| Home | FDA approval expected for knee cartilage process that cultures patients' cells posted 7-11-97 The Food and Drug Administration is soon expected to approve a novel knee-cartilage replacement product that uses laboratory-grown cells for reparations. In a recent letter to the manufacturer, Genzyme Corp., FDA officials confirmed that the product has proved safe and effective. The letter also enumerated "relatively minor" glitches Genzyme must clear up before approval, said a FDA spokesperson. The product, Carticel, uses a commercial process to culture a patient’s own cells for repairing lesions of articular knee cartilage. The process involves taking a small sample from the patient’s knee and shipping it to a laboratory, where millions of cells are grown from the sample. A surgeon then removes dead tissue and inserts the living cells into the knee, where they attach and multiply over time. A small piece of tissue from the patient’s lower leg is used to hold the new cells in place. Genzyme says the product works where traditional surgical scraping techniques fail and could benefit as many as 12,000 people in the United States annually. Typically, candidates are those with sports injuries and other usage traumas. Carticel is not appropriate for treating generalized arthritis. If effective and affordable, the product could revolutionize knee repair. Benefits from arthroscopic surgery tend to be short-lived, and total knee replacements—performed on about 200,000 people in the United States annually—give out after about 10 to 15 years. In the United States, Carticel has been used to treat more than 600 patients since 1995. But while patients have testified before an FDA advisory committee that their knees were dramatically improved with the product, some surgeons say proof of its effectiveness remains inconclusive. To gather more evidence, researchers will conduct a five-year study to compare Carticel to current treatments. Placebo surgeries are also in the works that would involve moving tissue from the lower leg without inserting cultured cells. FDA officials have allowed Genzyme to market its creation as an unregulated service for more than two years. Once approved, probably by the end of the summer, Carticel will be the first product regulated under 1995 FDA guidelines for products made from patients’ own living cells. Genzyme expects to get "accelerated approval" for Carticel, meaning the company can continue to market unless follow-up studies reveal a problem. In the meantime, Genzyme reported that the FDA’s steps toward approval are bolstering insurance coverage for the patented procedure. Related Sites
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