A new treatment option was approved by the FDA for those with suffering from knee injuries resulting in full-thickness cartilage defects. The new option of Maci was just approved today, the treatment is for the treatment in adult patients for the repair of these injury-related defects. This is the first FDA-approved product that applies tissue engineering to grow cells on scaffolds using healthy knee cartilage tissue from the patient’s knee.
“Different cartilage defects require different treatments, so therapy must be tailored to the patient,” said Celia Witten, Ph.D., M.D., deputy director of the FDA’s Center for Biologics Evaluation and Research. “The introduction of Maci provides surgeons with an additional option for treatment.”The FDA officials said that Maci is composed of the patient’s cells, which are expanded and placed onto an implantable man-made bioresorbable membrane and implanted through a surgical process over the area where the damaged tissue is removed.
During a two-year clinical trial, using 144 patients reduced pain and improved function were reported. These results were in comparison to “microfracture”, an alternative cartilage repair procedure. Following the two-year clinical trial, most of the patients also participated in a three-year follow-up study program. Joint pain, common cold-like symptoms, headaches, and back pain were the most common side effects reported.
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