A Phase 2 Study Evaluating Efficacy, Safety and Tolerability of Different Doses and Regimens of Allocetra-OTS for the Treatment of Organ Failure in Adult Sepsis Patients

PHASE2CompletedINTERVENTIONAL
Enrollment

148

Participants

Timeline

Start Date

November 30, 2020

Primary Completion Date

January 12, 2024

Study Completion Date

December 16, 2024

Conditions
SepsisCommunity-acquired PneumoniaUrinary Tract InfectionsCholecystitis, AcuteCholangitis AcuteIntraabdominal Infections
Interventions
DRUG

Allocetra-OTS

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.

OTHER

Placebo

Solution containing all excipients except for the Allocetra-OTS cells

Trial Locations (31)

Unknown

Clinique Saint-Pierre, Brussels

Saint-Luc Hospital University, Brussels

CHU de Charleroi, Charleroi

Ziekenhuis Oost-Limburg, Genk

CHU d'Angers, Angers

Vendee Departmental Hospital Center, La Roche-sur-Yon

University Hospital of Limoges, Limoges

CHU de Montpellier, Montpellier

CHU de Nantes, Nantes

Bretonneau Hospital, Paris

Centre Hospitalier Victor Dupouy, Paris

Reims University Hospital Robert Debre, Reims

CHU de Rennes, Rennes

Strasbourg University Hospital, Strasbourg

Soroka Medical Center, Beersheba

Hillel Yaffe Medical Center, Hadera

Bnai Zion Medical Center, Haifa

Hadassah Ein Kerem Medical Center, Jerusalem

Beilinson Medical Center, Petah Tikva

Ziv Medical Center, Safed

Poriya Medical Center, Tiberias

Canisius Wilhelmina Hospital, Nijmegen

Radboud UMC, Nijmegen

Clinic Barcelona University Hospital, Barcelona

University Hospital Sagrat Cor, Barcelona

Vall d'Hebron, Barcelona

Getafe University Hospital, Getafe

Dr. Josep Trueta University Hospital, Girona

University Hospital Arnau de Vilanova of Lleida, Lleida

General University Hospital Gregorio Maranon, Madrid

University Hospital Joan XXIII of Tarragona, Tarragona

Sponsors
All Listed Sponsors
lead

Enlivex Therapeutics Ltd.

INDUSTRY

NCT04612413 - A Phase 2 Study Evaluating Efficacy, Safety and Tolerability of Different Doses and Regimens of Allocetra-OTS for the Treatment of Organ Failure in Adult Sepsis Patients | Biotech Hunter | Biotech Hunter