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Clinical Trial Summary

To evaluate the safety and feasibility of ExoFlo as a treatment for Perianal Fistulizing Crohn's Disease.


Clinical Trial Description

This is a phase IB/IIA, multicenter, single-blind, placebo-controlled, dose-escalation design, randomized controlled trial for the treatment of Perianal Fistulizing Crohn's Disease. Subjects will be randomized 2:1 Investigational Medicinal Product (IMP) to normal saline (NS) in 3 cohorts of 12 subjects as follows: Cohort 1: Local injection of 15 mL of IMP or NS on Day 0 (8 IMP, 4 NS) Cohort 2: Local injection of 30 mL of IMP or NS on Day 0 (8 IMP, 4 NS) Cohort 3: Local injection of 30 mL of IMP or NS on Day 0 and Month 3 (8 IMP, 4 NS) ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05836883
Study type Interventional
Source Direct Biologics, LLC
Contact Bill Arana
Phone 1-800-791-1021
Email clinicalaffairs@directbiologics.com
Status Recruiting
Phase Phase 1/Phase 2
Start date August 28, 2023
Completion date December 2024

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