PATIENTS ARE WAITING ON US
Hope has become help for our patients.
XenoTherapeutics Foundation has engineered the first and only live-cell xenotransplantation product cleared by the FDA for investigational use, advancing a promising platform of therapies from theory to clinical reality.
First Indication: Severe Burns
Severe and extensive, deep-partial and full-thickness burn wounds represent a clinically unmet need in the United States, with thousands of fatalities each year. In 2016 alone, there were 3,390 deaths from fires, with one fire death occurring every 2 hours 35 minutes. Burn injuries continue to be one of the leading causes of unintentional death and injury in the United States.
Nearly a quarter of all burn injuries are so severe that victims require intensive care at a designated burn center.
Temporary wound closure with human allograft skin is considered the gold standard after early excision of a large burn injury. Limitations of allograft include availability, cost, and safety.
Our first-in-human, Phase I clinical trial of Xeno-Skin™ is providing burn victims with the same quality and enhanced safety to human allograft skin, a valuable surgical adjunct to the clinical options currently available to treat severe and extensive full-thickness burn wounds.
Ongoing research: Xeno-Skin™
Xeno-Skin™ consists of split-thickness skin xenotransplants containing vital dermal and epidermal cells aseptically procured from alpha-galactosyltransferase knockout porcine donors from a closed, Designated Pathogen Free colony (Patent No. 10,799,614).
In 2018, the FDA authorized a first-in-human Phase I clinical trial to evaluate the safety and tolerability of a genetically modified skin xenotransplant to treat severe and extensive burn wounds.
Xeno-Skin™ provides the same quality with enhanced safety, with advantages including retention of 70% or more of the innate metabolic activity following cryopreservation, vascularly favorable dermal thickness, and genetic modifications that eliminate hyperacute graft rejection.
Combined, these result in pliability, strength, survivability, and function that far exceed those of conventional xenografts and mirror those of human allograft.
To date, Xeno-Skin™ was well tolerated by all patients, resulting in zero adverse events or safety issues, and without zoonotic disease transmission. In all cases, the skin xenotransplant appeared indistinguishable from the human allograft comparator and at the time of autografting, both were vascularized and fully adherent.
These highly promising patient outcomes demonstrate a potential treatment for complicated burns, especially when human allograft skin is unavailable.