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NCT05157958 · ClinicalTrials.gov registry record · Phase 2
Study to Evaluate Safety and Efficacy of ALLO-ASC-SHEET in Subjects With Dystrophic Epidermolysis Bullosa
A Phase 2 study of Dystrophic Epidermolysis Bullosa, sponsored by Anterogen Co..
- Recruiting
- Registry status
- Phase 2
- Development phase
- 6
- Enrollment target
- 1
- Study location
NCT05157958: Recruiting Phase 2 study of Dystrophic Epidermolysis Bullosa, sponsored by Anterogen Co..
NCT05157958 is a Phase 2 study of Dystrophic Epidermolysis Bullosa that is actively recruiting participants, run by Anterogen Co.. The registered enrollment target is 6 participants, below the 20-participant average among 7 other Dystrophic Epidermolysis Bullosa trials with a reported enrollment target (70% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05157958, a Phase 2 study of Dystrophic Epidermolysis Bullosa, is actively recruiting participants, sponsored by Anterogen Co..
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 6 participants
- Enrollment target
- 1
- Study location
Study Summary
After confirming eligibility, a single subject with four selected target lesions will receive both ALLO-ASC-SHEET and Vehicle control, three target lesions for ALLO-ASC-SHEET and the other target for Vehicle control, and which lesion to apply which IP treatment will be determined randomly at the time of enrollment using pre-designed block randomization scheme.
Conditions Studied
Interventions
- OTHER Vehicle Control
- BIOLOGICAL ALLO-ASC-SHEET
Study Locations (1)
Florida
- University of Miami Dermatology Clinical Trials Unit - Miami
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2023-05-01 |
| Est. Completion | 2026-04-28 |
| Phase | Phase 2 |
What NCT05157958 shows while recruiting
NCT05157958 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 20-participant average among 7 other Dystrophic Epidermolysis Bullosa trials with a reported enrollment target (70% lower).
The record links to 1 condition, with Dystrophic Epidermolysis Bullosa appearing as the primary indexed condition, and to 2 interventions - of which Vehicle Control is the first listed.
NCT05157958 reports a single indexed study location in Florida.
Frequently Asked Questions
What is clinical trial NCT05157958 about?
NCT05157958 is a clinical study titled "Study to Evaluate Safety and Efficacy of ALLO-ASC-SHEET in Subjects With Dystrophic Epidermolysis Bullosa". After confirming eligibility, a single subject with four selected target lesions will receive both ALLO-ASC-SHEET and Vehicle control, three target lesions for ALLO-ASC-SHEET and the other target for Vehicle control, and which lesion to apply which IP treatment will be determined randomly at the tim...
What is the current status of trial NCT05157958?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 6 participants. The study started on 2023-05-01. Estimated completion is 2026-04-28.
What conditions does trial NCT05157958 study?
This clinical trial studies the following conditions: Dystrophic Epidermolysis Bullosa.
What interventions are being tested in trial NCT05157958?
The interventions under investigation include: Vehicle Control (OTHER), ALLO-ASC-SHEET (BIOLOGICAL).
Who is sponsoring clinical trial NCT05157958?
This trial is sponsored by Anterogen Co., which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05157958 being conducted?
This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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