FDA approves Maci (autologous cultured chondrocytes on porcine collagen membrane) for knee cartilage repair- Vericel Corporation

The FDA has approved Maci (autologous cultured chondrocytes on porcine collagen membrane), from Vericel Corporation, 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 on scaffolds using healthy cartilage tissue from the patient's own knee.

The safety and efficacy of Maci were shown in a two-year clinical trial designed to demonstrate reduced pain and improved function in comparison to microfracture, an alternative surgical procedure for cartilage repair. The trial included 144 patients (72 in each treatment group). A majority of the patients who completed the two-year clinical trial also participated in a three?year follow-up study. Overall efficacy data support a long-term clinical benefit from the use of the Maci implant in patients with cartilage defects. The most common side effect reported by people who received Maci were: joint pain, common cold-like symptoms, headache and back pain.