Clinical trial NCT03925857: Prevention of Sepsis-related Organ Dysfunction With Allocetra-OTS
Official title: Prevention of Sepsis-related Organ Dysfunction With Allocetra-OTS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Organ Dysfunction Syndrome Sepsis
Keywords: Allocetra-OTS
Cell based therapy
Apoptotic cells
Lead sponsor: Enlivex Therapeutics Ltd.
Sponsor class: INDUSTRY
First posted: 2019-04-24
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
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.
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Assessment of safety by determining the number of participants with any Adverse Events (AE),Serious Adverse Events (SAE) and fatal SAE
timeFrame: 28 days follow up
Secondary outcomes:
measure: Organ function or support measurements
timeFrame: 28 days follow up
measure: Mortality
timeFrame: 28 days follow up
measure: Hospitalization
timeFrame: 28 days follow up
measure: CRP
timeFrame: 28 days follow up
measure: Lactate levels
timeFrame: 28 days follow up
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Center
Study officials:
affiliation: Enlivex Therapeutics LTD Email:mevorachd@gmail.com
name: Dror Mevorach, Prof
role: STUDY_DIRECTOR
References:
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.