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出境医 / 临床实验 / Prevention of Sepsis-related Organ Dysfunction With Allocetra-OTS (P-SOFA-1)

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

Study Description
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.
Study Design
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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
Arms and Interventions
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.
Outcome Measures
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


Eligibility Criteria
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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
Contacts and Locations

Locations
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Israel
Hadassah Medical Center
Jerusalem, Israel, 12000
Sponsors and Collaborators
Enlivex Therapeutics Ltd.
Investigators
Layout table for investigator information
Study Director: Dror Mevorach, Prof Enlivex Therapeutics LTD Email:mevorachd@gmail.com
Tracking Information
First Submitted Date  ICMJE April 1, 2019
First Posted Date  ICMJE April 24, 2019
Last Update Posted Date May 19, 2020
Actual Study Start Date  ICMJE January 27, 2019
Actual Primary Completion Date December 10, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 21, 2019) 		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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03925857 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 24, 2019)
  • 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
  • Mortality [ Time Frame: 28 days follow up ]
    Incidence rate of Moratlity from any cause
  • Hospitalization [ Time Frame: 28 days follow up ]
    Cumulative days in Intensive care unit (ICU) or Intermediate Care Units (IMU) and/or in hospital.
  • CRP [ Time Frame: 28 days follow up ]
    Time to C-reactive protein (CRP) < 20 mg/L.
  • Lactate levels [ Time Frame: 28 days follow up ]
    Time to normal + 20% lactate levels
Original Secondary Outcome Measures  ICMJE
 (submitted: April 21, 2019)
  • 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
  • Mortality [ Time Frame: 28 days follow up ]
    Moratlity from any cause
  • Hospitalization [ Time Frame: 28 days follow up ]
    Cumulative days in Intensive care unit (ICU) or Intermediate Care Units (IMU) and/or in hospital.
  • CRP [ Time Frame: 28 days follow up ]
    Time to C-reactive protein (CRP) < 20 mg/L.
  • Lactate levels [ Time Frame: 28 days follow up ]
    Time to normal + 20% lactate levels
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Prevention of Sepsis-related Organ Dysfunction With Allocetra-OTS
Official Title  ICMJE Prevention of Sepsis-related Organ Dysfunction With Allocetra-OTS
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE 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
Condition  ICMJE Organ Dysfunction Syndrome Sepsis
Intervention  ICMJE 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.
Study Arms  ICMJE
  • Experimental: Allocetra-OTS
    Standard of Care (SOC) Drug: One dose Allocetra-OTS 140 140x106 /kg
    Intervention: Biological: Allocetra-OTS
  • Experimental: Allocetra-OTS Two doses
    Standard of Care (SOC) Drug: Two doses Allocetra-OTS 140 140x106 /kg
    Intervention: Biological: Allocetra-OTS
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 21, 2019) 		10
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 12, 2020
Actual Primary Completion Date December 10, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Israel
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03925857
Other Study ID Numbers  ICMJE ENX-CL-02-001
MOH_2019-02-17_005970 ( Registry Identifier: Israeli Ministry of Health )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Enlivex Therapeutics Ltd.
Study Sponsor  ICMJE Enlivex Therapeutics Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Dror Mevorach, Prof Enlivex Therapeutics LTD Email:mevorachd@gmail.com
PRS Account Enlivex Therapeutics Ltd.
Verification Date May 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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