drugset / Trial / NCT05464381

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

NCT05464381 ↗

Phase 3 Active not recruiting 91 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
2023-06-13
Primary completion
2025-08-29
Completion
2027-01

Drugs

EvaluationDrugModalityDoseRoute
Subject allo-APZ2-OTS Cell therapy — Intravenous

Indications