Ignite Creation Date:
2025-12-24 @ 7:48 PM
Ignite Modification Date:
2026-01-02 @ 12:37 AM
Study NCT ID:
NCT02883803
Status:
UNKNOWN
Last Update Posted:
2019-10-25
First Post:
2016-08-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Treatment of Severe Infections With Mesenchymal Stem Cells
Sponsor:
Central Hospital, Nancy, France
Organization:
Study Overview
Official Title:
Effects of Mesenchymal Stem Cells Administration on Organ Failure During Septic Shock: Phase II Randomized Comparator-controlled Study
Status:
UNKNOWN
Status Verified Date:
2019-07
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CHOCMSC
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:
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: