A promising, revolutionary treatment for life-threatening burns is to be tested in three clinical studies.

The pilot studies will be conducted at the Arizona Burn Center in Phoenix, UW Medicine Regional Burn Center at Harborview Medical Center in Seattle, and at Brooke Army Burn Center in San Antonio, in partnership with Amarantus BioScience. Lonza Walkersville Inc.. And in all three researchers will be growing skin cells for the patients.

Thicker skin?

“The primary goal is to provide a full-thickness skin substitute to assist with wound closure,” explains Michael Peck, M.D., ScD, FACS and Director of Ambulatory and International Outreach Programs at the Arizona Burn Center.

“The product will differ from those currently on the market,” Peck adds, “because both layers of skin (epidermis and dermis) will be present in the skin substitute. The product is primarily directed toward patients with large burn injuries, but eventually may find utility for patients with smaller burns or other types of skin injuries.”

The product, Engineered Skin Substitute (ESS), was invented by Dr. Steven Boyce. It has been used successfully at Shriners Hospitals for Children in Cincinnati for about two decades. The technology involves culturing epidermal cells from the patient that are grown on a layer of fibroblasts, which comes from a well-established cell line.

“'The sooner the patient gets covered with their own skin, the faster the recovery and the fewer reconstructive procedures they need later.'”

How it works

“The fibroblasts act as a dermal substitute, that’s what makes ESS unique,” explains David H. Ahrenholz, M.D. FACS and immediate past-president of the American Burn Association. He is also the former co-director of Regions Burn Center in St. Paul. As for the dermal substitute’s importance, he clarifies: “Just epidermis doesn’t give a durable skin graft.”

Only a small biopsy is needed. Growing ESS takes about four weeks, but advances in cell culturing could shorten the time. Someone with extensive burns will be hospitalized for many months.

Charting the demand

“With ESS, by 30 days you can go to the operating room with multiple square feet,” Ahrenholz claims.

“For years I have waited for this, but it has never been available. The harsh reality is that I had patients die because we couldn’t get this product. Only Amarantus has had the vision and courage to accept the challenge to bring the ESS technology to market.”

Richard J. Kagan, M.D., has used the method together with its inventor at Shriners Hospitals for Children – Cincinnati, where he is Emeritus Chief of Staff. “There isn’t anything as effective as the ESS,” he says. “The existing method [using cultured epidermis alone] was expensive and had poor take rates.”

Rates of success

With ESS, early take rates were 70 to 75 percent. Eventually, this increased to between 90 to 95 percent.

“We did not have to take patients back for regrafting of these sites and we didn’t have to mesh the skin as much. The sooner the patient gets covered with their own skin, the faster the recovery and the fewer reconstructive procedures they need later,” Dr. Kagan explains. “And the cultured skin grows with the patient.”

Knowing how much they could graft allowed planning for staged wound closure. “It changed the way we treated burns,” adds Kagan. “In my mind, this is a phenomenal gift to mankind.”

After many difficulties in bringing it to market, Amarantus became involved. The Armed Forces Institute for Regenerative Medicine (AFIRM) is contributing to the military study. Dr. Kagan will consult, instruct and mentor the pilot sites. “We need to do this large-scale. And it has to be done properly,” he stresses. “I have worked with it for almost 20 years. My hope is that this will be part of most burn care practices.”