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StrataGraft (allogeneic cultured keratinocytes and dermal fibroblasts in murine collagen-dsat) is a bioengineered, allogeneic cellularized skin substitute developed by Stratatech, a subsidiary of Mallinckrodt Pharmaceuticals. It is designed as a living tissue construct to treat severe burns, specifically deep partial-thickness thermal burns, by providing a scaffold and active biological components that promote wound closure and reduce the need for autografting (harvesting the patient's own healthy skin). The product consists of two layers: a dermal-like layer containing human dermal fibroblasts and an epidermal-like layer containing human keratinocytes, both seeded onto a scaffold of murine Type I collagen. StrataGraft was approved by the FDA in June 2021 for the treatment of adult patients with deep partial-thickness burns and has been developed with significant support from the Biomedical Advanced Research and Development Authority (BARDA) as a medical countermeasure for mass casualty events.
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