A Randomized Phase 2 Clinical Trial to Evaluate a Temporary Skin Substitute (Spincare™ Matrix) for Wound Healing in Patients with Recessive Dystrophic Epidermolysis Bullosa (RDEB)
Fellow
Piru Pathmarajah, MD
Stanford School of Medicine
Mentor
Dawn Siegel, MD
Stanford University
Overview
Recessive dystrophic epidermolysis bullosa (RDEB) is a subtype of epidermolysis bullosa (EB), a rare, inherited skin disorder. Large, painful wounds are the hallmark of this condition, requiring frequent extensive full-body dressing changes that take several hours to perform and impact the child’s quality of life. The Spincare device is the first portable tool that delivers a fine mesh to wounds to promote healing that is approved in Europe. The aim of this study is to determine the suitability of this device in RDEB wounds and assess safety, tolerability, and efficacy. This will be assessed through a mixture of in-clinic visits and remote home visits to determine the extent of wound healing and reduction of pain and itch through quality-of-life surveys. We anticipate that the results of this study will aid in future research to demonstrate that the spray device is effective and safe for delivering gene-corrected cells into RDEB wounds.
Status
This project was funded through a 2023 PeDRA Research Fellowship Grant.
