Genzyme Corporation's Epicel Wins Marketing Approval for Severe Burn Victims
CAMBRIDGE, Mass., Oct. 29 -- Genzyme Corporation announced today that the U.S. Food and Drug Administration (FDA) has granted Epicel(TM) (cultured epidermal autografts) marketing approval under the Humanitarian Device Exemption (HDE) for the treatment of life-threatening wounds resulting from severe burns. 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 is the first xenotransplantation-classified product to be approved in the U.S. because of its inclusion of animal cells.
"We are pleased that the FDA has recognized the importance of Epicel for patients with severe burns," said Alicia Secor, vice president and general manager of the Biosurgical Specialties group within Genzyme that manufactures Epicel. "Epicel has played a critical role in the recovery process of hundreds of patients who have suffered through the trauma of life-threatening burns."
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 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.
Epicel is supplied in grafts, which each consist of a sheet of cultured epidermal cells attached with stainless steel surgical clips to a backing of petrolatum gauze. Enough skin can be grown from a biopsy the size of a postage stamp to cover the entire body. The process takes approximately 16 days and the skin grafts integrate with surrounding tissue 3 to 4 weeks after surgery.
"Epicel has been the most important advance in burn care for the coverage of large total body surface area burn wounds in this decade," said Dr. Rajiv Sood, medical director, Richard M. Fairbanks Burn Center, Indiana University School of Medicine.
Epicel is indicated for use in patients who have deep dermal or full thickness burns comprising a total body surface area of greater than or equal to 30 percent. It may be used in conjunction with split-thickness autografts -- another type of skin graft taken from a patient's body to treat the burned area -- or alone in patients for whom these autografts may not be an option due to the severity and extent of their burns. The effectiveness of the device for this use has not been demonstrated.
Epicel is contraindicated in patients with known hypersensitivity to agents used in the manufacture of Epicel. Epicel should not be used in patients with a known history of anaphylaxis to vancomycin or amikacin. Epicel is cultured in media containing vancomycin and amikacin. Trace quantities of these antibiotics may adhere to the Epicel autograft.
Epicel should not be used in patients with known sensitivities to materials of bovine or murine origin. The cell culture medium used in the culture of Epicel contains bovine serum and the cells co-cultured with murine 3T3 fibroblasts. The medium used to package and transport Epicel does not contain serum; however, trace quantities of bovine derived proteins may be present. This tissue is intended for autologous use and has not been tested for biohazards. Health care providers should handle this product as if infectious agents are present.
During the Epicel manufacturing, patient's cells are co-cultured with mouse cells. Although the mouse cells have been tested and found to be free of bacteria, fungi and virus, an infection can not be excluded. It is also possible that symptoms of an infection may not be seen for months or years. To date, Genzyme Biosurgery is not aware of any infections related to mouse cells. As a safety measure, the Epicel treated patients are precluded from donation of blood or blood parts, tissue, breast milk, egg, sperm, or other body parts for use in humans.
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