Effects of Mesenchymal Stem Cells Administration on Organ Failure During Septic Shock: Phase II Randomized Comparator-controlled Study
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 66
- Locations
- 4
- Primary Endpoint
- SOFA score
Study Overview
Brief Summary
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
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
MSC
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.
Intervention: Injection of mesenchymal stem cells (Biological)
Placebo
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.
Intervention: Injection of albumin alone (Biological)
Outcomes
Primary Outcomes
SOFA score
Time Frame: Day 7 (or death day or day of recovery unit exit if before day 7)
To assess the efficacy of a recovery treatment
Secondary Outcomes
- 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 90)
- Administration safety (i.e. side effects)(up to 90 days)