xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT05969275</url>
    </required_header>
    <id_info>
      <org_study_id>UC-CISSII</org_study_id>
      <nct_id>NCT05969275</nct_id>
    </id_info>
    <brief_title>Umbilical Mesenchymal Stromal Cells as Cellular Immunotherapy for Septic Shock</brief_title>
    <acronym>UC-CISSII</acronym>
    <official_title>Umbilical Mesenchymal Stromal Cells as Cellular Immunotherapy for Septic Shock: A Multi-Center, Double Blind, Phase II Randomized Controlled Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Ottawa Hospital Research Institute</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Canadian Institutes of Health Research (CIHR)</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Stem Cell Network</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Canadian Critical Care Trials Group</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Center for Regenerative Therapies Dresden (CRTD)</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Ottawa Hospital Research Institute</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Septic shock is associated with substantial burden in terms of both mortality and morbidity&#xD;
        for survivors of this illness. Pre-clinical sepsis studies suggest that mesenchymal stem&#xD;
        (stromal) cells (MSCs) modulate inflammation, enhance pathogen clearance and tissue repair&#xD;
        and reduce death. Our team has completed a Phase I dose escalation and safety clinical trial&#xD;
        that evaluated MSCs in patients with septic shock. The Cellular Immunotherapy for Septic&#xD;
        Shock Phase I (CISS) trial established that MSCs appear safe and that a randomized controlled&#xD;
        trial (RCT) is feasible. Based on these data, the investigators have planned a phase II RCT&#xD;
        (UC-CISS II) at several Canadian academic centres which will evaluate intermediate measures&#xD;
        of clinical efficacy (primary outcome), as well as biomarkers, safety, clinical outcome&#xD;
        measures, and a health economic analysis (secondary outcomes).&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Septic shock is a devastating illness and the most severe form of infection seen in the&#xD;
        intensive care unit (ICU). It is characterized by cardiovascular collapse, failure of organs&#xD;
        and is common with severe repercussions including a mortality of 20-40%. Survivors suffer&#xD;
        long-term impairment in function and reduced quality of life (QOL). Despite decades of&#xD;
        research examining different immune therapies, none has proven successful and supportive care&#xD;
        remains the mainstay of therapy, at a cost of approximately 4-billion dollars in Canada&#xD;
        annually. MSCs represent a potentially novel treatment for sepsis because in animal models,&#xD;
        MSCs have been shown to modulate the immune system, increase pathogen clearance, restore&#xD;
        organ function, and reduce death.&#xD;
  &#xD;
        The Phase II multi-centre double blind Umbilical Cord Cellular Immunotherapy for Septic Shock&#xD;
        RCT (UC-CISS II) will examine intermediate measures of clinical efficacy (primary outcome) as&#xD;
        well as biomarkers, safety, clinical outcome measures, and a health economic analysis&#xD;
        (secondary outcomes). To answer these aims, UC-CISS II will randomize 296 patients who are&#xD;
        admitted to the ICU with septic shock to 300 million cryopreserved, allogeneic, umbilical&#xD;
        cord-derived MSCs or placebo across several Canadian academic centres over approximately 2.5&#xD;
        years.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 2023</start_date>
    <completion_date type="Anticipated">March 2027</completion_date>
    <primary_completion_date type="Anticipated">March 2026</primary_completion_date>
    <phase>Phase 2</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <intervention_model_description>Randomized Controlled Trial</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
      <masking_description>Double-Blind</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Days free from mechanical ventilation and/or vasopressors and/or renal replacement therapy</measure>
      <time_frame>Through to 28 days post-randomization</time_frame>
      <description>The number of days free from each of these support measures</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Biomarkers - Vascular permeability</measure>
      <time_frame>At baseline, 1, 3 and 7 days post-randomization</time_frame>
      <description>Markers of vascular permeability (ex: Angpt1 and 2)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Biomarkers - Acute kidney injury</measure>
      <time_frame>At baseline, 1, 3 and 7 days post-randomization</time_frame>
      <description>Markers of acute kidney injury (ex: Urine TIMP2-IGFBP7, IL-18)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Biomarkers - Muscle weakness</measure>
      <time_frame>At baseline, 1, 3 and 7 days post-randomization</time_frame>
      <description>Markers of muscle weakness (ex: micro RNA [miR] miR-181a, growth differentiation Factor-15)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Biomarkers - Pathogen clearance</measure>
