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Treatment of Severe Infections With Mesenchymal Stem Cells — CHOCMSC  

Septic Shock Clinical Trial

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

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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02883803
Study type Interventional
Source Central Hospital, Nancy, France
Contact Sébastien GIBOT
Phone +33383852970
Email s.gibot@chu-nancy.fr
Status Not yet recruiting
Phase N/A
Start date December 2019
Completion date November 2022
View Details
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