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allogeneic cultured keratinocytes and dermal fibroblasts in murine collagen
- Development stage
- Phase 3
- Lead developer
- StrataTech
- Modality
- Implantable Hydrogels → Hydrogel Systems → Drug Delivery Systems, Implantable Devices → Device-based Delivery → Drug Delivery Systems, Recombinant Proteins and Enzymes, Stem Cell Therapies → Cell Therapies, Injectable Hydrogels → Hydrogel Systems → Drug Delivery Systems
- Administration
- Topical
01
Overview
Stratagraft is a bioengineered, bilayer human skin substitute composed of allogeneic (donor-derived) cultured keratinocytes and dermal fibroblasts embedded in a murine (mouse) collagen scaffold. It is designed to mimic natural human skin with both inner dermis-like and outer epidermis-like layers. Stratagraft delivers viable cells that produce growth factors and cytokines involved in wound repair and regeneration, supporting the body’s own healing process. The product is indicated for the treatment of adults with thermal burns containing intact dermal elements (deep partial-thickness burns) for which surgical intervention is clinically indicated. It was developed by Stratatech Corporation, now part of Mallinckrodt, with support from BARDA. The FDA approved Stratagraft as a regenerative medicine advanced therapy (RMAT), granting it orphan drug status[2][4][5][6][7].
- Brand names
- Stratagraft
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