Serial Assessment of Systemic Levels of Proinflammatory Cytokines in Septic Shock Patients Treated with Allogeneic Mesenchymal Stem Cells
CCCF ePoster library. Mei S. Oct 4, 2017; 198156; 89
Shirley Mei
Shirley Mei
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Serial Assessment of Systemic Levels of Proinflammatory Cytokines in Septic Shock Patients Treated with Allogeneic Mesenchymal Stem Cells

Schlosser, Kenny1,2; Wang, Jia-Pey1,2; Watpool, Irene1; Stewart, Duncan J.1,3; McIntyre, Lauralyn1,4,5; Mei, Shirley H.J1,2

1The Ottawa Hospital Research Institute, Ottawa, Canada; 2Department of Regenerative Medicine, University of Ottawa, Ottawa, Canada; 3Department of Cell and Molecular Medicine, University of Ottawa, Ottawa, Canada; 4Department of Medicine (Division of Critical Care), University of Ottawa, Ottawa, Canada; 5Department of Epidemiology and Community Medicine, University of Ottawa, Ottawa, Canada

INTRODUCTION: Septic shock is a severe health problem in the intensive care unit (ICU), with a mortality rate of approximately 20-40%1.  Despite advances, no specific treatment has emerged to reduce the burden of illness2.  In sepsis, infectious agents cause increased circulating levels of proinflammatory cytokines, which contribute to multiple organ injury and failure.  Our team has completed the first-in-human clinical trial, “Cellular Immunotherapy for Septic Shock” (CISS).  In phase 1, a dose escalation trial was conducted to examine the safety of three different doses of allogeneic mesenchymal stem cells (MSCs) (low: 0.3 million cells/kg, mid: 1.0 million cells/kg, or high: 3.0 million cells/kg) delivered intravenously to septic shock patients. 

METHODS: In the present study, we evaluated the temporal changes in plasma levels of three  proinflammatory  cytokines, interleukin 1 beta (IL-1β), IL-6 and tumor necrosis factor alpha (TNF-α), in septic shock patients treated with (interventional group, n=9 total; n=3 per dose) or without MSCs (observational control group, n=21 patients that met CISS eligibility criteria but received no intervention).  Serial plasma samples were collected at 0, 1, 4, 12, 24 and 72 hours after enrollment, with the baseline (t=0 hr) sample collected just prior to MSC infusion.  Cytokines were measured with luminex xMAP technology on a Bioplex platform according to manufacturer specifications (Bio-Rad). 

RESULTS: In the interventional group, no significant increase in plasma levels of IL-1β, IL-6 or TNF-α was observed over the time course of the study following MSC injection, compared to baseline levels or the observational control group.  Stratification of the interventional group by MSC dose also showed no significant increase in the cytokine levels even at the highest MSC dose, versus observational control group. 

CONCLUSION: In conclusion, septic shock patients that received escalating doses of allogeneic MSCs showed no exacerbation in the plasma levels of several proinflammatory cytokines, consistent with a safe non-immunogenic response to MSC treatment.  Subsequent trials will be designed to evaluate the therapeutic efficacy of MSC treatment.

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