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Adult stem cell transplantation in severe blood poisining.


- candidate number12926
- NTR NumberNTR3495
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR21-jun-2012
- Secondary IDs2011-MSC-1 Erasmus MC Rotterdam
- Public TitleAdult stem cell transplantation in severe blood poisining.
- Scientific TitleMesenchymal stromal cell transplantation in septic shock.
- ACRONYMMSC in septic shock
- hypothesisDespite 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.
- Healt Condition(s) or Problem(s) studiedSeptic shock , Infection, Inflammation, Mesenchymal stromal cell
- Inclusion criteria1. Patients ≥18 years;
2. ≤6 hours of admission;
3. Having the diagnosis of septic shock.
- Exclusion criteria1. 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.
- mec approval receivedno
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-sep-2013
- planned closingdate1-sep-2015
- Target number of participants30
- InterventionsDose 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.
- Primary outcomeThe primary outcome measure will be the time of shock reversal.
- Secondary outcome1. 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.
- TimepointsPatients will be evaluated according to protocol until 28 days after randomization. Subsequently patients will be followed until 90 days after registration.
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIES N. Kusadasi
- CONTACT for SCIENTIFIC QUERIES N. Kusadasi
- Sponsor/Initiator Erasmus Medical Center
- Funding
(Source(s) of Monetary or Material Support)
- PublicationsN/A
- Brief summaryDespite 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.
- Main changes (audit trail)
- RECORD21-jun-2012 - 6-jul-2012


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