Engineering full-thickness skin for burn wound closure – upscaling for a phase I feasibility study


Carlos Luis Arellano1,2, Ilia Banakh1,2, Mostafizur Rahman1,2, Cheng Hean Lo2,3, Heather Cleland2,3, Shiva Akbarzadeh1,2,3,
1Skin Bioengineering Laboratory, Victorian Adult Burns Service, The Alfred, Melbourne, VIC, Australia
2Department of Surgery, Monash University, Melbourne, VIC, Australia
3Victorian Adult Burns Service, The Alfred, VIC, Australia

Abstract

Introduction: The treatment of patients with severe burn wounds covering a large total body surface area (TBSA) presents a challenge due to a lack of autograft donor sites. The Skin Bioengineering Lab has developed an autologous, full-thickness, three-dimensional Human Skin Equivalent (HSE) to address this critical issue. A feasibility study in the form of a phase I clinical trial will take place at Alfred Health over the next two years to evaluate the safety and efficacy of this novel skin graft.

Methods: A small biopsy will be obtained from patients of 18-70 years of age suffering from deep burn injuries of >20% TBSA. Fibroblasts and keratinocytes will then be expanded using previously established methods. The cells will then be seeded into a platelet-rich hydrogel sheet. Ten patients will receive HSE grafts over the course of 24 months (2023-2025). Primary endpoints include the incidence of adverse device effects (ADEs) and the percentage take rate.

Results & Discussion: The graft exhibits characteristics of native skin, including the presence of a stratified epidermal layer and a fibroblast-infiltrated dermis. The current process of manufacturing HSEs has now successfully been upscaled wherein a minimum of nine 12 x 12 cm grafts can be prepared within a span of four weeks. Limiting the size of the donor site, using fully autologous cells, and fitting the graft manufacturing process within a four-week window allows for HSEs to potentially replace the need for traditional split skin grafting.

Biography

Carlos Arellano is a Research Scientist in the Skin Bioengineering Lab at the Victorian Adult Burns Service, Alfred Health. He obtained his PhD from the Monash Institute of Pharmaceutical Sciences in 2022 and has 5 years of experience in the development of drug delivery systems. He is currently responsible for developing and upscaling protocols for manufacturing bioengineered Human Skin Equivalents (HSEs) in preparation for an upcoming phase I clinical trial (2023-2026).