Trials / Active Not Recruiting
Active Not RecruitingNCT05838092
Allogeneic ABCB5-positive Dermal Mesenchymal Stromal Cells for Treatment of Epidermolysis Bullosa (Phase III)
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)
- Status
- Active Not Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 9 (actual)
- Sponsor
- RHEACELL GmbH & Co. KG · Industry
- Sex
- All
- Age
- 6 Months
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | allo-APZ2-OTS | Allogeneic dermal ABCB5-positive Mesenchymal Stromal Cells (ABCB5+ MSCs) |
| DRUG | Placebo | Placebo |
Timeline
- Start date
- 2023-10-18
- Primary completion
- 2025-08-29
- Completion
- 2026-07-01
- First posted
- 2023-05-01
- Last updated
- 2025-12-10
Locations
2 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05838092. Inclusion in this directory is not an endorsement.