Prevention of Sepsis-related Organ Dysfunction With Allocetra-OTS

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-27

Study Completion Date

2020-01-12

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Organ Dysfunction Syndrome Sepsis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

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 Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Allocetra-OTS

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

Group Type EXPERIMENTAL

Allocetra-OTS

Intervention Type 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 Two doses

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

Group Type EXPERIMENTAL

Allocetra-OTS

Intervention Type 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.

Interventions

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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.

Intervention Type BIOLOGICAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No