Treatment of severe infections with mesenchymal stem cells

Phase 1

• Conditions: septic shock; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2017-004123-67-FR
• Lead Sponsor: Centre Hospitalier Régional Universitaire de Nancy

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-01-15
• Last Update Posted: 3 May 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 66

Inclusion Criteria

1-Male Patient 18 years of age or older, or Woman over 65 years
2-Presence of community-acquired septic shock for less than 12 hours and associated with at least 2 organ failure other than cardiovascular. The time of septic shock onset is defined as the time of catecholamines introduction
3-Septic shock occurring between Monday 8:00 am and Friday 8:00 am (for reasons of availability of the staff of the UTCT)
4-Prior receipt of written consent (patient / trusted person / family member)
5-Person affiliated to a Social Security
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 33
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 33

Exclusion Criteria

1-Shock of non-septic origin
2-Nosocomial septic shock
3-PaO2 / FiO2 ratio <100
4-Female under 65 years
5-brain death
6-Moribund patient
7-Initial limatation of care or DNR orders
8-Patient already enrolled in another interventional tria, ongoing or for less than 30 days

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified