FDA News - December 2016

VBCR - December 2016, Vol 5, No 6 - FDA Approvals, News & Updates

Maci Approved for the Reparation of Cartilage Defects

On December 13, 2016, the FDA approved Maci, a cellular scaffold comprised of autologous cultured chondrocytes on porcine collagen membrane (Vericel Corporation), for the reparation of symptomatic knee cartilage defects 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.

Knee cartilage damage can occur as a result of muscle weakness, overuse, general wear and tear, straining beyond normal motion, or injury.

“Different cartilage defects require different treatments, so therapy must be tailored to the patient. The introduction of Maci provides surgeons with an additional option for treatment,” said Celia Witten, PhD, MD, Deputy Director, Center for Biologics Evaluation and Research, FDA, Silver Spring, MD.

Maci is constructed using a patient’s own cells, which are then extended and placed on a bioresorbable collagen membrane that is derived from porcine. Every Maci implant comprises a small sheet that contains 500,000 to 1,000,000 cells per cm2. The membrane is then surgically implanted over the section of the patient’s knee where damaged tissue was removed.

The FDA advises that administration of Maci should be performed by a surgeon who has been specifically trained in how to use this cellular scaffold. Maci can be trimmed down to size according to the extent of the cartilage defect, ensuring that the damaged section is covered entirely. In cases where >1 defect is present, multiple implants can be used.

According to results of a 2-year trial comparing the use of Maci with micro­fracture (an alternative surgical procedure for repairing cartilage), patients with cartilage defects experience long-term benefits from the use of the Maci implant.

Joint pain, back pain, headache, and symptoms similar to those of a common cold were the most common side effects reported by patients who received a Maci implant.

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