Prevention of Sepsis-related Organ Dysfunction With Allocetra-OTS

NCT03925857 | Completed Phase 1 DMC

• 2 other identifiers: ENX-CL-02-001MOH_2019-02-17_005970
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Organ Dysfunction Syndrome Sepsis

Keywords

Allocetra-OTS; Cell based therapy; Apoptotic cells

Outcome Measures

Primary Outcomes (1)

• 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

  28 days follow up

Secondary Outcomes (5)

• Organ function or support measurements

  28 days follow up

• Mortality

  28 days follow up

• Hospitalization

  28 days follow up

• CRP

  28 days follow up

• Lactate levels

  28 days follow up

Study Arms (2)

Allocetra-OTS

EXPERIMENTAL

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

Biological: Allocetra-OTS

Allocetra-OTS Two doses

EXPERIMENTAL

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

Biological: Allocetra-OTS

Interventions

Allocetra-OTS BIOLOGICAL

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; Allocetra-OTS Two doses

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Enlivex Therapeutics Ltd.: lead

Study Sites (1)

Hadassah Medical Center

Jerusalem, 12000, Israel

Location

Related Publications (1)

• 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.

  PMID: 34659208 DERIVED

MeSH Terms

Conditions

Toxemia

Condition Hierarchy (Ancestors)

Infections

Study Officials

• Dror Mevorach, Prof

  Enlivex Therapeutics LTD Email:mevorachd@gmail.com

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 1, 2019
• First Posted: April 24, 2019
• Study Start: January 27, 2019
• Primary Completion: December 10, 2019
• Study Completion: January 12, 2020
• Last Updated: May 19, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)