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NCT05078385 · ClinicalTrials.gov registry record · Phase 1
Safety of Extracellular Vesicles for Burn Wounds
A Phase 1 study of Burns, sponsored by Aegle Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 1
- Enrollment target
- 2
- Study locations
NCT05078385: Completed Phase 1 study of Burns, sponsored by Aegle Therapeutics.
NCT05078385 is a Phase 1 study of Burns that has completed, run by Aegle Therapeutics. The registered enrollment target is 1 participants, below the 83-participant average among 36 other Burns trials with a reported enrollment target (99% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05078385, a Phase 1 study of Burns, has completed, sponsored by Aegle Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 1 participants
- Enrollment target
- 2
- Study locations
Study Summary
Treatment of patients with deep second degree burns of the skin with extracellular vesicles (EV) isolated from bone marrow derived mesenchymal stem cells.
Primary Outcome
Examine the safety of applying up to three applications of EVs to deep 2nd degree burn wounds up to 600 cm2 by evaluating the number of participants with treatment-related adverse events as assessed cy CTCAE v4.0
Conditions Studied
Interventions
- DRUG AGLE-102
Study Locations (2)
Florida
- Ryder Trauma Center - Miami
North Carolina
- North Carolina Jaycee Burn Center - Chapel Hill
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1 participants |
| Start Date | 2023-08-10 |
| Est. Completion | 2024-11-19 |
| Phase | Phase 1 |
What the finished NCT05078385 record still lists
NCT05078385 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 1 participants, a relatively small participant target, below the 83-participant average among 36 other Burns trials with a reported enrollment target (99% lower).
The record links to 1 condition, with Burns appearing as the primary indexed condition, and to 1 intervention - of which AGLE-102 is the first listed.
NCT05078385 reports a single indexed study location in Florida, North Carolina.
Frequently Asked Questions
What is clinical trial NCT05078385 about?
NCT05078385 is a clinical study titled "Safety of Extracellular Vesicles for Burn Wounds". Treatment of patients with deep second degree burns of the skin with extracellular vesicles (EV) isolated from bone marrow derived mesenchymal stem cells.
What is the current status of trial NCT05078385?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 1 participants. The study started on 2023-08-10. Estimated completion is 2024-11-19.
What conditions does trial NCT05078385 study?
This clinical trial studies the following conditions: Burns.
What interventions are being tested in trial NCT05078385?
The interventions under investigation include: AGLE-102 (DRUG).
Who is sponsoring clinical trial NCT05078385?
This trial is sponsored by Aegle Therapeutics, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05078385 being conducted?
This trial has 2 study locations across Florida, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Burns
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05078385's enrollment target sits among peer trials
1 36th of 36 the lowest of 36 other Burns trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Burns 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
-
StrataGraft® Skin Tissue as an Alternative to Autografting Deep Partial-Thickness Burns
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-
Patient-Controlled Anxiolysis With Dexmedetomidine (PCA-DEX) for Burn-care Dressing Changes
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Suprathel® Use During Prolonged Field Care to Promote Healing and Reduce the Need for Grafting of Burn Wounds
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Liposomal Bupivacaine Versus Lidocaine for Skin Graft Donor Site Pain
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Pilot Study: KeraStat® Gel for Topical Delivery of Morphine for Management of Non-Healing, Painful Open Wounds and Ulcers
RECRUITING · Phase 4
-
Burn Study- Tranexamic Acid Versus Thrombin in Split Thickness Skin Graft
RECRUITING · Phase 4
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