FDA clears first xenotransplantation trial of skin cells derived from genetically engineered pigs

The FDA has cleared XenoTherapeutics to begin a first-of-its-kind human clinical trial that uses topically applied live skin cells derived from genetically engineered pigs as a treatment for severe burns.

The biologically active Xeno-Skin product consists of dermal and epidermal tissue layers, sterilized and sourced from animals designed to be free of the viral pathogens that have been an obstacle to the use of porcine xenotransplants in the past, the company said.

The transplanted skin aims to provide temporary coverage as an immediate treatment option for patients with extensive deep-partial and full-thickness burn wounds. XenoTherapeutics is preparing to enroll patients at Massachusetts General Hospital by the end of the year.

"Xeno-Skin is the first non-human organ transplant cleared by the FDA for investigational use," said Paul Holzer, CEO and co-founder of XenoTherapeutics.

"Our goal with this initial product is to advance the science of xenotransplantation for practical therapies that can benefit patients around the globe while addressing a critically unmet need for burns; but equally as important, paving the way for future organ transplant solutions," Holzer said.

Patients with severe burns are at increased risk of infection and fluid loss, which can contribute to electrolyte, temperature and pH imbalances that can lead to organ failure. Xeno-Skin is intended to replace or complement a deceased donor allograft—the current standard-of-care, though only available in limited quantities. Xeno-Skin, however, is designed to be mass-produced, stored and shipped where needed, the company said.

"Ultimately, having a temporary skin barrier solution that can be cryopreserved and shipped globally for immediate use or storage will help increase emergency preparedness for unexpected catastrophic events and fill current shortages experienced far too frequently around the world today," said XenoTherapeutics Chief Medical Officer Curtis Cetrulo, who also serves as a transplant surgeon at MGH.

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