Prevention of Sepsis-related Organ Dysfunction With Allocetra-OTS

Phase 1

Completed

• Conditions: Organ Dysfunction Syndrome Sepsis
• Interventions: Biological: Allocetra-OTS

• Registration Number: NCT03925857
• Lead Sponsor: Enlivex Therapeutics Ltd.

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 Timeline

• Study Start: 2019-01-27
• Study First Submitted: 2019-04-01
• Study First Submitted QC: 2019-04-21
• Study First Posted: 2019-04-24
• Primary Completion: 2019-12-10
• Study Completion: 2020-01-12
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-17
• Last Update Posted: 2020-05-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• Suspected, presumed or documented infection from any source.
• Initiation of antibiotics.
• Meets Sepsis 3 criteria: The presence of organ dysfunction as identified by a total SOFA score ≥ 2 points above baseline.
• Adult male or female, age between 18 and 85.
• GCS of >13 with verbal score of 5.
• Signed written informed consent by the patient.

Exclusion Criteria

• Participation in an interventional investigational trial within 30 days prior to diagnosis of sepsis.
• Significant trauma requiring hospitalization within 30 days prior to diagnosis of sepsis.
• Surgical intervention or hospitalization within 45 days prior to diagnosis of sepsis.
• Pregnancy or breast-feeding female.
• Progressive or poorly-controlled malignancies or < 6 month after active treatment for cancer (chemotherapy or irradiation).
• Terminally ill patients defined as patients that prior to the current hospitalization are expected to live < 6 months (as assessed by the physician responsible for the patient).
• Known active acute or chronic viral infections, e.g. Hepatitis B Virus (HBV) or Hepatitis C Virus (HCV), Human Immunodeficiency Virus (HIV) or other chronic infection.
• Known severe chronic respiratory health problems with severe pulmonary hypertension (≥40 mmHg) or respirator dependency.
• Known active upper gastrointestinal (GI) tract ulceration or hepatic dysfunction including but not limited to: biopsy-proven cirrhosis; portal hypertension; episodes of past upper GI bleeding attributed to portal hypertension; or prior episodes of hepatic failure, encephalopathy, or coma.
• Known New York Heart Association (NYHA) class IV heart failure or unstable angina, ventricular arrhythmias, active ischemic heart disease, or myocardial infarction within six months prior to diagnosis of sepsis.
• Known immunocompromised state or medications known to be immunosuppressive.
• Organ allograft or previous history of stem cell transplantation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Allocetra-OTS	Allocetra-OTS	Standard of Care (SOC) Drug: One dose Allocetra-OTS 140 140x106 /kg
Allocetra-OTS Two doses	Allocetra-OTS	Standard of Care (SOC) Drug: Two doses Allocetra-OTS 140 140x106 /kg

Primary Outcome Measures

Name	Time	Method
Assessment of safety by determining the number of participants with any Adverse Events (AE),Serious Adverse Events (SAE) and fatal SAE	28 days follow up	Incidence rates of any Adverse Events (AE), Serious Adverse Events (SAE) and fatal SAE

Secondary Outcome Measures

Name	Time	Method
Organ function or support measurements	28 days follow up	* 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
Mortality	28 days follow up	Incidence rate of Moratlity from any cause
Hospitalization	28 days follow up	Cumulative days in Intensive care unit (ICU) or Intermediate Care Units (IMU) and/or in hospital.
CRP	28 days follow up	Time to C-reactive protein (CRP) \< 20 mg/L.
Lactate levels	28 days follow up	Time to normal + 20% lactate levels

Trial Locations

Locations (1)

Hadassah Medical Center; 🇮🇱 Jerusalem, Israel