Evaluation of Safety and Efficacy of realSKIN® (Skin Xenotransplant) for Complete Closure of Severe Burn Wounds

Product Name: realSKIN® Chemical Name: alpha-1,3-galactosyltransferase knock-out (GalT-KO) porcine (Sus scrofa) epidermal and dermal layers. Chemical Structure: realSKIN® a biologically active, split-thickness, xenotransplantation skin product. realSKIN® is derived from specialized, genetically engineered (alpha 1,3 galactosyltransferase knockout \[GalT-KO\]), Designated Pathogen Free (DPF), porcine donors, containing vital, metabolically active (i.e., non-terminally sterilized) porcine cells within the dermal and epidermal tissue layers. Proposed Indication: realSKIN is indicated for the treatment of mixed-depth, full-thickness burn wounds requiring hospitalization, surgical excision, and skin grafting. Drug Type: realSKIN® is classified as a Live Biotherapeutic Product (LBP). (Guidance to Industry, Early Clinical Trials with Live Biotherapeutic Products, Section 1.b.) Active Ingredient: Live (i.e. non-terminally sterilized) porcine cells, including endothelial cells of intact vasculature and those comprising the dermal and epidermal tissue layers Product Structure: realSKIN® has an approximate thickness of 0.022 inches (0.55mm) and is currently provided in one investigational size: approximately 5x15 cm2 (22.5g/75 cm2). Formulation: Each lot or releasable batch of realSKIN® is derived from a single source animal and each batch is independently processed and tested for various adventitious agents, histology, morphology, sterility, and purity. Route of Administration: Surgical engraftment, via sutures or staples Dosing Regimen: A single topical application of realSKIN has an approximate size of 150 cm2, with dimensions of 5 cm x 15 cm, meshed in a 2:1 ratio, and has an approximate thickness of 0.022 inches (0.55 mm). realSKIN is intended for a one-time, topical application to a surgically prepared wound bed via sutures or staples and may be trimmed to fit the shape and size of the actual wound area. realSKIN can be used in the treatment of an overall injury size of up to 30% TBSA burn injury. Drug's Mechanism of Action: realSKIN is intended for topical use directly on debrided, severe and extensive, mixed-depth and full-thickness burn wounds to provide complete and durable wound closure. As a living skin transplant, realSKIN forms microvascular connections with host vessels in the burn wound bed which leads to wound closure. realSKIN replaces elements of whole, living skin that are analogous and functionally equivalent to those found in healthy human skin. realSKIN does not remain permanently engrafted but is replaced by the patient's own cells over time. This mechanism of action distinguishes realSKIN from traditional xenograft products which are terminally sterilized, rendering the cells inactive, limiting their therapeutic capability to effect complete and durable wound closure. Drug Packaging: Each realSKIN® product is individually packaged in a clear plastic, externally threaded, 10-ml polypropylene vial with threaded seal-cap, stored on a rolled, sterile nylon mesh backing on the dermal-side of the realSKIN® product that serves to support and protect the graft during processing and transport. Within this container, each realSKIN® product is individually immersed in 7-ml of sterile cryoprotective medium with 5% dimethyl sulfoxide (DMSO) (CryoStor CS5, BioLifeSolutions). Source animal serum is NOT included or used in this process. The contents are cryopreserved via controlled rate, phase freezer and stored at -80o C until use. All packaging materials are removed prior to the surgical procedure and dressing placement.