Organ Dysfunction Syndrome Sepsis
Conditions
Keywords
Allocetra-OTS, Cell based therapy, Apoptotic cells
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.
Interventions
BIOLOGICALAllocetra-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.
Sponsors
Enlivex Therapeutics Ltd.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
PREVENTION
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of safety by determining the number of participants with any Adverse Events (AE),Serious Adverse Events (SAE) and fatal SAE | 28 days follow up | Incidence rates of any Adverse Events (AE), Serious Adverse Events (SAE) and fatal SAE |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Organ function or support measurements | 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 | 28 days follow up | Incidence rate of Moratlity from any cause |
| Hospitalization | 28 days follow up | Cumulative days in Intensive care unit (ICU) or Intermediate Care Units (IMU) and/or in hospital. |
| CRP | 28 days follow up | Time to C-reactive protein (CRP) \< 20 mg/L. |
| Lactate levels | 28 days follow up | Time to normal + 20% lactate levels |
Countries
Israel
Outcome results
None listed