Trials / Recruiting
RecruitingNCT06918808
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
- Status
- Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 36 (estimated)
- Sponsor
- Direct Biologics, LLC · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | DB-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. |
| BIOLOGICAL | Placebo | 0.9% NaCl |
Timeline
- Start date
- 2025-05-19
- Primary completion
- 2026-04-30
- Completion
- 2026-10-31
- First posted
- 2025-04-09
- Last updated
- 2026-02-23
Locations
3 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06918808. Inclusion in this directory is not an endorsement.