# 804 First-in-Human Xenotransplantation US-FDA-Clinical Trials - Complete Wound Closure of Mixed-Depth Burns via Porcine Skin Xenotransplant

## TL;DR

This paper reports on a clinical trial using genetically modified pig skin to treat mixed-depth burns, achieving complete wound closure without adverse events.

## Contribution

The first-in-human FDA-approved xenotransplant trial for burn treatment using live porcine skin xenotransplants.

## Key findings

- Complete and durable wound closure was achieved in all patients treated with porcine skin xenotransplants.
- No adverse events or xeno-related pathologies were observed in the trial.
- Three patients did not require autografting after treatment with the xenotransplant.

## Abstract

Currently there is no treatment than can provide complete and durable wound closure of mixed-depth burn injuries, other than intact human skin, which has several drawbacks. An alternative would be a significant advancement in burn care and a meaningful benefit to patient care.

We report here the results of the first-in-human, US-FDA xenotransplantation clinical trial: the use of skin xenotransplants containing live (i.e., non-terminally sterilized, non-xenograft) epidermal and dermal tissues derived from genetically altered, pathogen-free porcine donors to provide complete and durable wound closure of mixed-depth burn wounds.

22 patients with mixed-depth burn wounds were enrolled in Phase 1/2/2b US-FDA clinical trials to evaluate the safety and efficacy of skin xenotransplants to provide complete and durable wound closure in a side-by-side comparison with human allograft.

To date, there have been zero adverse events including any xeno-related pathologies. In all patients, complete and durable wound closure was demonstrated at all xeno-treatment sites. In 3 cases, mixed-depth burns treated with the skin xenotransplant did not require autografting.

These clinical data demonstrate the ability of a live, genetically altered skin xenotransplant to facilitate complete and durable wound closure in mixed-depth burn wounds, and that the use of skin xenotransplants may potentially reduce the need for autografting in the treatment of mixed-depth burns. These claims will be evaluated in a US-FDA Phase 3 clinical trial.

First-in-Human Xenotransplant; Complete, Durable Wound Closure of Mixed, Depth, Full-Thickness Burn Wounds.