Safety and Effectiveness of Ev.FV Treatment for Wound Healing in Children and Young Adults with Dystrophic Epidermolysis Bullosa

What this Trial Is About

Dystrophic Epidermolysis Bullosa DEB is a rare genetic skin disease causing fragile skin that blisters and bleeds easily, with severity ranging from mild to life-threatening. It results from mutations affecting collagen VII, which is essential for skin integrity. This trial evaluates the safety and effectiveness of a new cell-free therapy called Ev.FV, derived from mesenchymal stem cell extracellular vesicles, aiming to promote wound healing and skin regeneration in DEB patients. Participants will receive Ev.FV, a biological product containing five factors, through intravenous doses given six times every two weeks. These nanovesicles carry molecules that can reduce inflammation, stimulate skin cell growth, promote blood vessel formation, and potentially repair the skins anchoring structures. The study focuses on patients with chronic wounds sized between 10 and 50 square centimeters and includes assessments over several months to monitor wound healing and skin condition. During the trial, patients will undergo evaluations including wound closure rates measured at day 14, and skin disease activity scores at multiple time points up to six months. Pain levels will also be tracked using a visual scale over 30 days. Researchers will monitor safety, treatment effects, and how well the wounds heal. The total study duration includes follow-up visits to ensure comprehensive observation of the therapys impact.

Effect of Ev.FV on Wound Healing in Dystrophic Epidermolysis Bullosa