drugset / Trial / NCT05130983
Study of ExoFlo for the Treatment of Medically Refractory Crohn's Disease
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | ExoFlo | Other / unclassified | 30 ml | Intravenous |