A Phase 2 Study Evaluating Efficacy, Safety and Tolerability of Different Doses and Regimens of Allocetra-OTS for the Treatment of Organ Failure in Adult Sepsis Patients

Exclusion Criteria

• •1. Sepsis due to infection other than lung infection, UTI, IAI, skin/soft tissue infection or sepsis patients where site of infection is unclear or unknown.
• •2. On chronic dialysis.
• •3. Patients with acute pancreatitis
• •4. Moribund patients
• •5. Weight \<50 kg or \>120 kg or BMI \>40 kg/m\^2.
• •6. SOFA score ≥14 at screening.
• •7. Patients with nosocomial infection.
• •8. A known malignancy.
• •9. Patients with end-stage disease (unrelated to sepsis)
• •10. Known active symptomatic SARS-CoV-2 or chronic viral infections, such as HBV or HCV, HIV or other chronic infections.
• •11. Chronic respiratory disease.
• •12. Known active upper GI tract ulceration or hepatic dysfunction.
• •13. Known NYHA class IV heart failure or unstable angina, ventricular arrhythmias, acute coronary disease or myocardial infarction.
• •14. Known immunocompromised state or medications known to be immunosuppressive.
• •15. Organ allograft or previous history of stem cell transplantation.