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NCT05130983 · ClinicalTrials.gov registry record · Phase 1
Study of ExoFlo for the Treatment of Medically Refractory Crohn's Disease
A Phase 1 study, sponsored by Direct Biologics.
- Terminated
- Registry status
- Phase 1
- Development phase
- 3
- Enrollment target
NCT05130983: Clinical Trial Phase 1 study, sponsored by Direct Biologics.
NCT05130983 is a Phase 1 study that was terminated before completion, run by Direct Biologics. 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
NCT05130983, a Phase 1 study, was terminated before completion, sponsored by Direct Biologics.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 3 participants
- Enrollment target
Study Summary
Protocol Summary * Title: A Phase I study of ExoFlo, an ex vivo culture-expanded adult allogeneic bone marrow mesenchymal stem cell derived extracellular vesicle isolate product, for the treatment of medically refractory Crohn's disease. * Short Title: ExoFlo for Crohn's Disease * Phase: 1 * Methodology: Open label * Study Duration: 24 months * Subject Participation: 58 weeks * Single or Multi-Site: Multi-Site
Primary Outcome
Safety will be defined as lack of serious adverse events or adverse advents related to treatment with the study therapeutic.
Interventions
- BIOLOGICAL ExoFlo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2023-01-23 |
| Est. Completion | 2024-12-01 |
| Phase | Phase 1 |
Why NCT05130983 stopped before completion
NCT05130983 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 1 intervention - of which ExoFlo is the first listed.
NCT05130983 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05130983 about?
NCT05130983 is a clinical study titled "Study of ExoFlo for the Treatment of Medically Refractory Crohn's Disease". Protocol Summary * Title: A Phase I study of ExoFlo, an ex vivo culture-expanded adult allogeneic bone marrow mesenchymal stem cell derived extracellular vesicle isolate product, for the treatment of medically refractory Crohn's disease. * Short Title: ExoFlo for Crohn's Disease * Phase: 1 * Method...
What is the current status of trial NCT05130983?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 3 participants. The study started on 2023-01-23. Estimated completion is 2024-12-01.
What interventions are being tested in trial NCT05130983?
The interventions under investigation include: ExoFlo (BIOLOGICAL).
Who is sponsoring clinical trial NCT05130983?
This trial is sponsored by Direct Biologics, which has 7 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05130983'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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