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.
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 Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
10
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.
Hadassah Medical Center
Jerusalem, Israel
Assessment of safety by determining the number of participants with any Adverse Events (AE),Serious Adverse Events (SAE) and fatal SAE
Incidence rates of any Adverse Events (AE), Serious Adverse Events (SAE) and fatal SAE
Time frame: 28 days follow up
Organ function or support measurements
* Ventilator-free days, and/or * Vasopressor-free days, and/or * Days without renal replacement therapy (dialysis) and/or days with creatinine ≤ baseline +20%, and/or * Days with ≥ 100x109/L platelets count, and/or * Days with ≤ three times normal ALT (Alanine transaminase) and AST ••(Aspartate Aminotransferase) levels and/or ≤ two times normal bilirubin levels and/or * Days with return to GCS (Glasgow Coma Scale) 15
Time frame: 28 days follow up
Mortality
Incidence rate of Moratlity from any cause
Time frame: 28 days follow up
Hospitalization
Cumulative days in Intensive care unit (ICU) or Intermediate Care Units (IMU) and/or in hospital.
Time frame: 28 days follow up
CRP
Time to C-reactive protein (CRP) \< 20 mg/L.
Time frame: 28 days follow up
Lactate levels
Time to normal + 20% lactate levels
Time frame: 28 days follow up
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