Drugs / ExoFlo
Trials 10
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT05130983 | Jan 2023 → Dec 2024 | Crohn disease | Direct Biologics, LLC | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1 | NCT05176366 | Dec 2022 → Dec 2024 | ulcerative colitis | Direct Biologics, LLC | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1/23 trials | ||||||
| Phase 1/2 | NCT05127122 | Dec 2024 | acute respiratory distress syndrome | Direct Biologics, LLC | Withdrawn | No outcome recorded |
| Phase 1/2 | NCT05116761 | Nov 2024 | COVID-19, long COVID-19 | Direct Biologics, LLC | Withdrawn | No outcome recorded |
| Phase 1/2 | NCT05836883 | Aug 2023 → Dec 2024 | Crohn disease, anal fistula | Direct Biologics, LLC | Terminated | No outcome recorded Stop: Enrollment |
| Phase 22 trials · 1 missed | ||||||
| Phase 2 | NCT05125562 | Dec 2022 → Mar 2023 | COVID-19 | Direct Biologics, LLC | Withdrawn | No outcome recorded |
| Phase 2 | NCT04493242 | Sep 2020 → May 2021 | COVID-19, acute respiratory distress syndrome | Direct Biologics, LLC | Completed | Missed primary |
| Phase 31 trial | ||||||
| Phase 3 | NCT05354141 | Jul 2022 → Nov 2027 expected | acute respiratory distress syndrome | Direct Biologics, LLC | Recruiting | No outcome recorded |
| Phase not stated2 trials | ||||||
| — | NCT04657458 | — | COVID-19, acute respiratory distress syndrome, cytokine release syndrome | Direct Biologics, LLC | No longer available | No outcome recorded |
| — | NCT05215288 | — | transplant rejection | Direct Biologics, LLC | No longer available | No outcome recorded |
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 11 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | ExoFlo | “This is a Phase I/II trial to evaluate the safety and efficacy of intravenous (IV) administration of bone marrow mesenchymal stem cell derived extracellular vesicles (EV),...” NCT05116761 ↗9“bone marrow mesenchymal stem cell-derived extracellular vesicles (EV), ExoFlo, as treatment for Acute Respiratory Distress Syndrome” NCT05127122 ↗ |
| Known as | ExoFloTM | “Early Mild Outpatient infusion Therapy with ExoFloTM for COVID-19 (EMOTE COVID-19)” NCT05125562 ↗ |
| Modality | Other / unclassified | “Bone marrow mesenchymal stem cell (BM-MSC)-derived extracellular vesicles (ExoFlo) convey the immunomodulatory and regenerative properties of intact BM-MSCs.” PMID 37356708 ↗ Jun 2023 |
| Route | Intravenous | “To evaluate the safety and efficacy of intravenous administration of bone marrow derived extracellular vesicles, ExoFlo, versus placebo as treatment for moderate-to-severe...” NCT04493242 ↗ |