Ignite Creation Date:
2025-12-24 @ 6:39 PM
Ignite Modification Date:
2025-12-24 @ 6:39 PM
Study NCT ID:
NCT03925857
Status:
COMPLETED
Last Update Posted:
2020-05-19
First Post:
2019-04-01
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Prevention of Sepsis-related Organ Dysfunction With Allocetra-OTS
Sponsor:
Enlivex Therapeutics Ltd.
Organization:
Study Overview
Official Title:
Prevention of Sepsis-related Organ Dysfunction With Allocetra-OTS
Status:
COMPLETED
Status Verified Date:
2020-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
P-SOFA-1
Brief 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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| MOH_2019-02-17_005970 | REGISTRY | Israeli Ministry of Health | View |