Study of AGLE-102 Mesenchymal Stem Cell Vesicles to Treat Persistent Wounds in Recessive Dystrophic Epidermolysis Bullosa

What this Trial Is About

Researchers are evaluating AGLE-102, an investigational product made of extracellular vesicles derived from donor mesenchymal stem cells, for treating wounds in people with Dystrophic Epidermolysis Bullosa DEB, a condition causing persistent skin wounds. This phase 12A randomized, multi-center study aims to assess the safety and initial effectiveness of AGLE-102 on wounds that have lasted at least four weeks in DEB patients. Participants with two similar wounds each between 10 and 50 cm2 are enrolled, with one wound randomly assigned to receive up to six topical administrations of AGLE-102 approximately every two weeks over 10 weeks alongside standard wound care. The other wound receives standard care alone. After treatment, wounds are monitored every four weeks for 12 weeks to assess healing and scar quality, with no influence on treatment schedules based on control wound status. Participants undergo regular evaluations including wound healing assessments, safety monitoring for adverse events over 22 weeks, and measures of pain relief and quality of life. Wound closure is confirmed by complete re-epithelialization without re-injury. The study involves informed consent and follow-up visits to verify wound status and scar improvements, with an enrollment target of eight subjects.

MSC EVs in Dystrophic Epidermolysis Bullosa