Ex Vivo Culture-expanded Adult Allogeneic Bone Marrow Mesenchymal Stem Cell Derived Extracellular Vesicle Isolate Product, for the Treatment of Medically Refractory Crohn's Disease

Part of paid clinical trials in St Louis, Missouri.

Sponsor
Direct Biologics, LLC
Study ID
NCT07625293
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Crohn Disease (CD)

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • DB-3Q — BIOLOGICAL
    bmMSC derived, extracellular vesicle enriched secretome product
  • Placebo — OTHER
    0.9% Saline

Study Details

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.

Key Dates

Start date
Jun 30, 2026
Status verified
Jun 2026
Primary completion
Jun 30, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
36 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: DB-3Q 15 mL IV
  • Experimental: DB-3Q 30 mL IV
  • Experimental: DB-3Q 45 mL IV
  • Placebo Comparator: Placebo IV

Primary Outcome Measure

Change from baseline in SES-CD Score [ Time Frame: 12 Weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIP
Washington University, St. LouisSt LouisMissouri63110

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Washington University, St. Louis· St Louis, MO

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