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

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ClinicalTrials.gov Identifier: NCT03925857
Recruitment Status : Completed
First Posted : April 24, 2019
Last Update Posted : May 19, 2020
Sponsor:
Information provided by (Responsible Party):
Enlivex Therapeutics Ltd.

Brief 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.

Condition or disease Intervention/treatment Phase
Organ Dysfunction Syndrome Sepsis Biological: Allocetra-OTS Phase 1

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description:

One Dose: 3 Sepsis patients will be treated with Allocetra-OTS, following safety assessment additional 3 patients will be treated (total 6 patients).

Two doses: Once safety is established 4 sepsis patients will be treated with 2 doses of Allocetra-OTS; The first, as in the first six patients and the second 48 hr following the first treatment.

Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Prevention of Sepsis-related Organ Dysfunction With Allocetra-OTS
Actual Study Start Date : January 27, 2019
Actual Primary Completion Date : December 10, 2019
Actual Study Completion Date : January 12, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sepsis

Arm Intervention/treatment
Experimental: Allocetra-OTS
Standard of Care (SOC) Drug: One dose Allocetra-OTS 140 140x106 /kg
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.

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




Primary Outcome Measures :
  1. Assessment of safety by determining the number of participants with any Adverse Events (AE),Serious Adverse Events (SAE) and fatal SAE [ Time Frame: 28 days follow up ]
    Incidence rates of any Adverse Events (AE), Serious Adverse Events (SAE) and fatal SAE


Secondary Outcome Measures :
  1. Organ function or support measurements [ Time Frame: 28 days follow up ]
    • 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

  2. Mortality [ Time Frame: 28 days follow up ]
    Incidence rate of Moratlity from any cause

  3. Hospitalization [ Time Frame: 28 days follow up ]
    Cumulative days in Intensive care unit (ICU) or Intermediate Care Units (IMU) and/or in hospital.

  4. CRP [ Time Frame: 28 days follow up ]
    Time to C-reactive protein (CRP) < 20 mg/L.

  5. Lactate levels [ Time Frame: 28 days follow up ]
    Time to normal + 20% lactate levels



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03925857


Locations
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Israel
Hadassah Medical Center
Jerusalem, Israel, 12000
Sponsors and Collaborators
Enlivex Therapeutics Ltd.
Investigators
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Study Director: Dror Mevorach, Prof Enlivex Therapeutics LTD Email:mevorachd@gmail.com
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Enlivex Therapeutics Ltd.
ClinicalTrials.gov Identifier: NCT03925857    
Other Study ID Numbers: ENX-CL-02-001
MOH_2019-02-17_005970 ( Registry Identifier: Israeli Ministry of Health )
First Posted: April 24, 2019    Key Record Dates
Last Update Posted: May 19, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Enlivex Therapeutics Ltd.:
Allocetra-OTS
Cell based therapy
Apoptotic cells
Additional relevant MeSH terms:
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Sepsis
Toxemia
Systemic Inflammatory Response Syndrome
Infections
Inflammation
Pathologic Processes
Shock