Study of ExoFlo for the Treatment of Medically Refractory Ulcerative Colitis

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 ulcerative colitis. * Short Title: ExoFlo for ulcerative colitis * Phase: 1 * Methodology: Open label * Study Duration: 24 months * Subject Participation: 58 weeks * Single or Multi-Site: Multi-Site

Timeline

Start

2022-12-19

Primary completion

2024-12-01

Completion

2024-12-01

Outcome

Outcome not reported

Stopped (Enrollment): “Enrollment challenges.”

Drugs

Indications