Treatment of Severe Infections With Mesenchymal Stem Cells

Not Applicable

• Conditions: Septic Shock
• Interventions: Biological: Injection of albumin alone; Biological: Injection of mesenchymal stem cells

• Registration Number: NCT02883803
• Lead Sponsor: Central Hospital, Nancy, France

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 Timeline

• Study First Submitted: 2016-08-25
• Study First Submitted QC: 2016-08-25
• Study First Posted: 2016-08-30
• Status Verified: 2019-07
• Last Update Submitted: 2019-10-24
• Last Update Posted: 2019-10-25
• Study Start: 2019-12
• Primary Completion: 2021-11
• Study Completion: 2022-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 66

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Injection of albumin alone	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.
MSC	Injection of mesenchymal stem cells	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.

Primary Outcome Measures

Name	Time	Method
SOFA score	Day 7 (or death day or day of recovery unit exit if before day 7)	To assess the efficacy of a recovery treatment

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (4)

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; 🇫🇷 Vandoeuvre-les-Nancy, France