Clinical Evaluation of StrataGraft Skin Tissue

DESCRIPTION (provided by applicant): Severe burns and other major trauma to the skin are life-threatening injuries that often require immediate surgical intervention. Typically, this involves temporary coverage of the wound site with cadaver skin or synthetic dressings to prevent infection and dehydration. Permanent closure of the wound is generally accomplished through split-thickness skin autografting after the wound bed has healed to the point that it will accept autograft tissue. Although this regimen is the standard of care for severe skin wounds, limited availability of cadaver skin, the potential for transmission of pathogens from donor tissue, and the ultimate rejection of the cadaver skin pose serious drawbacks to this approach. Safe and effective alternatives to the use of cadaver skin are needed to improve the care of patients with these life-threatening wounds. Stratatech Corporation has developed a novel cultured skin substitute tissue, StrataGraft(tm) skin tissue, for the temporary management of severe skin wounds prior to autografting. The development and optimization of StrataGraft(tm) tissue was funded in part by the Phase I portion of this SBIR project. StrataGraft(tm) tissue is a living combination skin substitute with a fully-stratified epidermal layer which imparts permeability barrier function comparable to that of native epidermis. The FDA has approved a Phase I/II clinical trial (IND#10113) for Stratatech to evaluate the safety and efficacy of StrataGraft(tm) skin tissue as an alternative to cadaver skin in the temporary management of severe skin defects requiring surgical intervention. This Phase II SBIR proposal is designed to build on the success of the Phase I project by performing a clinical evaluation of StrataGraft(tm) skin tissue. Successful completion of this Phase l/ll clinical trial will position Stratatech to conduct a pivotal Phase III clinical trial, leading to the ultimate commercialization of StrataGraft(tm) skin tissue as an improved therapy for the management of burns and other severe skin trauma.