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allogeneic cultured keratinocytes and dermal fibroblasts in murine collagen-dsat (Mallinckrodt Pharmaceuticals)
- Development stage
- Discontinued
- Lead developer
- StrataTech
- Modality
- Cell Therapies
- Administration
- Topical
01
Overview
SOMA Tx refers to the treatment regimen of StrataGraft (allogeneic cultured keratinocytes and dermal fibroblasts in murine collagen-dsat) overlay of meshed autograft (SOMA), which was evaluated for the treatment of full-thickness thermal burns. StrataGraft is a viable, bioengineered, allogeneic, cellularized scaffold product consisting of a fully-stratified epithelial layer of differentiated, multilayered, epidermal keratinocytes grown on a purified murine Type I collagen matrix embedded with dermal fibroblasts. Developed by Stratatech (a Mallinckrodt company), StrataGraft is FDA-approved for the treatment of adults with deep partial-thickness thermal burns. It delivers metabolically active cells that produce and secrete various growth factors and cytokines involved in wound repair and regeneration, thereby promoting durable wound closure and regenerative healing while reducing the need for autografting. The clinical development of the SOMA overlay regimen for full-thickness thermal burns was evaluated in a Phase 1/2a trial (StrataSOMA) which was subsequently terminated.
- Brand names
- StrataGraft
- Other names
- SOMASOMA TxStrataGraft Overlay of Meshed AutograftStrataGraft skin tissueallogeneic cultured keratinocytes and fibroblasts
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