RecruitingPhase 2NCT06918808

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


Sponsor

Direct Biologics, LLC

Enrollment

36 participants

Start Date

May 19, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new treatment called DB-3Q bmMSC-EVs — tiny particles derived from stem cells — injected directly into perianal fistulas in people with Crohn's disease. Perianal fistulas are tunnels forming near the anus that are a painful, hard-to-treat complication of Crohn's. **You may be eligible if...** - You are between 18 and 75 years old and have had Crohn's disease for at least 6 months - You have 1 or more actively draining perianal fistulas with 2 or fewer openings - You have tried and failed at least one prior medical treatment (antibiotics, immunosuppressants, or biologics) - You have either tried and failed surgical treatment or are not a candidate for or willing to undergo surgery - Your Crohn's medical therapy has been stable for at least 2 months **You may NOT be eligible if...** - You are pregnant or could become pregnant without using contraception - Your fistula is currently infected or has an abscess that has not been adequately treated Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALDB-3Q

DB-3Q (IMP) is the frozen liquid formulation of acellular secretome proteins and extracellular vesicles isolated from human bmMSC and processed under current Good Manufacturing Process standards.

BIOLOGICALPlacebo

0.9% NaCl


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

View Full Details on ClinicalTrials.gov

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NCT06918808


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