| Definition | Stratagraft (allogeneic cultured keratinocytes and dermal fibroblasts in murine collagen-dsat) is an allogeneic cellularized scaffold product used for the treatment of adults with thermal burns containing intact dermal elements for which surgical intervention is clinically indicated (also known as deep partial-thickness burns).[L35505] It was developed as an alternative to autografting - the process by which a patient's own skin is harvested and grafted onto the burn site - which has the disadvantage of creating a new wound at the site from which the graft is taken.[L35525]
Stratagraft consists of two kinds of lab-grown skin cells, keratinocytes and dermal fibroblasts, which are grown together on a murine collagen matrix to make a bi-layered construct (i.e. a cellularized scaffold). Sheets containing this scaffold product are applied to the burn site and, as they contain metabolically active and viable cells, provide a variety of human growth factors and cytokines as well as extracellular matrix proteins, all of which are known to be involved in wound repair. The product does not remain permanently engrafted, instead being replaced by the patient's own cells over time, which can reduce or even eliminate the need for autografting.[L35505]
Stratagraft was in the early stages of development as far back as 2009[A237275] and was granted full FDA approval in June 2021.[L35525] |
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