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Treatment of Severe Infections With Mesenchymal Stem Cells (CHOCMSC)

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ClinicalTrials.gov Identifier: NCT02883803
Recruitment Status : Not yet recruiting
First Posted : August 30, 2016
Last Update Posted : September 20, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Septic Shock Biological: Injection of mesenchymal stem cells Biological: Injection of albumin alone Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Effects of Mesenchymal Stem Cells Administration on Organ Failure During Septic Shock: Phase II Randomized Comparator-controlled Study
Estimated Study Start Date : November 2018
Estimated Primary Completion Date : November 2021
Estimated Study Completion Date : November 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shock

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




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Number of living days without catecholamines [ Time Frame: Day 28 ]
  2. Number of living days without mechanical ventilation [ Time Frame: Day 28 ]
  3. Number of living days without dialysis [ Time Frame: Day 28 ]
  4. Duration of residence time in recovery unit [ Time Frame: Day of exit from recovery unit, up to 90 days ]
  5. Mortality, across all causes [ Time Frame: Day 28 ]
  6. Mortality, across all causes [ Time Frame: Day 90 ]
  7. Administration safety (i.e. side effects) [ Time Frame: up to 90 days ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02883803


Contacts
Contact: Sébastien GIBOT +33383852970 s.gibot@chu-nancy.fr
Contact: Daniele BENSOUSSAN +33383153779 d.bensoussan@chru-nancy.fr

Locations
France
Service de Réanimation Médicale, Hôpital Bocage Not yet recruiting
Dijon, France
Sub-Investigator: Pierre-Emmanuel Charles         
Service de Réanimation Médicale, Hôpital Central Not yet recruiting
Nancy, France
Sub-Investigator: Pierre Edouard Bollaert         
UTCT, Hôpital Brabois Not yet recruiting
Vandoeuvre-les-Nancy, France
Sub-Investigator: Danièle Bensoussan         
Sub-Investigator: Véronique Decot         
Sponsors and Collaborators
Central Hospital, Nancy, France
Investigators
Principal Investigator: Sébastien GIBOT Service de Réanimation Médicale, Hôpital Central, 54035, Nancy Cedex

Responsible Party: Central Hospital, Nancy, France
ClinicalTrials.gov Identifier: NCT02883803     History of Changes
Other Study ID Numbers: PHRCI 2012/CHOCMSC-GIBOT/SKJ
First Posted: August 30, 2016    Key Record Dates
Last Update Posted: September 20, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Shock, Septic
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Shock