Originally created 05/28/98

FDA approves new bioengineered skin



WASHINGTON -- Sufferers of vein disease may soon try an implant of living, bioengineered skin to help heal serious open sores on their legs.

The Food and Drug Administration on Tuesday approved Apligraf, a "human skin equivalent" billed as a living copy of different layers of human skin. Although it's not the first attempt at an artificial skin, manufacturer Organogenesis Inc. calls it the first one that looks and feels like real human skin.

The FDA approved a narrow use for Apligraf: as a wound dressing used in addition to standard therapy. The FDA said Apligraf may speed healing.

Apligraf is made from cow collagen and cells from the discarded foreskin from newborn circumcisions. Each implant is grown in a lab dish and remains alive for five days prior to implantation. Doctors would have to order it specially for each patient; Organogenesis did not announce a price.

Venous leg ulcers hit 600,000 to 1 million Americans who have poor blood circulation in their legs. Typically, these patients are treated with tight elastic bandages that restrict movement and fluid accumulation until the open sore has time to heal.