Spray-on skin that heals burns in days, not weeks, is set to begin clinical trials as soon as next month.
Avita Medical's ReCell technology uses a postage stamp-sized piece of skin from a patient to heal a page's-worth of burned skin. The technology could save the lives of burn victims by reducing the risk of deadly infections as early as next year.
"We need to get these burn wounds closed quickly," said John Geisel, a scientist at Avita Medical developing the technology. "Until we do, these wounds lose blood and a patient runs the risk of a life-threatening infection."
In second and third degree burns, the kind of burns ReCell is designed to heal, the outer few layers of skin are damaged or destroyed. To heal the burned skin scientists currently can either graft skin from another part of the victim's body, or use artificial skin grown in petri dishes, which can come from another donor or from the burn patient.
Grafting is fast with a low chance of rejection but it uses a lot of skin. For a patient that has burned 40 to 50 percent of their body grafting isn't much of an option; to cover a page's-worth of burned skin requires a page's-worth of healthy skin be removed.
Artificially grown skin from another donor is fast but also raises the risk of rejection, which can further increase the chance of a life-threatening infection. Skin can be grown using a patients own cells, harvested from a much smaller area than a full graft, which is more reliable but takes weeks to grow.
ReCell combines the speed and reliability of a skin graft with the small donor site of artificially grown skin. As little as six one-thousands of an inch-deep of skin is scraped from an area the size of a postage stamp. Once taken, the donor site looks like a small rug burn, raw and pink with pinprick bleeding. A full graft leaves the donor site bleeding.
Contained in those six-thousands of an inch are basal stem cells and melanocytes, cells that give skin its particular color and texture. The structural materials holding these cells in place are dissolved with trypsin, a enzyme harvested from pigs, and then sprayed back onto a burn site.
Once on the burned area, the skin stem cells and melanocytes begin to divide and expand. In less than a week that stamp-sized donor site of skin can turn into a page's worth of new, healthy skin. Skin that matches the tone and texture of the original skin more closely than skin grafts usually do.
A clinical trial of ReCell, using 106 patients with second degree burns, is set to begin in December and end about one year later. If the Food and Drug Administration approves, ReCell could be available for purchase soon after the clinical trial is completed. ReCell is already available for use in Mexico, Canada, Europe and several other countries.
Part of the funding for the clinical trial comes from a $1.4 million U.S. Army grant to help develop regenerative medicine for wounded soldiers returning from battle. James Holmes, a doctor at the Wake Forest Institute for Regenerative Medicine, is running the clinical trial. Holmes expects that if ReCell is approved for use in the United States, it will save the lives of burn victims.
"What's available today is the same technology that was available 30 years ago," said Holmes.
"In a burn you are always working against time. ReCell will allow us to turn back the clock on all kinds of burns."