A Phase 2, Multi-Center, Randomized, Placebo-Controlled, Dose-Finding Study Evaluating Efficacy, Safety and Tolerability of Different Doses and Regimens of Allocetra-OTS for the Treatment of Organ Failure in Adult Sepsis Patients
Allocetra-OTS is an immunomodulatory cell-based therapy consisting of allogeneic peripheral blood mononuclear cells that have been modified to be engulfed by macrophages and reprogram them into their homeostatic state. This is a multi-center, randomized, placebo-controlled, dose-finding study comparing the efficacy, safety and tolerability of different dosing regimens of Allocetra-OTS, in patients with sepsis. The study aims to compare the safety and efficacy of different doses and regimens of Allocetra-OTS, as well as the clinical manifestations following Allocetra-OTS treatment, to that of Placebo in the treatment of organ failure in adult sepsis patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
148
Allocetra-OTS is a cell-based therapy consisting of non-HLA-matched allogeneic peripheral blood mononuclear cells, derived from a healthy human donor following a leukapheresis procedure, induced to an apoptotic stable state and suspended in a solution containing DMSO.
Solution containing all excipients except for the Allocetra-OTS cells
Clinique Saint-Pierre
Brussels, Belgium
Saint-Luc Hospital University
Brussels, Belgium
CHU de Charleroi
Charleroi, Belgium
Ziekenhuis Oost-Limburg
Genk, Belgium
CHU d'Angers
Angers, France
Vendee Departmental Hospital Center
La Roche-sur-Yon, France
University Hospital of Limoges
Limoges, France
CHU de Montpellier
Montpellier, France
CHU de Nantes
Nantes, France
Bretonneau Hospital
Paris, France
...and 21 more locations
Efficacy: Change from baseline in SOFA score
Change from baseline in SOFA score throughout 28 days
Time frame: 28 days
Safety: Number and severity of AEs and SAEs
Number and severity of AEs and SAEs throughout 28 days follow up period
Time frame: 28 days
Ventilator-free days
Ventilator-free days over 28 days
Time frame: 28 days
Vasopressor-free days
Vasopressor-free days over 28 days.
Time frame: 28 days
Days without renal replacement therapy (dialysis).
Days without renal replacement therapy (dialysis).
Time frame: 28 days
Time in ICU and time in hospital
Time in ICU and time in hospital
Time frame: 28 days
Number of days with creatinine ≤ Baseline levels +20%
Number of days with creatinine ≤ Baseline levels +20%
Time frame: 28 days
All-cause mortality
All-cause mortality at Day 28 following first dose
Time frame: 28 days
Changes from baseline in CRP levels
Changes from baseline in CRP levels
Time frame: 28 days
Number and severity of AEs and Serious Adverse Events (SAEs)
Number and severity of AEs and Serious Adverse Events (SAEs) throughout 12 months follow up period
Time frame: 12 months
Detection of autoimmune and human leukocyte antigen (HLA) antibodies
Detection of autoimmune and human leukocyte antigen (HLA) antibodies
Time frame: 12 months
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