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FDA Approves Maci for Knee Cartilage Repair
FDA news release; 2016 Dec 13
The FDA has approved Maci (autologous cultured chondrocytes on porcine collagen membrane) for the repair of symptomatic, full-thickness cartilage defects of the knee in adult patients. Maci, manufactured by Vericel Corporation, headquartered in Cambridge, MA, 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.
Indications: 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.
Dosage/administration: 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 1 defect.
Adverse reactions: The most common adverse reaction reported by people who received Maci were joint pain, common cold-like symptoms, headache, and back pain.
US Food and Drug Administration. FDA approves first autologous cellularized scaffold for the repair of cartilage defects of the knee. FDA Web site. December 13, 2016. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm533153.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery. Accessed December 27, 2016.
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