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NCT04173650 · ClinicalTrials.gov registry record · Phase 1
MSC EVs in Dystrophic Epidermolysis Bullosa
A Phase 1 study of Dystrophic Epidermolysis Bullosa, sponsored by Aegle Therapeutics.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 8
- Enrollment target
- 3
- Study locations
NCT04173650: Recruiting Phase 1 study of Dystrophic Epidermolysis Bullosa, sponsored by Aegle Therapeutics.
NCT04173650 is a Phase 1 study of Dystrophic Epidermolysis Bullosa that is actively recruiting participants, run by Aegle Therapeutics. The registered enrollment target is 8 participants, below the 19-participant average among 7 other Dystrophic Epidermolysis Bullosa trials with a reported enrollment target (58% lower). The trial reports 3 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04173650, a Phase 1 study of Dystrophic Epidermolysis Bullosa, is actively recruiting participants, sponsored by Aegle Therapeutics.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 8 participants
- Enrollment target
- 3
- Study locations
Study Summary
INVESTIGATIONAL PRODUCT: AGLE-102 is an allogeneic extracellular vesicle (EV) product derived from normal donor mesenchymal stem cells (MSCs). INDICATION AND RATIONALE: The aim of the study is to assess the safety and efficacy of AGLE-102 in the treatment of lesions in subjects with Epidermolysis Bullosa (EB). STUDY DESIGN: This is a phase 1/2A, randomized, multi-center, study to assess the effectiveness and safety of AGLE-102 on lesions in subjects with EB.
Primary Outcome
Incidence of adverse events after single and repeat administrations of EVs
Conditions Studied
Interventions
- DRUG AGLE-102
Study Locations (3)
Arizona
- Phoenix Children's Hospital - Phoenix
California
- USC /Norris Comprehensive Cancer Center University of Southern California - Los Angeles
Pennsylvania
- Children's Hospital of Philadelphia - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2024-08-13 |
| Est. Completion | 2026-03 |
| Phase | Phase 1 |
What NCT04173650 shows while recruiting
NCT04173650 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 8 participants, a relatively small participant target, below the 19-participant average among 7 other Dystrophic Epidermolysis Bullosa trials with a reported enrollment target (58% lower).
The record links to 1 condition, with Dystrophic Epidermolysis Bullosa appearing as the primary indexed condition, and to 1 intervention - of which AGLE-102 is the first listed.
NCT04173650 reports a single indexed study location in Arizona, California, Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT04173650 about?
NCT04173650 is a clinical study titled "MSC EVs in Dystrophic Epidermolysis Bullosa". INVESTIGATIONAL PRODUCT: AGLE-102 is an allogeneic extracellular vesicle (EV) product derived from normal donor mesenchymal stem cells (MSCs). INDICATION AND RATIONALE: The aim of the study is to assess the safety and efficacy of AGLE-102 in the treatment of lesions in subjects with Epidermolysis B...
What is the current status of trial NCT04173650?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 8 participants. The study started on 2024-08-13. Estimated completion is 2026-03.
What conditions does trial NCT04173650 study?
This clinical trial studies the following conditions: Dystrophic Epidermolysis Bullosa.
What interventions are being tested in trial NCT04173650?
The interventions under investigation include: AGLE-102 (DRUG).
Who is sponsoring clinical trial NCT04173650?
This trial is sponsored by Aegle Therapeutics, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04173650 being conducted?
This trial has 3 study locations across Arizona, California, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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