drugset / Trial / NCT05130983

Study of ExoFlo for the Treatment of Medically Refractory Crohn's Disease

NCT05130983 ↗

Phase 1 Terminated 3 enrolled Direct Biologics, LLC
NaSingle-groupOpen-labelTreatment

Summary

Protocol Summary * Title: A Phase I study of ExoFlo, an 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. * Short Title: ExoFlo for Crohn's Disease * Phase: 1 * Methodology: Open label * Study Duration: 24 months * Subject Participation: 58 weeks * Single or Multi-Site: Multi-Site

Timeline

Start
2023-01-23
Primary completion
2024-12-01
Completion
2024-12-01

Outcome

Outcome not reported

Stopped (Enrollment): “Enrollment challenges.”

Drugs

EvaluationDrugModalityDoseRoute
Subject ExoFlo Other / unclassified 30 ml Intravenous

Indications