| MACI | EXPERIMENTAL | autologous cultured chondrocytes on porcine collagen membrane |
| Bone Marrow Stimulation | OTHER | Surgical procedure |
| microfracture | OTHER | surgical procedure |
| Name | Type | Description |
|---|---|---|
| autologous cultured chondrocytes on porcine collagen membrane | BIOLOGICAL | An autologous cellularized scaffold combination product being studied for the repair of symptomatic, single or multiple full-thickness cartilage defects of the talus with or without bone involvement in adults. |
| Bone Marrow Stimulation | PROCEDURE | A surgical awl or microdrill will be used to make multiple holes in the exposed base of the lesion. The microfracture procedure should result in holes that are approximately 3 to 4 mm apart. When fat droplets can be seen coming from the marrow cavity, the appropriate depth (approximately 2 to 4 mm) has been reached. The released marrow elements (including mesenchymal stem cells, growth factors, and other healing proteins) form a surgically induced clot that provides an enriched environment for new tissue formation. |
| MACI | BIOLOGICAL | autologous cultured chondrocytes on porcine collagen membrane |
| microfracture | PROCEDURE | Arthroscopic microfracture treatment |
Inclusion Criteria: 1. Age 17 to 65 at the time of planned randomization visit (Visit 2). 2. One or more symptomatic chondral or osteochondral lesion/s as defined by FAOS Pain score ≤ 50 and FAOS Function (SRA) score ≤ 50. 3. International Cartilage Repair Society (ICRS) Score Grade 3 or 4 chondral...
MACI is used to treat symptomatic articular cartilage defects and chondral defects. It is being studied in the knee, including in patients with osteochondritis dissecans, and in the ankle. The product is an autologous cultured chondrocytes on porcine collagen membrane, meaning it uses the patient's own cartilage cells.
MACI is developed and manufactured by Vericel Corporation, which trades on the Nasdaq under the ticker VCEL. Vericel is the sponsor of the clinical trials evaluating MACI in cartilage defects of the knee and ankle.
MACI is in Phase 3 clinical development. Two Phase 3 trials are currently recruiting, and one Phase 3 trial has been completed. The completed trial compared MACI with microfracture treatment in patients with symptomatic articular cartilage defects of the knee.
MACI is being evaluated in two recruiting Phase 3 trials: NCT06915233 in patients aged 17 to 65 with chondral or osteochondral defects of the ankle, and NCT03588975 in patients aged 10 to 17 with chondral or osteochondral defects of the knee. A completed Phase 3 trial, NCT00719576, studied MACI versus microfracture in the knee.