The main purpose 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. The secondary purpose is to assess the role of heterologous mesenchymal stem cells on the occurrence and duration of failure of each organ and on the mortality at day 28 and day 90. The safety of administration will be also assessed.
Patients hospitalized in recovery unit and having a very severe septic shock with community origin (≥ 2 organ failures other than hemodynamic) since less than 12 hours, will receive 10\^6/kg heterologous mesenchymal stem cells in 250 ml albumin 4%, infused for 30 minutes in central venous line or 250 ml albumin 4% alone.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
66
Injection of mesenchymal stem cells
Injection of albumin alone
Service de Réanimation Médicale, Hôpital Bocage
Dijon, France
Service de Réanimation Médicale, Hôpital Central
Nancy, France
Hôpital Hautepierre, Service de réanimation médicale
Strasbourg, France
UTCT, Hôpital Brabois
Vandœuvre-lès-Nancy, France
SOFA score
To assess the efficacy of a recovery treatment
Time frame: Day 7 (or death day or day of recovery unit exit if before day 7)
Number of living days without catecholamines
Time frame: Day 28
Number of living days without mechanical ventilation
Time frame: Day 28
Number of living days without dialysis
Time frame: Day 28
Duration of residence time in recovery unit
Time frame: Day of exit from recovery unit, up to 90 days
Mortality, across all causes
Time frame: Day 28
Mortality, across all causes
Time frame: Day 90
Administration safety (i.e. side effects)
Time frame: up to 90 days
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