First Xenotransplantation Trial Of Genetically Engineered Skin Cells
XenoTherapeutics gets a green signal to FDA to conduct the world’s first human clinical trial that involves live skin cells derived from genetically engineered pigs for treatment of intense burns. As said Paul Holzer, CEO and co-founder of XenoTherapeutics, Xeno-Skin is going to be the first non-human organ transplant cleared by the FDA for investigational use.
Xeno’s biologically active skin product comprises of animal-derived dermal and epidermal tissue layers and is sterilized to be free of the viral pathogens. As per XenoTherapeutics, In the past, this used to be an obstacle for usage in porcine xenotransplants.
For patients with intense burns, this transplantation can serve as a temporary yet immediate treatment option. The process of enrolling patients at Massachusetts General Hospital is to be initiated by the end of the year after FDA cleared it for human trials.
Holzer in a statement said the company’s main motto with this product was to advance the science of xenotransplantation for practical therapies, which would benefit patients all around the globe. No immediate treatment option was available until now to meet the needs for severe burns, this revolutionary product would pave ways for further organ transplantation research, he added.
Xeno-Skin will be mass-produced, cryopreserved & shipped across the globe. Patients with intense burns risk infections & fluid loss that can lead to organ failure. With Xeno-Skin, deceased donor allograft which is available in very limited quantities can be either replaced or complemented.