WASHINGTON - The FDA approved a novel product to repair damaged knee cartilage, called MACI, in which a patient's own cartilage tissue is engineered to grow on artificial scaffolds and then implanted.
It's the first such product to win FDA approval, the agency said.
MACI consists of autologous cartilage tissue that is expanded ex vivo and attached to a bioresorbable collagen membrane taken from pigs. It is implanted over damaged or surgically removed areas of knee cartilage. MACI implants contain from 500,000 to 1 million cells per cm2. "Multiple implants may be used if there is more than one defect," the agency said.
Surgeons using MACI must receive special training, the FDA noted.
The approval was based primarily on a 2-year, parallel-group trial in which 144 patients received MACI implants or microfracture procedures, which was followed by a three-year extension study. "Overall efficacy data support a long-term clinical benefit from the use of the MACI implant in patients with cartilage defects," according to the FDA.
Joint pain, common cold-like symptoms, headache, and back pain were the most frequent adverse effects reported in the trial.
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