Clinical trial NCT02883803: Treatment of Severe Infections With Mesenchymal Stem Cells
Official title: Effects of Mesenchymal Stem Cells Administration on Organ Failure During Septic Shock: Phase II Randomized Comparator-controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Septic Shock
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2016-08-30
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: SOFA score
timeFrame: Day 7 (or death day or day of recovery unit exit if before day 7)
Secondary outcomes:
measure: Number of living days without catecholamines
timeFrame: Day 28
measure: Number of living days without mechanical ventilation
timeFrame: Day 28
measure: Number of living days without dialysis
timeFrame: Day 28
measure: Duration of residence time in recovery unit
timeFrame: Day of exit from recovery unit, up to 90 days
measure: Mortality, across all causes
timeFrame: Day 28
measure: Mortality, across all causes
timeFrame: Day 90
measure: Administration safety (i.e. side effects)
timeFrame: up to 90 days
Other outcomes:
Locations:
city: Dijon
country: France
facility: Service de Réanimation Médicale, Hôpital Bocage
city: Nancy
country: France
facility: Service de Réanimation Médicale, Hôpital Central
city: Strasbourg
country: France
facility: Hôpital Hautepierre, Service de réanimation médicale
city: Vandoeuvre-les-Nancy
country: France
facility: UTCT, Hôpital Brabois
Study officials:
affiliation: Service de Réanimation Médicale, Hôpital Central, 54035, Nancy Cedex
name: Sébastien GIBOT
role: PRINCIPAL_INVESTIGATOR
References: