No registrations found.
ID
Source
Brief title
Health condition
Mesenchymal stromal cell
Septic shock
Infection
Inflammation
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome measure will be the time of shock reversal.
Secondary outcome
1. The infusion and post-transfusion related toxicity;
2. Immune cell response;
3. Mortality;
4. Length of stay;
5. Pulmonary function;
6. Sepsis severity;
7. Microcirculatory disturbances.
Background summary
Despite appropriate antimicrobial therapy and supportive care, septic
shock is still a major cause of mortality and morbidity. A broad body of
evidence suggests a potential role for MSC therapy to ameliorate the
multifactorial process of septic shock. The major mechanisms involved
herein have been indicated as (a) immunomodulation, (b) stimulation of
anti-apoptotic pathways, and improvement of (c) endothelial and (d)
epithelial dysfunction. In this randomized proof-of-concept single-center
intervention study we will use a biologic approach to treat septic shock
by using these MSCs. Our main focus will be shortening of shock reversal
time. The reversal of shock is defined as the maintenance of systolic
blood pressure of at least 90 mmHg without vasopressor support for at
least 24 hours as described earlier. This novel model will improve
understanding of disease heterogeneity and shall provide further progress
in the treatment of shock associated organ failures.
Study objective
Despite appropriate antimicrobial therapy and supportive care, septic shock is still a major cause of mortality and morbidity. Within the last decade, a broad body of evidence suggests a potential role for mesenchymal stromal cell (MSC, a multipotent stem cell differentiating into a variety of cell types) therapy to ameliorate the multifactorial process of septic shock. The major mechanisms involved herein have been indicated as (a) immunomodulation in terms of a shift from pro- to anti-inflammatory state, (b) stimulation of anti-apoptotic pathways, and improvement of (c) endothelial and (d) epithelial dysfunction. We want to develop a novel approach to treat septic shock by using these MSCs.
Study design
Patients will be evaluated according to protocol until 28 days after randomization. Subsequently patients will be followed until 90 days after registration.
Intervention
Dose of 60 or 90 x 106 MSCs dependent on weight every 24 hours (first dose ≤ 6 hours of diagnosis) supplementary to the standard care in the experimental group.
Only standard care in the control group.
The expected maximum treatment duration after randomization will be 72 hours.
Department of Intensive Care Adults<br>
P.O. Box 2040
N. Kusadasi
Rotterdam 3000 CA
The Netherlands
n.kusadasi@erasmusmc.nl
Department of Intensive Care Adults<br>
P.O. Box 2040
N. Kusadasi
Rotterdam 3000 CA
The Netherlands
n.kusadasi@erasmusmc.nl
Inclusion criteria
1. Patients ≥18 years;
2. ≤6 hours of admission;
3. Having the diagnosis of septic shock.
Exclusion criteria
1. Age >75 years;
2. Moribund and where death is imminent;
3. Pregnancy;
4. Inflammatory diseases from any other origin then sepsis;
5. Chronic pulmonary or kidney disorders;
6. Active malignancies;
7. Single organ or other stem cell transplantations;
8. Participation in other clinical intervention studies.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL3333 |
| NTR-old | NTR3495 |
| Other | Erasmus MC Rotterdam : 2011-MSC-1 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |