Mesenchymal stromal cell Septic shock Infection Inflammation
Conditions
Interventions
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 ho
Sponsors
Erasmus Medical Center Rotterdam
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients ≥18 years; 2. ≤6 hours of admission; 3. Having the diagnosis of septic shock.
Exclusion criteria
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 outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome measure will be the time of shock reversal. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Contacts
Public ContactN. Kusadasi
Erasmus Medical Center Rotterdam Department of Intensive Care Adults P.O. Box 2040
Outcome results
None listed