An Antimicrobial Dermal Regeneration Template for application in challenging wound environments

Fesariustherapeutics, Inc., New York NY

Investigators

Abstract

PROJECT SUMMARY/ABSTRACT Successful and definitive closure of a wound is often jeopardized by microbial contamination or even colonization, particularly in patients requiring surgical treatment of traumatic injury. The risk of infection is increased due to potential exposure of critical structures like tendons, ligaments, and bone, which can quickly deteriorate without adequate coverage. Traditional treatments and wound care devices may be limited by the need for specific handling or storage conditions, which can be challenging to maintain in dynamic or resource- constrained environments. These factors underscore the urgent need for innovative, readily accessible wound treatment solutions that can stabilize injuries, prevent infection and moisture loss, and enhance recovery outcomes in patients awaiting comprehensive surgical care. Conventional wound dressings, including antimicrobial products such as silver containing fabric dressings, may reduce bacterial burden, but concerns regarding cytotoxicity, delayed wound healing and inconsistent antimicrobial performance have limited their clinical benefit. Even when these dressings “work” as intended, they do not directly contribute to wound closure. Although tissue-engineered viable cell grafts like Apligraf® and Dermagraft® and dermal regeneration scaffolds (DRS) such as Integra® Bilayer Matrix can provide wound coverage and directly contribute to definitive wound closure, they will inevitably fail when placed in even minimally contaminated wounds. Our current proposal aims to address these challenges by developing DermiSphereTM Shield, an antimicrobial dermal template tailored for wound healing in a potentially contaminated environment. This template will induce rapid and robust cellular infiltration and promote angiogenesis, essential for neodermis formation and wound healing, and incorporate antimicrobial properties to combat infection. Because DermiSphere Shield™ will contain a broad spectrum non-molecular antimicrobial and becomes vascularized within days, the device is rapidly transformed into living tissue, protected by the patient’s own immune system, rendering it much more resistant to infection, even in suboptimal wound scenarios. The overall goal of this SBIR Phase I proposal is to demonstrate feasibility of DermiSphere Shield as a device for the management of suboptimal (i.e. contaminated or prone to infection) wounds achieved by regeneration of a functional, stable, vascularized neo-dermis. We will accomplish this by 1) developing 3 lead formulation prototypes that maximize antimicrobial properties of the prototype while minimizing its effects on mechanical properties and cytotoxicity; 2) confirming the unimpaired ability of the antimicrobial prototypes to promote tissue regeneration in clean wounds in vivo; and 3) demonstrate the efficacy of the best formulation in a contaminated, clinically relevant swine model. The commercialization of DermiSphereTM Shield is expected to improve clinical practice in the fields where treatment of contaminated or potentially contaminated wounds (for example burn wounds, diabetic foot ulcers) is common by significantly decreasing the time and number of procedures required to achieve a healed wound.