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

Enlivex Therapeutics

Status and phase

Completed

Phase 1

Conditions

Organ Dysfunction Syndrome Sepsis

Treatments

Biological: Allocetra-OTS

Study type

Interventional

Funder types

Industry

Identifiers

NCT03925857

ENX-CL-02-001

MOH_2019-02-17_005970 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

10 patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

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