Septic Shock Clinical Trial
Official title:
Russian Single-center Open Randomized Clinical Trial of the Impact of Mesenchymal Stromal Cells Therapy on Organ Dysfunction and 28-day Mortality in Patients With Septic Shock and Severe Neutropenia.
Septic shock remains a significant clinical problem associated with high rates of mortality
among neutropenic patient despite antimicrobial therapy and supportive care. Recently,
mesenchymal stromal cells (MSC) have demonstrated remarkable potential effect in sepsis. MSC
treatment significantly reduced mortality in septic mice receiving appropriate antimicrobial
therapy. MSCs reduced systemic inflammatory cytokine levels in mice, down-regulated of
inflammation and inflammation-related genes (such as interleukin-10, interleukin-6).
Bacterial clearance was greater in MSC-treated mice. Thus, MSCs have beneficial effects on
experimental sepsis and suggest that MSСs-therapy may be an effective adjunctive treatment
to reduce sepsis-related mortality.
The safety of MSCs is proved by Graft-versus-host disease treatment MSCs in patients after
bone marrow transplantation.
This study hypothesis is that MSCs reduce organ dysfunction/injury, systemic inflammation
and mortality in patients with septic shock and severe neutropenia.
The main goal of the study is to evaluate the impact of MSCs therapy on organ
dysfunction/injury, systemic inflammation and 28-day mortality in patients with septic shock
and severe neutropenia. All patients will be randomized in two groups: control group
(standard treatment of septic shock) and MSCs-group (standard treatment of septic shock +
MSCs infusion of 1-2 millions/kg/ day).
All activities related to this human subjects research have been guided by ethical principles and have been reviewed and approved Federalwide Assurance National Ctr for Hematology, FWA00006482. The goal of the trial is to evaluate plasma concentration of proinflammatory cytokine interleukin-6 and the antiinflammatory cytokine interleukin-10, plasma levels of blood creatinine, bilirubin, procalcitonin, C-reactive protein. Then we will evaluate requirement for renal replacement therapy, requirement for mechanical ventilation or non-invasive mechanical ventilation, pulmonary function-coefficient, partial oxygen pressure arterial blood level, electrocardiograms, Kaplan - Meier curve,28-days mortality. ;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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