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NCT03857841 · ClinicalTrials.gov registry record · Phase 1
A Safety Study of IV Stem Cell-derived Extracellular Vesicles (UNEX-42) in Preterm Neonates at High Risk for BPD
A Phase 1 study, sponsored by United Therapeutics.
- Terminated
- Registry status
- Phase 1
- Development phase
- 3
- Enrollment target
NCT03857841: Clinical Trial Phase 1 study, sponsored by United Therapeutics.
NCT03857841 is a Phase 1 study that was terminated before completion, run by United Therapeutics. The registered enrollment target is 3 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03857841, a Phase 1 study, was terminated before completion, sponsored by United Therapeutics.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 3 participants
- Enrollment target
Study Summary
A multicenter, placebo-controlled, randomized, dose escalation, safety, and tolerability study of UNEX-42 in infants born at \<27 weeks of gestational age (GA) at high risk for bronchopulmonary dysplasia (BPD).
Primary Outcome
The safety and tolerability of UNEX-42 in subjects with BPD was evaluated by the number of subjects with treatment-emergent adverse events, including death, computed by dose cohort and overall during the Post-treatment Phase.
Interventions
- BIOLOGICAL UNEX-42
- BIOLOGICAL Phosphate-buffered saline
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2019-10-09 |
| Est. Completion | 2021-05-20 |
| Phase | Phase 1 |
Why NCT03857841 stopped before completion
NCT03857841 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 3 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 2 interventions - of which UNEX-42 is the first listed.
NCT03857841 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03857841 about?
NCT03857841 is a clinical study titled "A Safety Study of IV Stem Cell-derived Extracellular Vesicles (UNEX-42) in Preterm Neonates at High Risk for BPD". A multicenter, placebo-controlled, randomized, dose escalation, safety, and tolerability study of UNEX-42 in infants born at \<27 weeks of gestational age (GA) at high risk for bronchopulmonary dysplasia (BPD).
What is the current status of trial NCT03857841?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 3 participants. The study started on 2019-10-09. Estimated completion is 2021-05-20.
What interventions are being tested in trial NCT03857841?
The interventions under investigation include: UNEX-42 (BIOLOGICAL), Phosphate-buffered saline (BIOLOGICAL).
Who is sponsoring clinical trial NCT03857841?
This trial is sponsored by United Therapeutics, which has 63 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03857841's enrollment target sits among peer trials
3 1999th of 2000 higher than 1 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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