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Trade names | Stratagraft |
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Routes of administration | Topical |
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Allogeneic cultured keratinocytes and dermal fibroblasts in murine collagen, sold under the brand name Stratagraft, is a medical treatment used for thermal burns containing intact dermal elements. [1]
Common side effects include pruritus (itching), blisters, hypertrophic scar, and impaired healing (stalled healing process) at the treatment site. [3]
Stratagraft is produced from two kinds of human skin cells (keratinocytes and dermal fibroblasts) grown together to make a bi-layered construct (a cellularized scaffold). [3] 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 (involving tissues or cells belonging to different species). [3] Mouse cells are no longer used in the final manufacturing process. [3] It was approved for medical use in the United States in June 2021. [3]
Stratagraft (allogeneic cultured keratinocytes and dermal fibroblasts in murine collagen-dsat) is indicated for the treatment of adults with thermal burns containing intact dermal elements for which surgical intervention is clinically indicated (deep partial-thickness burns). [1]
The US Food and Drug Administration (FDA) evaluated the effectiveness and safety of Stratagraft based on two randomized clinical studies involving a total of 101 adult participants with deep partial thickness thermal burns. [3] In both studies, two deep partial-thickness burn wounds of comparable area and depth on each participant were identified and randomized to receive either a single topical application of Stratagraft or autograft. [3] 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. [3]
The FDA granted Stratagraft regenerative medicine advanced therapy, priority review, and orphan drug designations for this indication. [3] Stratagraft was developed in conjunction with the U.S. Department of Health and Human Services’ Biomedical Advanced Research and Development Authority. [3] The FDA granted approval to Stratatech, a Mallinckrodt company. [3]