To evaluate the safety and feasibility of ExoFlo as a treatment for Perianal Fistulizing Crohn's Disease.
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 cohorts of 12 subjects as follows: Cohort 1: Local injection of 15 mL of IMP or NS on Day 0 (8 IMP, 4 NS)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
5
Local injection of bone marrow mesenchymal stem cell derived extracellular vesicles
Placebo
Direct Biologics Investigational Site
Los Angeles, California, United States
Adverse Events
Time frame: 3 Months
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