FDA approves engineering produced tissue on scaffolds using healthy cartilage tissue from the patient’s own knee for the repair of cartilage defects of the knee
The U.S. Food and Drug Administration has approved Maci (Maci is manufactured by Vericel Corporation, headquartered in Cambridge, Ma.) for the repair of symptomatic, full-thickness cartilage defects of the knee in adult patients. Maci is the first FDA-approved product that applies the process of tissue engineering to grow cells using healthy cartilage tissue from the patient’s own knee.
Cartilage defects in the knee can result from an injury, straining the knee beyond its normal motion, overuse, muscle weakness and general wear and tear.
Maci is composed of a patient’s own (autologous) cells that are expanded and placed onto a bio-resorbable (can be broken down by the body) porcine-derived collagen membrane that is implanted over the area where the defective or damaged tissue was removed. The operation should be performed by a surgeon specifically trained in the use of Maci.
The amount of Maci administered depends on the size of the cartilage defect, and is trimmed to ensure that the damaged area is completely covered. Multiple implants may be used if there is more than one defect.
The Maci safety and efficiency were shown in a two-year clinical trial designed to demonstrate reduced pain and improved function in comparison to an alternative surgical procedure for cartilage repair. Overall efficacy data support a long-term clinical benefit from the use of the Maci implant in patients with cartilage defects.