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

A Phase 2a Study of Allogeneic Bone Marrow Mesenchymal Stem Cell Derived Extracellular Vesicle Isolate Product (DB-3Q) in Patients With Perianal Fistulizing Crohn's Disease

NCT06918808•Direct Biologics, LLC

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Written informed consent from participant
•2. Men and women 18-75 years of age with a diagnosis of Crohn's Disease for at least six months duration prior to Day 1
•3. Single and/or multi-tract perianal fistula(s) with 2 or fewer openings, that are actively draining
•4. Failed at least one medical therapy within the last year including, but not limited to, antibiotics, immunomodulators (6-MP, methotrexate, azathioprine), monoclonal antibodies (adalimumab, certolizumab, golimumab, guselkumab, infliximab, risankizumab, ustekinumab, vedolizumab), or small molecule inhibitors (tofacitinib, upadacitinib)
•5. Previous failed surgical intervention, including seton placement at least two weeks prior to screening, or are not candidates for surgical intervention or are not willing to undergo surgical intervention for the management of their fistula
•6. Medical therapy for CD stable for at least 2 months prior to Day 1 (Changes in dosing or dosing intervals related to serum drug levels are not permitted)

Exclusion Criteria

•1. Lack of informed consent
•2. Pregnant woman, woman of childbearing potential without a documented negative urine or serum pregnancy test, or woman who is breast feeding
•3. A participant who is unwilling to use medically acceptable contraception methods during participation in study
•4. Active perianal abscess or infection at screening or Day 1
•5. Clinically significant medical conditions within six months before Day 1 that would, in the opinion of the Investigator, compromise the safety of the participant
•6. Confirmed HIV, Hepatitis B, or Hepatitis C infections
•7. History of cancer including melanoma (with the exception of localized non-melanoma skin cancers) within one year of screening
•8. History of colorectal cancer within 2 years of screening
•9. Use of investigational therapy or treatment within 30 days prior to Day 1

Locations (3)

Direct Biologics Investigational Site

Aurora, Colorado, United States

Direct Biologics Investigational Site

St Louis, Missouri, United States

Columbia University Irving Medical Center/NYPH

New York, New York, United States

Key Dates

Start Date

May 19, 2025

Primary Completion Date

April 30, 2026

Completion Date

October 31, 2026

Last Updated

February 23, 2026

Enrollment

ESTIMATED participants

Conditions

Perianal Fistula Due to Crohn's Disease

Interventions

DB-3Q

BIOLOGICAL

Placebo

BIOLOGICAL

Contacts

Executive Vice President, Clinical Affairs, MS

CONTACT

1-800-791-1021 clinicalaffairs@directbiologics.com

Safety of Allogeneic Human Umbilical Cord Mesenchymal Stem Cells (UC-MSCs) to Treat Perianal Fistulas w/ Crohn's Disease

NCT05039411

Perianal Fistula Due to Crohn's DiseaseFistula in Ano

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 23, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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