Trial | NCT03925857  Report issue

Official Title

Prevention of Sepsis-related Organ Dysfunction With Allocetra-OTS

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    10
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.
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 Started
Jan 27
2019
Primary Completion
Dec 10
2019
Study Completion
Jan 12
2020
Last Update
May 19
2020

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.

Allocetra-OTS Experimental

Standard of Care (SOC) Drug: One dose Allocetra-OTS 140 140x106 /kg

Allocetra-OTS Two doses Experimental

Standard of Care (SOC) Drug: Two doses Allocetra-OTS 140 140x106 /kg

Criteria 

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
No Results Posted