FDA Approves StrataGraft for the Treatment of Adults with Thermal Burns
StrataGraft is produced from keratinocytes and dermal fibroblasts grown together to make a bi-layered construct or a cellularized scaffold.
The U.S. Food and Drug Administration approved StrataGraft for the treatment of adult deep partial thickness burns.
"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," says Peter Marks, MD, PhD, director of FDA's Center for Biologics Evaluation and Research, in a news release. "This approval provides health care professionals a novel way to treat burn wounds."
For many deep burns, treatment frequently involves the removal of the damaged, burned skin and replacement with a skin graft, which leaves a new wound where the healthy skin was removed.
StrataGraft is produced from keratinocytes and dermal fibroblasts grown together to make a bi-layered construct or a cellularized scaffold.
StrataGraft is for topical application, placed onto the burn by a healthcare provider. Over time, the patient's skin cells should grow to replace the skin cells lost as a result of the burn. Treatment with StrataGraft can help avoid or decrease the amount of healthy skin that is needed for grafting.
The effectiveness and safety of StrataGraft is based on two randomized clinical studies involving a total of 101 adult patients with deep partial–thickness thermal burns. In both studies, two deep partial-thickness burn wounds of comparable area and depth on each patient were identified and randomized to receive either a single topical application of StrataGraft or autograft. The effectiveness is demonstrated by the percentage of StrataGraft treatment sites that achieved a complete wound closure, and the significantly decreased need for autografts at the StrataGraft treatment sites.
Common side effects reported by patients who received StrataGraft in clinical studies were pruritus, blisters, hypertrophic scar, and impaired healing (stalled healing process) at the treatment site. Overall, the safety profile of StrataGraft regarding wound–related events, included erythema, swelling, local warmth and wound site infections, was similar to that of autografting in these studies. There were no reports of rejection of StrataGraft in the clinical studies.
The FDA granted StrataGraft regenerative medicine advanced therapy (RMAT), Priority Review and Orphan Drug designations for this indication.
StrataGraft was developed in conjunction with the U.S. Department of Health and Human Services' Biomedical Advanced Research and Development Authority.
Since the human keratinocyte cells were grown with mouse cells during initial stages of product development, StrataGraft is formally considered to be a xenotransplantation product. Mouse cells are no longer used in the final manufacturing process. Due to StrataGraft containing cells from human donors and animal-derived materials, and because animal cells were used in early stages of product development, there is a risk of transmission of infectious diseases or agents although at this time transmission of infectious diseases or agents by StrataGraft has not been reported.
The FDA granted approval to Stratatech, a Mallinckrodt company.