Treatment of Severe Infections With Mesenchymal Stem Cells (CHOCMSC)

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

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.

Study Overview

• Status: Unknown
• Conditions: Septic Shock
• Intervention / Treatment: Biological: Injection of mesenchymal stem cells; Biological: Injection of albumin alone

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 Type: Interventional
• Enrollment (Anticipated): 66
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Dijon, France
    • Service de Réanimation Médicale, Hôpital Bocage
  • Nancy, France
    • Service de Réanimation Médicale, Hôpital Central
  • Strasbourg, France
    • Hôpital Hautepierre, Service de réanimation médicale
  • Vandoeuvre-les-Nancy, France
    • UTCT, Hôpital Brabois

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Biological: Injection of mesenchymal stem cells; Injection of mesenchymal stem cells
Sham Comparator: 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.	Biological: Injection of albumin alone; Injection of albumin alone

What is the study measuring?

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	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

Collaborators and Investigators

• Sponsor: Central Hospital, Nancy, France
• Investigators: Principal Investigator: Sébastien GIBOT, Service de Réanimation Médicale, Hôpital Central, 54035, Nancy Cedex

Study record dates

Study Major Dates

• Study Start (Anticipated): December 1, 2019
• Primary Completion (Anticipated): November 1, 2021
• Study Completion (Anticipated): November 1, 2022

Study Registration Dates

• First Submitted: August 25, 2016
• First Submitted That Met QC Criteria: August 25, 2016
• First Posted (Estimate): August 30, 2016

Study Record Updates

• Last Update Posted (Actual): October 25, 2019
• Last Update Submitted That Met QC Criteria: October 24, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Shock; Sepsis; Shock, Septic
• Other Study ID Numbers: PHRCI 2012/CHOCMSC-GIBOT/SKJ

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No