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NCT03529877 · ClinicalTrials.gov registry record · Phase 1
Allogeneic ABCB5-positive Stem Cells for Treatment of Epidermolysis Bullosa
A Phase 1 study, sponsored by RHEACELL GmbH & Co. KG.
- Completed
- Registry status
- Phase 1
- Development phase
- 16
- Enrollment target
NCT03529877: Completed Phase 1 study, sponsored by RHEACELL GmbH & Co. KG.
NCT03529877 is a Phase 1 study that has completed, run by RHEACELL GmbH & Co. KG. The registered enrollment target is 16 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (73% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03529877, a Phase 1 study, has completed, sponsored by RHEACELL GmbH & Co. KG.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 16 participants
- Enrollment target
Study Summary
The aim of this clinical trial is to investigate the efficacy (by monitoring overall improvement of EB symptoms) and safety (by monitoring adverse events) of three doses of allo-APZ2-EB administered intravenously to patients with recessive dystrophic epidermolysis bullosa (RDEB).
Primary Outcome
EBDASI: epidermolysis bullosa disease activity and scarring index; measured in percentage change to baseline score
Interventions
- BIOLOGICAL allo-APZ2-EB
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2019-02-16 |
| Est. Completion | 2021-11-26 |
| Phase | Phase 1 |
What the finished NCT03529877 record still lists
NCT03529877 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (73% lower).
The record links to 0 conditions, and to 1 intervention - of which allo-APZ2-EB is the first listed.
NCT03529877 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03529877 about?
NCT03529877 is a clinical study titled "Allogeneic ABCB5-positive Stem Cells for Treatment of Epidermolysis Bullosa". The aim of this clinical trial is to investigate the efficacy (by monitoring overall improvement of EB symptoms) and safety (by monitoring adverse events) of three doses of allo-APZ2-EB administered intravenously to patients with recessive dystrophic epidermolysis bullosa (RDEB).
What is the current status of trial NCT03529877?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 16 participants. The study started on 2019-02-16. Estimated completion is 2021-11-26.
What interventions are being tested in trial NCT03529877?
The interventions under investigation include: allo-APZ2-EB (BIOLOGICAL).
Who is sponsoring clinical trial NCT03529877?
This trial is sponsored by RHEACELL GmbH & Co. KG, which has 3 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03529877's enrollment target sits among peer trials
16 1786th of 2000 higher than 203 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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