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A topical burn treatment from Mallinckrodt plc division Stratatech Corporation has been approved by the US Food and Drug Administration.

StrataGraft is indicated to treat adults with thermal burns in which some deep skin layers remain intact, also known as deep partial thickness burns. The therapy is produced from two kinds of human skin cells, keratinocytes and dermal fibroblasts, that grow together to make a cellularized scaffold that helps the patient’s skin heal. The FDA noted that the initial keratinocyte cells were grown using mouse cells, although the those cells weren’t used in the final manufacturing process.

The treatment is applied to the burn by a health care provider. It offers an alternative to autograft procedures, in which damaged skin is replaced with healthy skin taken from elsewhere on the body. Patients treated with StrataGraft require less skin to be taken for grafting, leading to decreased scarring and shorter hospital stays.

In two randomized trials of 101 adults, burns treated with StrataGraft were more likely to close completely and saw a significantly decreased need for autografts, the FDA said. Common side-effects included itching, blisters, scarring and stalled healing of the treatment site. However, the FDA says the overall safety profile was similar to that of autografting.

Acting FDA commissioner Janet Woodcock praised the approval on Twitter.


The FDA granted StrataGraft regenerative medicine advanced therapy (RMAT), Priority Review and Orphan Drug designations. The treatment was developed with an $86m grant from the Department of Health and Human Services’ Biomedical Advanced Research and Development Authority (BARDA), which is interested in the potential of alternative burn treatments for use during mass casualty events.

“Serious burns can be an incredibly difficult injury to treat and can adversely affect more than just the skin. The goal of burn management is to help the patient return to the highest level of functionality and independence possible, while improving the overall quality of life,” Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said in a statement. “This approval provides health care professionals a novel way to treat burn wounds.”

This is the second alternative burn treatment to garner approval in recent days. On 10 June, Avita announced that its ReCell spray-on skin had been approved for pediatric patients and larger burn areas. (Avitas ReCell Wins FDA Approval For Pediatric Burn Patients)

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