Tags: knee | repair | FDA

FDA Approves Use of Patient's Tissue for Knee Repair

FDA Approves Use of Patient's Tissue for Knee Repair

(Copyright Fotolia)

By    |   Friday, 16 December 2016 02:25 PM EST

The U.S. Food and Drug Administration (FDA) has approved a product that uses a patient’s own tissue to repair their knee.

This is the first time such a product has received FDA approval, the regulatory agency noted in a statement.

The product, which is known as Maci (autologous cultured chondrocytes on porcine collagen membrane), is designed for the repair of knee problems involving cartilage defects, the FDA says.

According to the FDA, Maci applies the process of tissue engineering to grow cells on scaffolds using healthy cartilage tissue from the patient’s own knee.

Knee problems are common, and occur in people of all ages. Cartilage defects in the knee can result from an injury, straining the knee beyond its normal motion, or can be caused by overuse, muscle weakness, and general wear and tear.

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.

A surgeon specially trained in the use of the product should administer it, the FDA says.

"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," Dr. Celia Witten, deputy director of the FDA's Center for Biologics Evaluation and Research, said in a statement.

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 FDA says.

Joint pain, common cold-like symptoms, headache and back pain were the most common side effects reported, the agency adds.

The new product is manufactured by Vericel Corporation, which is headquartered in Cambridge, Massachusetts.

 

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Health-News
A new product that repairs knees using the patient's own tissue has won FDA approval.
knee, repair, FDA
351
2016-25-16
Friday, 16 December 2016 02:25 PM
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