Treatment of Severe Infections With Mesenchymal Stem Cells

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Effects of Mesenchymal Stem Cells Administration on Organ Failure During Septic Shock: Phase II Randomized Comparator-controlled Study

Conditions
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Septic Shock

Intervention / Treatment
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* Biological: Injection of mesenchymal stem cells
* Biological: Injection of albumin alone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Septic shock of community origin since less than 12 hours. The onset time of septic shock is the time of catecholamine introduction( adrenaline, noradrenaline, or dopamine > 8μg/kg/min) At least 2 organ failure other than hemodynamic Occurrence between Monday 8am and Friday 8am (for availability reasons of staff) Signature of informed consent (patient/close relative or reliable person) Affiliation to social security plan Exclusion Criteria: Non-septic shock Nosocomial septic shock PaO2/FiO2 <100 Pregnant or breast-feeding woman Brain death Dying person Therapeutic limitations Participation to another current interventional clinical trial or since less than 30 days

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MSC<br>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. | Biological: Injection of mesenchymal stem cells<br>* Injection of mesenchymal stem cells<br>|
| Sham Comparator: Placebo<br>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 250 ml albumin 4%, infused for 30 minutes in central venous line. | Biological: Injection of albumin alone<br>* Injection of albumin alone<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SOFA score | To assess the efficacy of a recovery treatment | Day 7 (or death day or day of recovery unit exit if before day 7) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of living days without catecholamines |  | Day 28 | 
| Number of living days without mechanical ventilation |  | Day 28 | 
| Number of living days without dialysis |  | Day 28 | 
| Duration of residence time in recovery unit |  | Day of exit from recovery unit, up to 90 days | 
| Mortality, across all causes |  | Day 28 | 
| Mortality, across all causes |  | Day 90 | 
| Administration safety (i.e. side effects) |  | up to 90 days |