Artificial skin approved for blistering disease

Monday, February 26th 2001, 12:00 am
By: News On 6

WASHINGTON (AP) -- It's a rare but devastating inherited disease -- children's skin severely blisters at the slightest touch, sometimes so badly that scarring eventually melds their fingers together like a mitten.

The U.S. Food and Drug Administration approved Thursday an artificial skin that may help some of those patients heal when the disease gets so bad that their fingers must be surgically separated.

The "composite cultured skin" made by New York-based Ortec International Inc. will be available to hospitals by May.

The artificial skin is made of living skin cells specially grown in laboratory dishes using cow collagen and the foreskins from circumcised newborn boys.

The inherited blistering disease is called epidermolysis bullosa. A genetic defect leaves patients' skin missing certain proteins that anchor the skin to the body.

Some patients have a mild form of the disease, while others have life-threatening open blisters covering most of their bodies.

There is no treatment other than trying to protect the skin and to heal open blisters.

The new artificial skin is aimed at a severely affected subset of patients. About 4,000 people a year are diagnosed with "dystrophic EB," a form of the disease so sever that patients suffer the "mitten hand deformity," said FDA medical reviewer Charles Durfor.

Until now, surgeons who separated the fingers had to wrap them for healing in non-sticky bandages, or use skin grafts from other parts of patients' bodies. Healing takes a long time, risking infection -- and skin grafts leave additional hard-to-heal wounds on other parts of patients' bodies.

Australian surgeons patched the new artificial skin onto seven patients' fingers, and found it helped them heal quickly without infection. A second study of 12 Americans with EB blisters elsewhere on the body helped confirm the product is safe, Durfor said.

Ortec said the EB treatment will cost between $1,000 and $5,000, depending on the severity of the case.

A competing product called Apligraf also is being studied against EB.