Skin Substitute Technology for Chimeric Autologous/Allogeneic Constructs for Skin Regeneration - Preclinical Studies

Complex skin defects, including burns and trauma, represent a major medical problem affecting both military and civilian populations. In recent military engagements, burns account for approximately 5% of combat casualties. Furthermore, approximately 1.25 million Americans each year require medical attention for complex skin defects, with 50,000 people hospitalized for burns and 13,000 requiring skin grafts. With severe skin injuries, disruption of the epidermal permeability barrier and skin loss must be addressed promptly to prevent life-threatening complications. However, restoration of fully functional skin requires regeneration of the interfollicular epidermis, the cutaneous appendages, and the underlying vascularized dermis. Currently, no therapeutic approach addresses both the immediate need for wound coverage and the ultimate goal of autologous skin tissue regeneration. To address this unmet need, we have proposed a therapeutic approach which combines the advantages of a next generation bioengineered skin substitute with the benefits of autologous tissue micrografting to 1) recapitulate the normal barrier function of intact human skin, 2) reduce time to wound closure, 3) speed wound revascularization, and 4) deliver autologous tissue for skin regeneration with functional and cosmetic restoration. To make this treatment option availability to patients, independent clinical evaluation and FDA approval are required to commercialize these technologies.