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ReCell, a new spray-on skin-regeneration technology that uses the patient's own cells, has the potential to "alter the way we graft humans forever," a researcher says.
The ReCell (Avita Medical) approach to wound healing is "fabulously disruptive technology," James H. Holmes IV, M.D., F.A.C.S., told the Translational Regenerative Medicine Forum meeting here in April.
The technique uses a standard dermatome to take a split-thickness sample of skin about the size of a postage stamp; a proprietary solution to dissolve bonds between the cells in the sample; and a spray applicator to deliver the suspended cells to the wound areas.
All of the elements for the procedure are in a small, self-contained kit, and processing takes about 20 minutes in the operating room. One sample and kit can cover up to 80 times the area of the original skin sample.
Benefits of the approach include the need for only a minimal donor sample compared with skin grafts; accelerated healing; minimized scar formation; elimination of tissue rejection; and reintroduction of pigmentation to the skin, according to Avita Medical, which licensed ReCell.
Developed in Australia
The technology, developed in Australia by Fiona Wood, M.D., is approved for use in Europe and elsewhere, and has been used for a variety of dermatologic purposes - wound healing, scar revision, treatment of vitiligo - in more than 10,000 patients. But internal and funding issues delayed Avita's clinical trial in the United States, required to gain approval from the Food and Drug Administration (FDA).
That began to change about a year ago with the opening of a multicenter clinical trial of ReCell in 106 burn patients. Dr. Holmes is the principal investigator of the study and assistant professor of surgery at Wake Forest University School of Medicine, Winston-Salem, N.C.
The Armed Forces Institute of Regenerative Medicine (AFIRM) is co-sponsoring the trial and supporting it with $2 million as the lead element of a new five-year regenerative medicine program designed to better help injured soldiers.
To qualify for the trial, a patient must have burns over less than 20 percent of total body surface area "and have two areas ranging in size from 100 square cm to 320 square cm of similar severity deep partial-thickness burn requiring a skin graft, in similar anatomic locations," Dr. Holmes says. The wounds are randomized to ReCell or standard of care 2:1 meshed split-thickness autografting. Patients will be followed for a year.
"Since 1975, there have only been two operative advancements for burns, cultured epithelial autografts, i.e., Epicel (Genzyme), and Integra (dermal regeneration template, Integra LifeSciences). There is extreme inter-user variability in the outcomes using Epicel and Integra; some people can get it to work, some people can't," Dr. Holmes said at the April forum. "There also are issues of cost and availability" and "no outcomes data."
So Dr. Holmes was intrigued by what he saw in the limited literature on ReCell and frustrated by its lack of approval for use in the United States. While he is careful not to say anything about the ongoing trial that might compromise its integrity, Dr. Holmes does say that the incomplete outcomes he has seen to date are consistent with what has been published in the peer-reviewed medical literature.