drugset / Trial / NCT04173650

MSC EVs in Dystrophic Epidermolysis Bullosa

NCT04173650 ↗

Phase 1/2 Recruiting 8 enrolled Aegle Therapeutics
RandomizedSingle-groupOpen-labelTreatment

Summary

INVESTIGATIONAL PRODUCT: AGLE-102 is an allogeneic extracellular vesicle (EV) product derived from normal donor mesenchymal stem cells (MSCs). INDICATION AND RATIONALE: The aim of the study is to assess the safety and efficacy of AGLE-102 in the treatment of lesions in subjects with Epidermolysis Bullosa (EB). STUDY DESIGN: This is a phase 1/2A, randomized, multi-center, study to assess the effectiveness and safety of AGLE-102 on lesions in subjects with EB.

Timeline

Start
2024-08-13
Primary completion
2025-09
Completion
2026-03

Drugs

EvaluationDrugModalityDoseRoute
Subject AGLE-102 Other / unclassified — Topical