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news.Genzyme has announced that the FDA has granted Epicel marketing approval under the humanitarian device exemption for the treatment of life-threatening wounds resulting from severe burns.
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Epicel is the first xenotransplantation-classified product to be approved in the US because of its inclusion of animal cells. It is a product that can provide permanent skin replacement for burn victims, and is made from a patient’s own skin cells and then grown on a layer of mouse cells to enhance growth.
Epicel has been used in more than 1,000 patients with burn injuries since it was introduced in 1988. The product had been considered a banked human tissue until 1996 when the FDA announced that manipulated autologous cell-based products used for structural repair or reconstruction required regulatory oversight. Genzyme applied for regulatory approval of Epicel in 1999.
Rajiv Sood, medical director for Richard Fairbanks Burn Center, Indiana University School of Medicine, said: “Epicel has been the most important advance in burn care for the coverage of large total body surface area burn wounds in this decade.”