Prevention of Sepsis-related Organ Dysfunction With Allocetra-OTS

Organ Dysfunction Syndrome Sepsis Clinical Trial

— P-SOFA-1  

Official title:

Prevention of Sepsis-related Organ Dysfunction With Allocetra-OTS

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03925857
• Other study ID #: ENX-CL-02-001
• Secondary ID: MOH_2019-02-17_0
• Status: Completed
• Phase: Phase 1
• Start date: January 27, 2019
• Est. completion date: January 12, 2020

Study information

• Verified date: May 2020
• Source: Enlivex Therapeutics Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: January 12, 2020
• Est. primary completion date: December 10, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
Israel	Hadassah Medical Center	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Enlivex Therapeutics Ltd.

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	28 days follow up
Secondary	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	28 days follow up
Secondary	Mortality	Incidence rate of Moratlity from any cause	28 days follow up
Secondary	Hospitalization	Cumulative days in Intensive care unit (ICU) or Intermediate Care Units (IMU) and/or in hospital.	28 days follow up
Secondary	CRP	Time to C-reactive protein (CRP) < 20 mg/L.	28 days follow up
Secondary	Lactate levels	Time to normal + 20% lactate levels	28 days follow up