Clinical trial
Allogeneic ABCB5-positive Dermal Mesenchymal Stromal Cells for Treatment of Epidermolysis Bullosa (Phase III)
Allogeneic ABCB5-positive Dermal Mesenchymal Stromal Cells for Treatment of Epidermolysis Bullosa (Phase III)
ClinicalTrials.gov ID: NCT05838092
Sponsor: RHEACELL GmbH & Co. KG
Information provided by: RHEACELL GmbH & Co. KG (Responsible Party)
Last Update Posted: 2023-10-30
Brief 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.
Official Title:
A Double-blind, Randomized, Placebo-controlled, Interventional, Multicenter, Phase III Clinical Trial to Investigate the Safety and Efficacy of ABCB5-positive Mesenchymal Stromal Cells (ABCB5+ MSCs) on Epidermolysis Bullosa (EB)
Intervention / Treatment:
- Drug: allo-APZ2-OTS
- Drug: Placebo
| Category | Value |
|---|---|
| Study Start (Actual) |
2023-10-18
|
| Primary Completion (Estimated) |
2024-12-01
|
| Study Completion (Estimated) |
2025-12-01
|
| Enrollment (Estimated) | 75 |
| Study Type | Interventional |
| Phase | Phase 3 |
| Other Study ID Numbers |
allo-APZ2-EB-III-01
|