MSC EVs in Dystrophic Epidermolysis Bullosa

This study tests a new cell-based therapy for dystrophic epidermolysis bullosa (DEB), a severe genetic skin disorder that causes the skin to blister and wound extremely easily — even from minor friction. People with DEB lack functional collagen VII, a protein that holds the skin's layers together. There is no cure, and managing wounds is a lifelong challenge. The experimental treatment, AGLE-102, uses extracellular vesicles (tiny particles released from stem cells) to promote wound healing. Participants will have two similar wounds treated — one with AGLE-102 and one with standard care — and researchers will compare how quickly each wound heals. This approach avoids some risks of cell transplantation while still delivering healing signals to damaged tissue. You may be eligible if: - You are at least 6 months old with a confirmed diagnosis of DEB (by genetic testing, electron microscopy, or immunomapping) - You have had two matching wounds (10–50 cm²) that have been open for at least 4 weeks - Females of childbearing potential must have a negative pregnancy test and use contraception - You (or your guardian) are willing to comply with study requirements You may NOT be eligible if: - You have signs of active systemic infection - You have had a bone marrow transplant - You have a diagnosed autoimmune disease or are currently taking systemic steroids or immunosuppressants - You have a current malignancy (including skin cancer) - You have a history of coagulopathy (clotting disorder) - You are allergic to human albumin, streptomycin, or penicillin - You are pregnant, nursing, or planning a pregnancy during the study - You are enrolled in another investigational drug or device study Talk to your doctor to see if this trial is right for you.