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ExoFlo for Perianal Fistulizing Crohn's Disease
NCT05836883Phase 2
Key facts
- Status
- Terminated
- Start
- Aug 2023
- Primary completion
- Dec 2024
- Countries
- 1
- Sponsor
- Direct Biologics
- Modality
- Lipid-based Nanoparticles, Cell Therapies
- Conditions
- Crohn's disease
01
Overview
Phase 2, randomised, single-blind trial of bone marrow mesenchymal stem cell derived extracellular vesicles in Crohn's disease (2 cohorts), sponsored by Direct Biologics. Primary endpoint: Adverse Events at 3 months. Started Aug 2023; status: terminated.
02
Design
2 arms- Study design
- RandomizedSingle-blind
Cohort 1: Placebo
Local injection 15 mL of normal saline on Day 0
Cohort 1: Treatment
Local injection of 15 mL of ExoFlo on Day 0
03
Who it enrols
Adults 18-75 with Crohn's Disease and perianal fistula(s) who failed at least one medical therapy and previous surgical intervention, with stable medical therapy and acceptable lab values.
04
Endpoints
Primary
Adverse Events
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