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
Direct Biologics, LLC
36 participants
May 19, 2025
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
Plain Language Summary
Simplified for easier understanding
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
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.
0.9% NaCl
Locations(3)
View Full Details on ClinicalTrials.gov
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NCT06918808