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DB-3Q for Perianal Fistulizing Crohn's Disease

This study is testing a treatment called DB-3Q for people with perianal fistulas (abnormal connections between the bowel and skin) caused by Crohn's disease. DB-3Q is made from special cells (human bone marrow mesenchymal stem cells, or bmMSC) and contains proteins and tiny sacs called extracellular vesicles. Researchers want to see if DB-3Q is safe and effective compared to a placebo (a salt water solution). You might be able to join if you are 18-75 years old, have had Crohn's disease for at least six months, and have one or two actively draining perianal fistulas. The main goal is to see if your fistulas heal completely by 24 weeks.

Study design
This is a double-blind, randomized study, meaning neither you nor your doctor will know if you're receiving DB-3Q or the placebo. It plans to enroll 36 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The main goal of the study is measured at 24 weeks, suggesting follow-up will occur at least until then.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06918808

DB-3Q bmMSC-EVs in Patients With Perianal Fistulizing Crohn's Disease

Recruiting
PHASE2Ages 18–75InterventionalTreatment
Direct Biologics, LLC
~36 participants
Updated 2026-05-15 on ClinicalTrials.gov
What's tested:DB-3QPlacebo

At a glance

Recruiting sites
5 of 5 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Combined Remission
Measured over 24 Weeks

Conditions

Perianal Fistula Due to Crohn's Disease

Explore related trials

Crohn DiseasePerianal fistula

Where it's being run

5 sites across 5 states
Colorado1
Missouri1
New York1
Pennsylvania1
Tennessee1

Who to contact

Executive Vice President, Clinical Affairs, MS
[email protected]
1-800-791-1021
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Exclusion

WBC \> 13 x 109 /L
Hemoglobin \< 8 g/dL
Platelet count \< 100,000/mL
AST/ALT \> 3 times the upper limit of normal
Creatinine \> 2 μmol/L
PT/INR: 2 times the upper limit of normal
Hemoglobin A1c \> 6.5 mg/dL 15. Use of investigational therapy or treatment within 30 days prior to Day 1

What this trial measures

  • Combined Remission24 Weeks

    Clinically confirmed 100% closure of all treated external openings, without development of new fistulas or abscesses and drainage \> 1 cm by the external openings, occurring spontaneously or after gentle finger compression; and on blinded central review of the MRI results, combined imaging endpoint of \>50% reduction in MAGNIFI-CD score and \>20% increase in perianal fistula fibrosis-to-fluid ratio.