Prevention of Sepsis-related Organ Dysfunction With Allocetra-OTS — P-SOFA-1  

Organ Dysfunction Syndrome Sepsis Clinical Trial

Official title: Prevention of Sepsis-related Organ Dysfunction With Allocetra-OTS

Status Completed

Clinical Trial Summary

The trial evaluates the safety and efficacy of one and two doses of the study drug, Allocetra-OTS, in patients who have been diagnosed with sepsis.

Clinical Trial Description

The study drug, Allocetra-OTS is a cell-based therapeutic composed of donor apoptotic cells. The product contains allogeneic mononuclear enriched cells in the form of a liquid suspension with at least 40% early apoptotic cells. The study drug, Allocetra-OTS, is based on the known activity of apoptotic cells to contribute to maintenance of peripheral immune homeostasis. As altered immune response is associated with organ dysfunction in sepsis, the possibility is being tested that the study drug can improve the condition of sepsis. ;

Related Conditions & MeSH terms

• Organ Dysfunction Syndrome Sepsis
• Sepsis
• Systemic Inflammatory Response Syndrome
• Toxemia

• NCT number: NCT03925857
• Study type: Interventional
• Source: Enlivex Therapeutics Ltd.
• Status: Completed
• Phase: Phase 1
• Start date: January 27, 2019
• Completion date: January 12, 2020