Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT05176366 · ClinicalTrials.gov registry record · Phase 1
Study of ExoFlo for the Treatment of Medically Refractory Ulcerative Colitis
A Phase 1 study, sponsored by Direct Biologics.
- Terminated
- Registry status
- Phase 1
- Development phase
- 4
- Enrollment target
NCT05176366: Clinical Trial Phase 1 study, sponsored by Direct Biologics.
NCT05176366 is a Phase 1 study that was terminated before completion, run by Direct Biologics. The registered enrollment target is 4 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (93% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05176366, a Phase 1 study, was terminated before completion, sponsored by Direct Biologics.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 4 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 ulcerative colitis. * Short Title: ExoFlo for ulcerative colitis * 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 | 4 participants |
| Start Date | 2022-12-19 |
| Est. Completion | 2024-12-01 |
| Phase | Phase 1 |
Why NCT05176366 stopped before completion
NCT05176366 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 4 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (93% lower).
The record links to 0 conditions, and to 1 intervention - of which ExoFlo is the first listed.
NCT05176366 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05176366 about?
NCT05176366 is a clinical study titled "Study of ExoFlo for the Treatment of Medically Refractory Ulcerative Colitis". 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 ulcerative colitis. * Short Title: ExoFlo for ulcerative colitis * Phase: 1 * ...
What is the current status of trial NCT05176366?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 4 participants. The study started on 2022-12-19. Estimated completion is 2024-12-01.
What interventions are being tested in trial NCT05176366?
The interventions under investigation include: ExoFlo (BIOLOGICAL).
Who is sponsoring clinical trial NCT05176366?
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 NCT05176366's enrollment target sits among peer trials
4 1995th of 2000 higher than 2 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI