What is EPICEL
What is EPICEL and how it may help.
EPICEL is a cultured epidermal autograft (CEA)—a skin graft grown from a patient’s own skin. These grafts provide a permanent skin replacement for patients who have deep dermal or full thickness burns comprising a total body surface area of greater than or equal to 30%. From 2 postage stamp-sized biopsies, Genzyme can grow enough skin to cover the patient’s entire body.
Who is it for?
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%. It may be used in conjunction with split-thickness autografts, or alone in patients for whom split-thickness autografts may not be an option due to the severity and extent of their burns. Please see the complete EPICEL Directions for Use (PDF) for important safety and usage considerations.
EPICEL is a skin graft product that is approved by the FDA for use as a humanitarian use device (HUD).
An HUD is a device that is intended to benefit patients by treating or diagnosing a disease or condition that affects or is manifested in fewer than 4,000 individuals in the United States per year. The effectiveness of EPICEL has not been proven in clinical studies.
How is it made?
To make EPICEL, a small biopsy of the patient’s healthy skin is obtained, placed into transport media, and packaged into a specially designed transport kit supplied by the Genzyme cell-processing facility. The biopsy is shipped to the cell processing facility where the cells (keratinocytes) are cultured aseptically for a period of several weeks to expand the cell population into many skin grafts. The resulting grafts are sheets of skin approximately 50 cm2 and two to eight cell layers thick. Upon completion and release, the grafts are hand-delivered by a Genzyme representative to the burn center operating room.