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NCT05838092 · ClinicalTrials.gov registry record · Phase 3
Allogeneic ABCB5-positive Dermal Mesenchymal Stromal Cells for Treatment of Epidermolysis Bullosa (Phase III)
A Phase 3 study of Epidermolysis Bullosa, sponsored by RHEACELL GmbH & Co. KG.
- Active
- Registry status
- Phase 3
- Development phase
- 9
- Enrollment target
- 2
- Study locations
NCT05838092 is a Phase 3 study of Epidermolysis Bullosa that is active but no longer recruiting, run by RHEACELL GmbH & Co. KG. The registered enrollment target is 9 participants, below the 19-participant average among 10 other Epidermolysis Bullosa trials with a reported enrollment target (53% lower). The trial reports 2 study locations across 2 states.
The verdict
NCT05838092, a Phase 3 study of Epidermolysis Bullosa, is active but no longer recruiting, sponsored by RHEACELL GmbH & Co. KG.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 9 participants
- Enrollment target
- 2
- Study locations
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.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG allo-APZ2-OTS
Study Locations (2)
Colorado
- Children's Hospital Colorado - Aurora
Minnesota
- Masonic Cancer Center and Medical Center Minneapolis - Minneapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9 participants |
| Start Date | 2023-10-18 |
| Est. Completion | 2026-07 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05838092
The ClinicalTrials.gov registry entry for NCT05838092 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 9 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 19-participant average among 10 other Epidermolysis Bullosa trials with a reported enrollment target (53% lower). The listed sponsor is RHEACELL GmbH & Co. KG, which has 3 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Epidermolysis Bullosa appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT05838092 reports 2 study locations spanning 2 distinct geographic areas - top geographies include Colorado, Minnesota.
Frequently Asked Questions
What is clinical trial NCT05838092 about?
NCT05838092 is a clinical study titled "Allogeneic ABCB5-positive Dermal Mesenchymal Stromal Cells for Treatment of Epidermolysis Bullosa (Phase III)". 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...
What is the current status of trial NCT05838092?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 9 participants. The study started on 2023-10-18. Estimated completion is 2026-07.
What conditions does trial NCT05838092 study?
This clinical trial studies the following conditions: Epidermolysis Bullosa.
What interventions are being tested in trial NCT05838092?
The interventions under investigation include: Placebo (DRUG), allo-APZ2-OTS (DRUG).
Who is sponsoring clinical trial NCT05838092?
This trial is sponsored by RHEACELL GmbH & Co. KG, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05838092 being conducted?
This trial has 2 study locations across Colorado, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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