A Phase 2a Study of DB-3Q for the Treatment of Medically Refractory Crohn's Disease
Direct Biologics, LLC
Summary
This research study is studying DB-3Q as a possible treatment for medically refractory Crohn's disease. The purpose of this study is to research and evaluate safety and effectiveness of the administration of bone marrow mesenchymal stem cell (bmMSC) derived extracellular vesicles product, DB-3Q, the study drug for Crohn's disease.
Eligibility
- Age range
- 18–75 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Written informed consent from participant 2. Males and females 18-75 years of age 3. Diagnosed with Crohn's disease of at least 6 months duration with medically refractory symptoms that failed to respond or responded but recurred after one advanced immunologic therapy (must have been receiving at least one advanced immunological therapy for 14 weeks duration prior to screening, including, but not limited to, adalimumab, certolizumab, , infliximab, risankizumab, upadacitinib, ustekinumab and vedolizumab), or is intolerant, or has a contraindication to advanced immunologi…
Interventions
- BiologicalDB-3Q
bmMSC derived, extracellular vesicle enriched secretome product
- OtherPlacebo
0.9% Saline
Location
- Washington University, St. LouisSt Louis, Missouri