A Phase 2 interventional study of Allogeneic umbilical cord-derived human mesenchymal stromal cells and Placebo in Septic Shock, Sepsis and Pathologic Processes, sponsored by Ottawa Hospital Research Institute. Recruiting at 2 sites in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-12-05.
Sponsored by Ottawa Hospital Research Institute · Phase 2, Interventional, and Treatment
Septic shock is associated with substantial burden in terms of both mortality and morbidity for survivors of this illness. Pre-clinical sepsis studies suggest that mesenchymal stem (stromal) cells (MSCs) modulate inflammation, enhance pathogen clearance and tissue repair and reduce death. Our team has completed a Phase I dose escalation and safety clinical trial that evaluated MSCs in patients with septic shock. The Cellular Immunotherapy for Septic Shock Phase I (CISS) trial established that MSCs appear safe and that a randomized controlled trial (RCT) is feasible. Based on these data, the investigators have planned a phase II RCT (UC-CISS II) at several Canadian academic centres which will evaluate intermediate measures of clinical efficacy (primary outcome), as well as biomarkers, safety, clinical outcome measures, and a health economic analysis (secondary outcomes).
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 double blind Umbilical Cord Cellular Immunotherapy for Septic Shock RCT (UC-CISS II) will examine intermediate measures of clinical efficacy (primary outcome) as well as biomarkers, safety, clinical outcome measures, and a health economic analysis (secondary outcomes). To answer these aims, UC-CISS II will randomize 296 patients who are admitted to the ICU with septic shock to 300 million cryopreserved, allogeneic, umbilical cord-derived MSCs or placebo across several Canadian academic centres over approximately 2.5 years.
1,078 studies on the registry are indexed under Shock, Septic; 232 are open to participants now.
This study's planned enrollment of 296 is above the median of 79 across 636 interventional studies indexed under Shock, Septic.
Browse Shock, Septic studies →Ottawa Hospital Research Institute is the lead sponsor of 547 studies on the registry; 99 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
A participant must meet all the following inclusion criteria at time of randomization to be eligible:
There is at least 1 other acute organ failure according to modified individual Sequential Organ Failure Assessment Scores within 24 hours of meeting Cardiovascular organ failure defined by:
Acute organ failures that meet eligibility criteria must not have been present for greater than 48 hours prior to meeting the eligibility criteria.
Exclusion Criteria:
Patients will be excluded if they have at least one of the following at time of randomization:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Child-Pugh class
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Intravenous infusion of 300 million allogeneic, cryopreserved, umbilical cord-derived human mesenchymal stromal cells
Biological: Allogeneic umbilical cord-derived human mesenchymal stromal cells
Intravenous infusion of placebo, with excipients
Other: Placebo
Intravenous infusion of 300 million allogeneic, cryopreserved, umbilical cord-derived human mesenchymal stromal cells
Intravenous infusion of placebo, with excipients
Days free from mechanical ventilation and/or vasopressors and/or renal replacement therapy
The number of days free from each of these support measures
Time frame: Through to 28 days post-randomization
Biomarkers - Vascular permeability
Markers of vascular permeability (ex: Angpt1 and 2)
Time frame: At baseline, 1, 3 and 7 days post-randomization
Biomarkers - Acute kidney injury
Markers of acute kidney injury (ex: Urine TIMP2-IGFBP7, IL-18)
Time frame: At baseline, 1, 3 and 7 days post-randomization
Biomarkers - Muscle weakness
Markers of muscle weakness (ex: micro RNA \[miR\] miR-181a, growth differentiation Factor-15)
Time frame: At baseline, 1, 3 and 7 days post-randomization
Biomarkers - Pathogen clearance
Mechanisms related to pathogen clearance (ex: cathelicidin, LL-37)
Time frame: At baseline, 1, 3 and 7 days post-randomization
Biomarkers - Inflammatory mediators and cytokines
Pro- and anti-inflammatory mediators and cytokines (ex: CRP, IL-6, IL-8, IL-10, IL-1B and IL1-RA)
Time frame: At baseline, 1, 3 and 7 days post-randomization
Safety - Adverse Event
Safety of study treatment administration, examined for the occurrence of any adverse event (which requires treatment or intervention) regardless of relationship to study treatment
Time frame: Through to 7 days post-randomization
Safety - Serious and Unexpected Adverse Events
Safety of study treatment administration, examined for the occurrence of serious and unexpected adverse events that are considered possibly or related to the study treatment
Time frame: Through to 28 days post-randomization
Safety - Expected Adverse Events
Safety of study treatment administration, examined for the occurrence of expected adverse events (including nosocomial infections, acute coronary syndrome, tachy and bradyarrhythmia, clinically important bleeding, ARDS and thrombotic/thromboembolic events)
Time frame: Through to 28 days post-randomization
Mortality
All-cause mortality
Time frame: In ICU (through study completion, up to 1 year), in hospital (through study completion, up to 1 year), 28 days, 90 days, 6 months and 1 year post-randomization
Length of ICU Stay (in days)
Time in ICU
Time frame: Number of elapsed days from admission until ICU discharge, up to 1 year
Length of Hospital Stay (in days)
Time in hospital
Time frame: Number of elapsed days from admission until hospital discharge, up to 1 year
Hospital Re-Admissions
Re-admission to any hospital
Time frame: At 28 days, 90 days and 1 year post-randomization
ICU Re-Admissions
Re-admission to ICU during study hospital admission
Time frame: During index study hospital admission (through study completion, up to 1 year)
Organ Failure Rates
Organ failure rates (using Sequential Organ Failure Assessment Score), described individually and in composite
Time frame: Through to 90 days post-randomization
Days free from mechanical ventilation
Number of days free from mechanical ventilation
Time frame: Through to 90 days post-randomization
Days free from vasopressors
Number of days free from vasopressor agents
Time frame: Through to 90 days post-randomization
Days free from renal replacement therapy
Number of days free from renal replacement therapy
Time frame: Through to 90 days post-randomization
Patient Reported Outcomes - Functional Independence Measure (FIM)
FIM scores ranging from 18 to 126 (where the higher the score, the more independent the patient is)
Time frame: At 30 days, 6 months and 1 year post-randomization
Patient Reported Outcomes - Short Form Survey-36 (SF-36)
SF-36 scores ranging from 0 to 100 (with higher scores indicating better health status)
Time frame: At 30 days, 6 months and 1 year post-randomization
Health Economic Analysis
A cost-utility analysis of MSCs compared to placebo from a perspective of Canada's publicly funded health care system will be conducted
Time frame: Through to 28 days post-randomization
Plan to share: No
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