Prevention of Sepsis-related Organ Dysfunction With Allocetra-OTS (P-SOFA-1)

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