NCT03925857

Prevention of Sepsis-related Organ Dysfunction With Allocetra-OTS

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Enlivex Therapeutics Ltd. · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Organ Dysfunction Syndrome Sepsis

Interventions

Type	Name	Description
BIOLOGICAL	Allocetra-OTS	Allocetra-OTS contains allogeneic donor mononuclear enriched cells in the form of a liquid suspension with at least 40% early apoptotic cells. The suspension is prepared with Ringer's lactate solution.

Timeline

• Start date: 2019-01-27
• Primary completion: 2019-12-10
• Completion: 2020-01-12
• First posted: 2019-04-24
• Last updated: 2020-05-19

Locations

1 site across 1 country: Israel