Treatment of Severe Infections With Mesenchymal Stem Cells

Septic Shock Clinical Trial

— CHOCMSC  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02883803
• Other study ID #: PHRCI 2012/CHOCMSC-GIBOT/SKJ
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 2019
• Est. completion date: November 2022

Study information

• Verified date: July 2019
• Source: Central Hospital, Nancy, France
• Contact: Sébastien GIBOT
• Phone: +33383852970
• Email: s.gibot[@]chu-nancy.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 66
• Est. completion date: November 2022
• Est. primary completion date: November 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Septic Shock
• Shock, Septic

Intervention

Biological:
• Injection of mesenchymal stem cells
Injection of mesenchymal stem cells
• Injection of albumin alone
Injection of albumin alone

Locations

Country	Name	City	State
France	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

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of living days without catecholamines		Day 28
Secondary	Number of living days without mechanical ventilation		Day 28
Secondary	Number of living days without dialysis		Day 28
Secondary	Duration of residence time in recovery unit		Day of exit from recovery unit, up to 90 days
Secondary	Mortality, across all causes		Day 28
Secondary	Mortality, across all causes		Day 90
Secondary	Administration safety (i.e. side effects)		up to 90 days