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DB-3Q bmMSC-EVs in Patients With Perianal Fistulizing Crohn's Disease
NCT06918808 · View on ClinicalTrials.gov ↗
Study Summary
This is a double-blind, randomized, placebo-controlled, sequential cohort, ascending dose clinical trial to evaluate the safety and determine the efficacy of ascending doses of DB-3Q for the treatment of Perianal Fistulizing Crohn's Disease.
Conditions Studied
Interventions
- BIOLOGICAL Placebo
- BIOLOGICAL DB-3Q
Study Locations (3)
Colorado
- Direct Biologics Investigational Site — Aurora
Missouri
- Direct Biologics Investigational Site — St Louis
New York
- Columbia University Irving Medical Center/NYPH — New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2025-05-19 |
| Est. Completion | 2026-10-31 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06918808
The ClinicalTrials.gov registry entry for NCT06918808 describes a study currently listed as recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 36 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Direct Biologics, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Perianal Fistula Due to Crohn's Disease appearing as the primary indexed condition, and to 2 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06918808 reports 3 study locations spanning 3 distinct geographic areas — top geographies include Colorado, Missouri, New York. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06918808 about?
NCT06918808 is a clinical study titled "DB-3Q bmMSC-EVs in Patients With Perianal Fistulizing Crohn's Disease". This is a double-blind, randomized, placebo-controlled, sequential cohort, ascending dose clinical trial to evaluate the safety and determine the efficacy of ascending doses of DB-3Q for the treatment of Perianal Fistulizing Crohn's Disease.
What is the current status of trial NCT06918808?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 36 participants. The study started on 2025-05-19. Estimated completion is 2026-10-31.
What conditions does trial NCT06918808 study?
This clinical trial studies the following conditions: Perianal Fistula Due to Crohn's Disease. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06918808?
The interventions under investigation include: Placebo (BIOLOGICAL), DB-3Q (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06918808?
This trial is sponsored by Direct Biologics, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06918808 being conducted?
This trial has 3 study locations across Colorado, Missouri, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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