Cure8 trial brief
This trial tests a novel cell-derived extracellular vesicle therapy (DB-3Q) for people with Crohn’s disease who have not responded to standard advanced therapies. It may offer a different biologic approach if proven safe and effective in trials.
Adults with medically refractory Crohn’s disease, gastroenterologists and IBD clinicians, clinical researchers in cell-based therapies, and patients interested in clinical trial options.
This ClinicalTrials.gov record describes a Phase 2, interventional trial (recruiting) testing DB-3Q, a bone marrow mesenchymal stem cell (bmMSC)–derived extracellular vesicle–enriched secretome product, as an intravenous treatment for medically refractory Crohn’s disease.
The study plans randomized arms with three DB-3Q dose volumes (15 mL, 30 mL, 45 mL IV) and a placebo (0.9% saline) control, enrolling about 36 adults.
Primary outcome is change from baseline in SES-CD at 12 weeks; eligibility requires active Crohn’s disease and prior exposure or failure of at least one advanced immunologic therapy (examples listed include adalimumab, certolizumab, infliximab, risankizumab, upadacitinib, ustekinumab, vedolizumab).
The record lists detailed inclusion/exclusion criteria and required medication washout periods. This entry is a trial registration record; it describes the study design, interventions, planned outcomes, and eligibility but does not provide results or safety/efficacy findings.
This is a Phase 2 clinical trial registration with planned outcomes and eligibility but no posted results. The intervention is investigational and derived from bone marrow mesenchymal stem cell secretome; enrollment status is recruiting. As a registry record, it should be interpreted as a description of planned research rather than evidence of benefit or approved therapy.
Review the original publication for the complete reporting, methods, and context.
This Cure8 brief is based on source text from the linked article. Cure8 is informational only and is not a substitute for professional medical advice, diagnosis, or treatment.
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