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

Primary Purpose

Organ Dysfunction Syndrome Sepsis

Status

Completed

Phase

Phase 1

Locations

Israel

Study Type

Interventional

Intervention

Allocetra-OTS

About this trial

This is an interventional prevention trial for Organ Dysfunction Syndrome Sepsis focused on measuring Allocetra-OTS, Cell based therapy, Apoptotic cells

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Hadassah Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Allocetra-OTS

Allocetra-OTS Two doses

Arm Description

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

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

Outcomes

Primary Outcome Measures

Assessment of safety by determining the number of participants with any Adverse Events (AE),Serious Adverse Events (SAE) and fatal SAE

Incidence rates of any Adverse Events (AE), Serious Adverse Events (SAE) and fatal SAE

Secondary Outcome Measures

Organ function or support measurements

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

Incidence rate of Moratlity from any cause

Hospitalization

Cumulative days in Intensive care unit (ICU) or Intermediate Care Units (IMU) and/or in hospital.

CRP

Time to C-reactive protein (CRP) < 20 mg/L.

Lactate levels

Time to normal + 20% lactate levels

Full Information

NCT ID

NCT03925857

First Posted

April 1, 2019

Last Updated

May 17, 2020

Sponsor

Enlivex Therapeutics Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT03925857

Brief Title

Prevention of Sepsis-related Organ Dysfunction With Allocetra-OTS

Acronym

P-SOFA-1

Official Title

Prevention of Sepsis-related Organ Dysfunction With Allocetra-OTS

Study Type

Interventional

2. Study Status

Record Verification Date

May 2020

Overall Recruitment Status

Completed

Study Start Date

January 27, 2019 (Actual)

Primary Completion Date

December 10, 2019 (Actual)

Study Completion Date

January 12, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Enlivex Therapeutics Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Organ Dysfunction Syndrome Sepsis

Keywords

Allocetra-OTS, Cell based therapy, Apoptotic cells

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 1

Interventional Study Model

Sequential Assignment

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)

Allocation

Non-Randomized

Enrollment

10 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Allocetra-OTS

Arm Type

Experimental

Arm Description

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

Arm Title

Allocetra-OTS Two doses

Arm Type

Experimental

Arm Description

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

Intervention Type

Biological

Intervention Name(s)

Allocetra-OTS

Intervention Description

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 Measure Information:

Title

Assessment of safety by determining the number of participants with any Adverse Events (AE),Serious Adverse Events (SAE) and fatal SAE

Description

Incidence rates of any Adverse Events (AE), Serious Adverse Events (SAE) and fatal SAE

Time Frame

28 days follow up

Secondary Outcome Measure Information:

Title

Organ function or support measurements

Description

Time Frame

28 days follow up

Title

Mortality

Description

Incidence rate of Moratlity from any cause

Time Frame

28 days follow up

Title

Hospitalization

Description

Cumulative days in Intensive care unit (ICU) or Intermediate Care Units (IMU) and/or in hospital.

Time Frame

28 days follow up

Title

CRP

Description

Time to C-reactive protein (CRP) < 20 mg/L.

Time Frame

28 days follow up

Title

Lactate levels

Description

Time to normal + 20% lactate levels

Time Frame

28 days follow up

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Dror Mevorach, Prof

Organizational Affiliation

Enlivex Therapeutics LTD Email:mevorachd@gmail.com

Official's Role

Study Director

Facility Information:

Facility Name

Hadassah Medical Center

City

Jerusalem

ZIP/Postal Code

12000

Country

Israel

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

34659208

Citation

van Heerden PV, Abutbul A, Sviri S, Zlotnick E, Nama A, Zimro S, El-Amore R, Shabat Y, Reicher B, Falah B, Mevorach D. Apoptotic Cells for Therapeutic Use in Cytokine Storm Associated With Sepsis- A Phase Ib Clinical Trial. Front Immunol. 2021 Sep 30;12:718191. doi: 10.3389/fimmu.2021.718191. eCollection 2021.

Results Reference

derived

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Prevention of Sepsis-related Organ Dysfunction With Allocetra-OTS

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