Allogeneic ABCB5-positive Dermal Mesenchymal Stromal Cells for Treatment of Epidermolysis Bullosa (Phase III, Cross-over)
Condition(s) studied
Investigational drug(s) / intervention(s)
allo-APZ2-OTS: Allogeneic dermal ABCB5-positive Mesenchymal Stromal Cells (ABCB5+ MSCs)
Placebo: Placebo
Study 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.
Eligibility
Primary outcome measure(s)
- Proportion of subjects with complete target wound closure — 6 months
Proportion of subjects with complete healing of target wound, determined by the investigator, as compared to baseline
Trial sites (16)
| Facility | City | Region | Status |
|---|---|---|---|
| Sanatorio Mater Dei | Buenos Aires | Argentina | |
| EB-Haus Austria; Salzburger Landeskliniken (SALK) | Salzburg | Austria | |
| Fundacion Debra Chile | Santiago | Chile | |
| Universitaetsklinik fuer Dermatologie und Allergologie | Nice | France | |
| Hospital Necker-Enfants Malades | Paris | France | |
| Service de Dermatologie Hospital Saint-Louis | Paris | France | |
| Andreas Syggros Hospital of Cutaneous Venereal Diseases | Athens | Greece | |
| Venereal & Skin Diseases Hospital of Thessaloniki | Thessaloniki | Greece | |
| Semmelweis Egyetem | Budapest | Hungary | |
| UOSD Pediatria-Alta Intensita di Curà, Ospedale Maggiore | Milan | Italy | |
| Ospedale Pediatrico Bambin Gesu | Roma | Italy | |
| Medical Concierge Centrum Medyczne | Warsaw | Poland | |
| Centro Hospitalar e Universitario de Comibra HUC | Coimbra | Portugal | |
| Hospital La Paz | Madrid | Spain | |
| Department of Dermatology, National Cheng Kung University | Tainan | Taiwan | |
| Great Ormond Street Hospital (GOSH) | London | United Kingdom |
More RHEACELL GmbH & Co. KG trials in France
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05464381 on ClinicalTrials.gov ↗ ← All trials in France