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.

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.