Evaluation of therapeutic safety and clinical efficacy of MSC transplantation in septic shock.
ID
Source
Brief title
Condition
- Other condition
- Immune disorders NEC
- Ancillary infectious topics
Synonym
Health condition
septisch shock
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary parameters: the dose of norepinephrine and the systolic blood pressure
at specified time points.
The primary outcome measure: shock-reversal time.
Definition: 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.
(See section 8.1 of the research protocol)
Secondary outcome
Secondary endpoints:
1. treatment related toxicity
2. systemic immune cell response
3. disease severity and outcome
(See for detailed description section 8.2 and 8.3 of the research protocol)
Background summary
Despite appropriate antimicrobial therapy and supportive care, septic shock is
still a major cause of mortality and morbidity. Within the last decade, a
growing body of evidence suggests a potential role for mesenchymal stroma cell
(MSC) 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 objective
Evaluation of therapeutic safety and clinical efficacy of MSC transplantation
in septic shock.
Study design
Randomized proof-of-concept single-center intervention study.
Intervention
Infusion: 60 or 90 x 106 MSCs, dependent of weight, supplementary to the
standard care in the experimental arm and only standard care in the control arm.
Frequnecy: daily for 3 days (first dose within 6 hours of diagnsosis)
Study burden and risks
The burden associated with participation consists of MSC infusion and blood
sampling at specified time points.
The theoretical and on experimental studies based risks associated might be the
MSC differentiation in unwanted cell types, the stimulation of growth of
previously undetected tumour and the development of ectopic grafting. To our
knowledge, in human studies, there were no (serious) adverse events and adverse
side effects in the post-infusion period. Most of the human studies described
taste and smell abnormalities during infusion.
Considering the life-threatening nature of septic shock with multiple organ
failure, we expect benefit in terms of shock-reversal, that can be seen as the
forerunner of survival from this deadly syndrome.
(See for detailed information section 6.4 and Appendix A of the research
protocol)
's Gravendijkwal 230
Rotterdam 3015 CE
NL
's Gravendijkwal 230
Rotterdam 3015 CE
NL
Listed location countries
Age
Inclusion criteria
Patients between 18 and 75 years, fulfilling the criteria for pneumonia septic shock. ;(see chapter 4.2 and Appendix B of the research protocol)
Exclusion criteria
Moribund and where death is imminent, pregnancy, inflammatory diseases from any other origin then sepsis, chronic pulmonary or kidney disorders, active malignancies, single organ or other stem cell transplantations and participation in other clinical intervention studies. ;(see section 4.3 of the research protocol)
Design
Recruitment
Medical products/devices used
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 |
|---|---|
| EudraCT | EUCTR2011-006358-98-NL |
| CCMO | NL39348.000.13 |