The U.S. Food and Drug Administration (FDA) has approved StrataGraft as a treatment for adult patients with thermal burns containing intact dermal elements for which surgical intervention is clinically indicated.
Typically, thermal burns are treated by autograft which often leaves a new wound where the healthy skin was removed.
StrataGraft is produced from keratinocytes and dermal fibroblasts grown together to make a cellularized scaffold. StrataGraft is placed onto the burn and over time, the patient’s skin cells grow over the burnt area. Treatment with StrataGraft can therefore help avoid or decrease the amount of healthy skin needed for grafting.
The FDA approval was largely based on two randomized clinical studies (NCT03005106 and NCT01437852) 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. Further details on the efficacy are currently not available. Regarding safety, common adverse effects with StrataGraft in clinical studies were pruritus, blisters, hypertrophic scar, and impaired healing at the treatment site.
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