Trials / Completed
CompletedNCT04612413
A Phase 2 Study Evaluating Efficacy, Safety and Tolerability of Different Doses and Regimens of Allocetra-OTS for the Treatment of Organ Failure in Adult Sepsis Patients
A Phase 2, Multi-Center, Randomized, Placebo-Controlled, Dose-Finding Study Evaluating Efficacy, Safety and Tolerability of Different Doses and Regimens of Allocetra-OTS for the Treatment of Organ Failure in Adult Sepsis Patients
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 148 (actual)
- Sponsor
- Enlivex Therapeutics Ltd. · Industry
- Sex
- All
- Age
- 18 Years – 90 Years
- Healthy volunteers
- Not accepted
Summary
A Phase 2, Multi-Center, Randomized, Placebo-Controlled, Dose-Finding Study Evaluating Efficacy, Safety and Tolerability of Different Doses and Regimens of Allocetra-OTS for the Treatment of Organ Failure in Adult Sepsis Patients
Detailed description
Allocetra-OTS is an immunomodulatory cell-based therapy consisting of allogeneic peripheral blood mononuclear cells that have been modified to be engulfed by macrophages and reprogram them into their homeostatic state. This is a multi-center, randomized, placebo-controlled, dose-finding study comparing the efficacy, safety and tolerability of different dosing regimens of Allocetra-OTS, in patients with sepsis. The study aims to compare the safety and efficacy of different doses and regimens of Allocetra-OTS, as well as the clinical manifestations following Allocetra-OTS treatment, to that of Placebo in the treatment of organ failure in adult sepsis patients.
Conditions
- Sepsis
- Community-acquired Pneumonia
- Urinary Tract Infections
- Cholecystitis, Acute
- Cholangitis Acute
- Intraabdominal Infections
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Allocetra-OTS | Allocetra-OTS is a cell-based therapy consisting of non-HLA-matched allogeneic peripheral blood mononuclear cells, derived from a healthy human donor following a leukapheresis procedure, induced to an apoptotic stable state and suspended in a solution containing DMSO. |
| OTHER | Placebo | Solution containing all excipients except for the Allocetra-OTS cells |
Timeline
- Start date
- 2020-11-30
- Primary completion
- 2024-01-12
- Completion
- 2024-12-16
- First posted
- 2020-11-03
- Last updated
- 2025-08-19
Locations
31 sites across 5 countries: Belgium, France, Israel, Netherlands, Spain
Source: ClinicalTrials.gov record NCT04612413. Inclusion in this directory is not an endorsement.