drugset / Trial / NCT05838092

Allogeneic ABCB5-positive Dermal Mesenchymal Stromal Cells for Treatment of Epidermolysis Bullosa (Phase III)

NCT05838092 ↗

Phase 3 Active not recruiting 9 enrolled RHEACELL GmbH & Co. KG
RandomizedCrossoverQuadruple-blindTreatment

Summary

The aim of this clinical trial is to investigate the safety and efficacy of allo-APZ2-OTS administered intravenously to subjects with recessive dystrophic epidermolysis bullosa (RDEB) compared to placebo. An additional baseline-controlled open-label arm will be included to investigate the safety and efficacy of allo-APZ2-OTS administered intravenously to subjects with JEB and to RDEB subjects \< 1 year.

Timeline

Start
2023-10-18
Primary completion
2025-08-29
Completion
2026-07

Drugs

EvaluationDrugModalityDoseRoute
Subject allo-APZ2-OTS Cell therapy — Intravenous

Indications