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Treatment of Severe Infections With Mesenchymal Stem Cells (CHOCMSC)

Primary Purpose

Septic Shock

Status

Unknown status

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Injection of mesenchymal stem cells

Injection of albumin alone

About this trial

This is an interventional treatment trial for Septic Shock

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Service de Réanimation Médicale, Hôpital Bocage
Service de Réanimation Médicale, Hôpital Central
Hôpital Hautepierre, Service de réanimation médicale
UTCT, Hôpital Brabois

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

MSC

Placebo

Arm 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.

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.

Outcomes

Primary Outcome Measures

SOFA score

To assess the efficacy of a recovery treatment

Secondary Outcome Measures

Number of living days without catecholamines

Number of living days without mechanical ventilation

Number of living days without dialysis

Duration of residence time in recovery unit

Mortality, across all causes

Administration safety (i.e. side effects)

Full Information

NCT ID

NCT02883803

First Posted

August 25, 2016

Last Updated

October 24, 2019

Sponsor

Central Hospital, Nancy, France

1. Study Identification

Unique Protocol Identification Number

NCT02883803

Brief Title

Treatment of Severe Infections With Mesenchymal Stem Cells

Acronym

CHOCMSC

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2019

Overall Recruitment Status

Unknown status

Study Start Date

December 2019 (Anticipated)

Primary Completion Date

November 2021 (Anticipated)

Study Completion Date

November 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Central Hospital, Nancy, France

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Septic Shock

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

66 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

MSC

Arm Type

Experimental

Arm Description

Arm Title

Placebo

Arm Type

Sham Comparator

Arm 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 250 ml albumin 4%, infused for 30 minutes in central venous line.

Intervention Type

Biological

Intervention Name(s)

Injection of mesenchymal stem cells

Intervention Description

Injection of mesenchymal stem cells

Intervention Type

Biological

Intervention Name(s)

Injection of albumin alone

Intervention Description

Injection of albumin alone

Primary Outcome Measure Information:

Title

SOFA score

Description

To assess the efficacy of a recovery treatment

Time Frame

Day 7 (or death day or day of recovery unit exit if before day 7)

Secondary Outcome Measure Information:

Title

Number of living days without catecholamines

Time Frame

Day 28

Title

Number of living days without mechanical ventilation

Time Frame

Day 28

Title

Number of living days without dialysis

Time Frame

Day 28

Title

Duration of residence time in recovery unit

Time Frame

Day of exit from recovery unit, up to 90 days

Title

Mortality, across all causes

Time Frame

Day 28

Title

Mortality, across all causes

Time Frame

Day 90

Title

Administration safety (i.e. side effects)

Time Frame

up to 90 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Sébastien GIBOT

Phone

+33383852970

s.gibot@chu-nancy.fr

First Name & Middle Initial & Last Name or Official Title & Degree

Daniele BENSOUSSAN

Phone

+33383153779

d.bensoussan@chru-nancy.fr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sébastien GIBOT

Organizational Affiliation

Service de Réanimation Médicale, Hôpital Central, 54035, Nancy Cedex

Official's Role

Principal Investigator

Facility Information:

Facility Name

Service de Réanimation Médicale, Hôpital Bocage

City

Dijon

Country

France

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Pierre-Emmanuel Charles

Facility Name

Service de Réanimation Médicale, Hôpital Central

City

Nancy

Country

France

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Sébastien GIBOT

Facility Name

Hôpital Hautepierre, Service de réanimation médicale

City

Strasbourg

Country

France

Facility Name

UTCT, Hôpital Brabois

City

Vandoeuvre-les-Nancy

Country

France

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Danièle Bensoussan

First Name & Middle Initial & Last Name & Degree

Véronique Decot

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Treatment of Severe Infections With Mesenchymal Stem Cells

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