3 recruiting, 3 terminated, 3 withdrawn, 2 no longer available. 7 Phase 2, 5 Phase 1, 1 Phase 3.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 7 | Withdrawn 3, Recruiting 2, Completed 1, Terminated 1 |
| Phase 1 | 5 | Terminated 3, Withdrawn 2 |
| Phase 3 | 1 | Recruiting 1 |
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| DB-3Q for the Treatment of Medically Refractory Crohn's Disease DB-3Q, Placebo - Crohn Disease (CD) | Phase 2 | Recruiting | Direct Biologics, LLC | 36 | 2026-06-01 | 2026-09-01 |
| DB-3Q bmMSC-EVs in Patients With Perianal Fistulizing Crohn's Disease DB-3Q, Placebo - Perianal Fistula Due to Crohn's Disease | Phase 2 | Recruiting | Direct Biologics, LLC | 36 | 2025-05-19 | 2026-05-15 |
| Bone Marrow Mesenchymal Stem Cell Derived Extracellular Vesicles Infusion Treatment for ARDS Bone Marrow Mesenchymal Stem Cell Derived Extracellular Vesicles, Saline - ARDS, Human | Phase 1 / Phase 2 | Withdrawn | Direct Biologics, LLC | 2024-12-01 | 2024-07-29 | |
| ExoFlo™ Infusion for Post-Acute COVID-19 and Chronic Post-COVID-19 Syndrome Bone Marrow Mesenchymal Stem Cell Derived Extracellular Vesicles, Saline - Covid19, Postviral Syndrome | Phase 1 / Phase 2 | Withdrawn | Direct Biologics, LLC | 2024-11-01 | 2024-11-22 | |
| Study of ExoFlo for the Treatment of Perianal Fistulas ExoFlo, Local injection of normal saline - Perianal Fistula, Crohn's Disease | Phase 1 / Phase 2 | Terminated | Direct Biologics, LLC | 5 | 2023-08-28 | 2026-08-11 |
| Study of ExoFlo for the Treatment of Medically Refractory Crohn's Disease ExoFlo - Crohn Disease, Inflammatory Bowel Diseases | Phase 1 | Terminated | Direct Biologics, LLC | 3 | 2023-01-23 | 2025-02-11 |
| Study of ExoFlo for the Treatment of Medically Refractory Ulcerative Colitis ExoFlo - Ulcerative Colitis, Inflammatory Bowel Diseases | Phase 1 | Terminated | Direct Biologics, LLC | 4 | 2022-12-19 | 2025-02-11 |
| Extracellular Vesicles Infusion Treatment for Mild-to-Moderate COVID-19 ExoFlo - COVID-19 | Phase 2 | Withdrawn | Direct Biologics, LLC | 2022-12-07 | 2024-02-13 | |
| Extracellular Vesicle Treatment for Acute Respiratory Distress Syndrome (ARDS) (EXTINGUISH ARDS) ExoFlo, Intravenous normal saline - Acute Respiratory Distress Syndrome, ARDS | Phase 3 | Recruiting | Direct Biologics, LLC | 970 | 2022-07-01 | 2026-02-23 |
| Extracellular Vesicle Infusion Treatment for COVID-19 Associated ARDS ExoFlo, Intravenous normal saline - COVID-19, ARDS | Phase 2 | Completed | Direct Biologics, LLC | 102 | 2020-09-24 | 2024-02-13 |
| Expanded Access for Use of bmMSC-Derived Extracellular Vesicles in Patients With COVID-19 Associated ARDS ExoFlo - Covid19, ARDS | No longer available | Direct Biologics, LLC | 2024-11-22 | |||
| Expanded Access for Use of ExoFlo in Abdominal Solid Organ Transplant Patients ExoFlo - Solid Organ Transplant Rejection, Organ Rejection Transplants | No longer available | Direct Biologics, LLC | 2024-07-29 |
COVID-19 (4) · Crohn Disease (3) · Inflammatory Bowel Diseases (2) · Respiratory Distress Syndrome (2) · Colitis, Ulcerative (1) · Cytokine Release Syndrome (1) · Dyspnea (1) · Hypoxia (1) · Lymphoma, Follicular (1)
Sodium Chloride (2)
United States (8)
Bill Arana (10)