Burn wounds and scar contractures are a significant problem for both military and civilian populations. In 2015, nearly 500,000 burn injuries were suffered in America; 40,000 required hospitalization. Over 120,000 children receive care in emergency departments for burn-related injuries each year (American Burn Association, 2016).
In both partial- and full-thickness burns, the natural integrity of the skin is breached, resulting in open wounds that reduce or eliminate the functional ability of the skin to perform its vital function as a barrier against the external world. For burns covering a large surface area, fluid, electrolyte, and temperature homeostasis is disrupted. Such disruptions to the skin, which is considered the human body’s largest organ, can be life-threatening. Thus, restoring this physiologic barrier is imperative (Herndon, 2012).
PHASE I CLINICAL TRIAL
realSKIN™ is a live biotherapeutic, split-thickness, xenotransplantation skin product derived from specialized, genetically engineered (alpha 1,3 galactosyltransferase knockout [GalT-KO]), Designated Pathogen Free (DPF), porcine donors containing live (i.e., non-terminally sterilized) porcine cells, including endothelial cells of intact vasculature and those comprising the dermal and epidermal tissue layers.
realSKIN™ provides a temporary barrier against infection, helps prevent fluid loss, and helps restore the epidermal barrier prior to definitive wound closure with the placement of an autograft. realSKIN™’s inclusion of viable epithelial, epidermal, and porcine dermal cells permit revascularization of the wound bed, critical for efficient re-epithelialization and wound healing.
In our open-label, two-cohort, 3x3 dose-escalation clinical trial (XENO-001, NCT03695939) conducted at Massachusetts General Hospital, realSKIN™ was shown to provide the same temporary wound closure and temporary restoration of barrier function as the current standard of care in the treatment of severe and extensive deep-partial and full-thickness burn wounds requiring hospitalization, surgical excision, and skin grafting.
Over the two-year study period, realSKIN™ has demonstrated safety and tolerability in all patients treated, and its efficacy is indistinguishable from that of the Human Cadaver Allograft (HCA) active control.