Cellular Immunotherapy for Septic Shock (CISS2)
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|ClinicalTrials.gov Identifier: NCT03369275|
Recruitment Status : Not yet recruiting
First Posted : December 11, 2017
Last Update Posted : December 11, 2017
|Condition or disease||Intervention/treatment||Phase|
|Septic Shock Sepsis Pathologic Processes Shock Infection Systemic Inflammatory Response Syndrome Inflammation||Biological: Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells Other: Placebo||Phase 2|
Septic shock is a devastating illness and the most severe form of infection seen in the intensive care unit (ICU). It is characterized by cardiovascular collapse, failure of organs and is common with severe repercussions including a mortality of 20-40%. Survivors suffer long-term impairment in function and reduced quality of life (QOL). Despite decades of research examining different immune therapies, none has proven successful and supportive care remains the mainstay of therapy, at a cost of approximately 4-billion dollars in Canada annually. MSCs represent a potentially novel treatment for sepsis because in animal models, MSCs have been shown to modulate the immune system, increase pathogen clearance, restore organ function, and reduce death.
The Phase II multi-centre Cellular Immunotherapy for Septic Shock RCT (CISS2) will continue to evaluate safety, assess if there are signals for clinical efficacy and determine mechanisms of action and biological effects of MSCs in septic shock. To answer these aims, CISS2 will randomize 114 patients who are admitted to the ICU with septic shock to 300 million cryopreserved, allogeneic, bone marrow derived MSCs or placebo across 10 Canadian centres over approximately 2 years.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||114 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Cellular Immunotherapy for Septic Shock (CISS2) A Phase II Randomized Controlled Trial|
|Estimated Study Start Date :||March 2018|
|Estimated Primary Completion Date :||February 2020|
|Estimated Study Completion Date :||October 2020|
Experimental: Mesenchymal Stromal Cells (MSCs)
Intravenous infusion of 300 million Allogeneic, Bone Marrow-Derived Human Mesenchymal Stromal Cells
Biological: Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells
Cryopreserved Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells will be administered intravenously.
Placebo Comparator: Placebo
Intravenous infusion of Placebo, with excipients
Placebo, with excipients, will be administered intravenously.
- The reduction in days on mechanical ventilation, or renal replacement therapy, or vasopressors. [ Time Frame: Through to 28 days post-randomization ]The number of days free from each of these support measures.
- Incidence of treatment-emergent adverse events (Safety and tolerability) [ Time Frame: Through to 28 days post-randomization ]
- Biological endpoints as markers of vascular permeability [ Time Frame: At baseline, 1, 2, 3 and 7 days post-randomization ]Marker of vascular permeability (ex: Ang1 and 2), acute renal injury (ex: Urine TIMP2-IGFBP7, IL-18), muscle weakness (ex: micro RNA (miRNA) growth Differentiation Factor-15 and miR-181a)), mechanisms related to pathogen clearance (ex: cathelicidin, LL-37), and pro and anti-inflammatory cytokines (ex: IL-6, IL-8, IL-10, IL-1B and IL1-RA) related to potential MSC biological effects
- Mortality [ Time Frame: Through to 12 months post-randomization ]All-cause mortality
- Organ Failure Scores [ Time Frame: Through to 90 days post-randomization ]Sequential Organ Failure Assessment (SOFA) Score
- Organ Support Measures [ Time Frame: Through to 90 days post-randomization ]Duration of mechanical ventilation and/or vasopressor agents and/or dialysis/renal replacement therapy
- Length of ICU Stay (in days) [ Time Frame: Number of elapsed days from admission until ICU discharge, up to one year ]Time in ICU
- Length of Hospital Stay (in days) [ Time Frame: Number of elapsed days from admission until hospital discharge, up to one year ]Time in Hospital
- Hospital Re-Admissions [ Time Frame: At 28 days, 3 and 12 months post-randomization ]
- Patient Reported Outcomes-FIM [ Time Frame: 7 days and 6 months post-ICU discharge ]Functional Independence Measure (FIM)
- Patient Reported Outcomes-SF 36 [ Time Frame: 7 days and 6 months post-ICU discharge ]SF-36 Score
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03369275
|Contact: Josee Champagne||613-737-8899 ext firstname.lastname@example.org|
|Principal Investigator:||Lauralyn McIntyre, MD||The Ottawa Hospital Research Institute|