Allogeneic cultured keratinocytes and dermal fibroblasts in murine collagen
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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]
Medical uses
[edit]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]
History
[edit]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]
References
[edit]- ^ a b c "Stratagraft- allogeneic cultured keratinocytes and dermal fibroblasts in murine collagen-dsat cellular sheet". DailyMed. 12 November 2021. Retrieved 20 April 2023.
- ^ "Stratagraft". U.S. Food and Drug Administration (FDA). 13 July 2021. Retrieved 20 April 2023.
- ^ a b c d e f g h i j k "FDA Approves StrataGraft for the Treatment of Adults with Thermal Burns". U.S. Food and Drug Administration (FDA) (Press release). 15 June 2021. Retrieved 20 April 2023.
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