septic shock
Conditions
Interventions
Product Name: Mesenchymal Stem Cells (MSCs)
Product Code: CSM-MO
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: Mesenchymal stem cells derived from allogeneic bone marrow
Other de
Sponsors
Centre Hospitalier Régional Universitaire de Nancy
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1-Male Patient 18 years of age or older, or Woman over 65 years 2-Presence of community-acquired septic shock for less than 12 hours and associated with at least 2 organ failure other than cardiovascular. The time of septic shock onset is defined as the time of catecholamines introduction 3-Septic shock occurring between Monday 8:00 am and Friday 8:00 am (for reasons of availability of the staff of the UTCT) 4-Prior receipt of written consent (patient / trusted person / family member) 5-Person affiliated to a Social Security Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 33 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 33
Exclusion criteria
Exclusion criteria: 1-Shock of non-septic origin 2-Nosocomial septic shock 3-PaO2 / FiO2 ratio <100 4-Female under 65 years 5-brain death 6-Moribund patient 7-Initial limatation of care or DNR orders 8-Patient already enrolled in another interventional tria, ongoing or for less than 30 days
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the effect of mesenchymal stem cells (MSCs) administered at the early phase of septic shock on the evolution of organ failure judged by the SOFA (Sepsis Organ Failure Assessment score) score on Day 7 (or the day of death or the day of discharge from the intensive care unit if before Day 7) compared to SOFA score observed in patients in the control group.;Secondary Objective: 1- To appreciate the role of the MSCs on the occurrence and duration of organ failure individually 2- To appreciate the effect MSCs on mortality judged at Day 28 and Day 90, the length of stay in intensive care unit 3-To study the immediate tolerance profile and at 3 months of an injection of allogeneic bone marrow CSMs at a dose of 1.106 / kg.;Primary end point(s): to determine the effect of mesenchymal stem cells (MSCs) administered at the early phase of septic shock on the evolution of organ failure judged by the SOFA (Sepsis Organ Failure Assessment score) score on Day 7 (or the day of death or the day of discharge from the intensive care unit if before Day 7) compared to SOFA score observed in patients in the control group.;Timepoint(s) of evaluation of this end point: Day 7 (or the day of death or the day of discharge from the intensive care unit if before Day 7) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary end point 1 i) the number of days alive without respiratory support on Day 28, (ii) the number of days alive without catecholamines on Day 28, (iii) the number of days alive without renal suppot at Day 28, (iv) the length of stay in the intensive care unit and in the hospital, Secondary end point 2 i) the mortality at Day 28, ii) the mortality at Day 90 Secondary end point 3 i) Transient decrease in PaO2 / FiO2 ratio (or arterial desaturation> 5%) within 2 hours of CSMs administration ii) Transient elevation of mean pulmonary arterial pressure (> 5 mHg) within 2 hours of CSMs administration iii) Chills, hyperthermia within 2 hours of CSMs administration iv) Occurrence of pulmonary embolism within 2 hours after CSMs administration v) Occurrence of side effects up to 90 days after MSC injection.;Timepoint(s) of evaluation of this end point: Secondary end point 1: Day 28 Secondary end point 2: Day 28 and Day 90 Secondary end point 3: within 2 hours after CSMs administration and within 3 months after CSMs administration | — |
Countries
France
Contacts
Public ContactChef de projet
Direction de la Recherche et de l'Innovation
Outcome results
None listed