NCT02883803

Treatment of Severe Infections With Mesenchymal Stem Cells

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 66 (estimated)
• Sponsor: Central Hospital, Nancy, France · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

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.

Conditions

• Septic Shock

Interventions

Type	Name	Description
BIOLOGICAL	Injection of mesenchymal stem cells	Injection of mesenchymal stem cells
BIOLOGICAL	Injection of albumin alone	Injection of albumin alone

Timeline

• Start date: 2019-12-01
• Primary completion: 2021-11-01
• Completion: 2022-11-01
• First posted: 2016-08-30
• Last updated: 2019-10-25

Locations

4 sites across 1 country: France