Bioengineered skin wins approval from the FDA

Apligraf approved for venous skin ulcers

The federal Food and Drug Administration has given approval for the use of the human skin equivalent Apligraf in the United States.

Apligraf, manufactured by Organogenesis of Canton, MA, is a full-thickness allographic skin substitute that includes both dermal and epidermal components. It is made from human skin cells mixed with collagen from cattle.

The FDA in late May approved the product for use in treating venous skin ulcers, which are hard to heal because of a lack of blood flow to the skin. "This condition is estimated to affect thousands of Americans each year, and its treatment often requires multiple surgeries," the FDA said in a statement. "Although Apligraf will not eliminate the need for standard treatment, its use may enhance and shorten the healing process."

Two other bioengineered skin equivalents were previously approved by the FDA for use on severe burn victims. Those products are Dermagraft TC, from Advanced Tissue Sciences, La Jolla, CA, and Integra, from Integra LifeSciences Corp., Plainsboro, NJ. (For additional information on the use of bioengineered skin, see Wound Care, January 1998, pp. 1-5, and February 1998, pp. 13-15.)

Novartis Pharmaceuticals Corp. has worldwide marketing rights for Apligraf, the company said in a statement. In addition to venous leg ulcers, Apligraf has been studied in burns and in skin surgery. A trial is under way in diabetic ulcers and one is expected to begin in pressure sores later this year.

Experts say tissue engineering is starting to transform the way patients with flesh wounds are being treated. Apligraf is made with live cells from the foreskin of a newborn's penis - used because babies are regularly circumcised and the tissue is young and available - mixed with tissue from a cow.

"Its special composition allows it to provide wound protection and to foster the growth of healthy new skin,'' the FDA said.