      <time_frame>At baseline, 1, 3 and 7 days post-randomization</time_frame>
      <description>Mechanisms related to pathogen clearance (ex: cathelicidin, LL-37)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Biomarkers - Inflammatory mediators and cytokines</measure>
      <time_frame>At baseline, 1, 3 and 7 days post-randomization</time_frame>
      <description>Pro- and anti-inflammatory mediators and cytokines (ex: CRP, IL-6, IL-8, IL-10, IL-1B and IL1-RA)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Safety - Adverse Event</measure>
      <time_frame>Through to 7 days post-randomization</time_frame>
      <description>Safety of study treatment administration, examined for the occurrence of any adverse event (which requires treatment or intervention) regardless of relationship to study treatment</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Safety - Serious and Unexpected Adverse Events</measure>
      <time_frame>Through to 28 days post-randomization</time_frame>
      <description>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</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Safety - Expected Adverse Events</measure>
      <time_frame>Through to 28 days post-randomization</time_frame>
      <description>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)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Mortality</measure>
      <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</time_frame>
      <description>All-cause mortality</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Length of ICU Stay (in days)</measure>
      <time_frame>Number of elapsed days from admission until ICU discharge, up to 1 year</time_frame>
      <description>Time in ICU</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Length of Hospital Stay (in days)</measure>
      <time_frame>Number of elapsed days from admission until hospital discharge, up to 1 year</time_frame>
      <description>Time in hospital</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Hospital Re-Admissions</measure>
      <time_frame>At 28 days, 90 days and 1 year post-randomization</time_frame>
      <description>Re-admission to any hospital</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>ICU Re-Admissions</measure>
      <time_frame>During index study hospital admission (through study completion, up to 1 year)</time_frame>
      <description>Re-admission to ICU during study hospital admission</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Organ Failure Rates</measure>
      <time_frame>Through to 90 days post-randomization</time_frame>
      <description>Organ failure rates (using Sequential Organ Failure Assessment Score), described individually and in composite</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Days free from mechanical ventilation</measure>
      <time_frame>Through to 90 days post-randomization</time_frame>
      <description>Number of days free from mechanical ventilation</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Days free from vasopressors</measure>
      <time_frame>Through to 90 days post-randomization</time_frame>
      <description>Number of days free from vasopressor agents</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Days free from renal replacement therapy</measure>
      <time_frame>Through to 90 days post-randomization</time_frame>
      <description>Number of days free from renal replacement therapy</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Patient Reported Outcomes - Functional Independence Measure (FIM)</measure>
      <time_frame>At 30 days, 6 months and 1 year post-randomization</time_frame>
      <description>FIM scores ranging from 18 to 126 (where the higher the score, the more independent the patient is)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Patient Reported Outcomes - Short Form Survey-36 (SF-36)</measure>
      <time_frame>At 30 days, 6 months and 1 year post-randomization</time_frame>
      <description>SF-36 scores ranging from 0 to 100 (with higher scores indicating better health status)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Health Economic Analysis</measure>
      <time_frame>Through to 28 days post-randomization</time_frame>
      <description>A cost-utility analysis of MSCs compared to placebo from a perspective of Canada's publicly funded health care system will be conducted</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">296</enrollment>
    <condition>Septic Shock</condition>
    <condition>Sepsis</condition>
    <condition>Pathologic Processes</condition>
    <condition>Shock</condition>
    <condition>Systemic Inflammatory Response Syndrome</condition>
    <condition>Inflammation</condition>
    <condition>Infections</condition>
    <arm_group>
      <arm_group_label>Umbilical Cord Mesenchymal Stromal Cells (UC-MSCs)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Intravenous infusion of 300 million allogeneic, cryopreserved, umbilical cord-derived human mesenchymal stromal cells</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Placebo</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>Intravenous infusion of placebo, with excipients</description>
    </arm_group>
    <intervention>
      <intervention_type>Biological</intervention_type>
      <intervention_name>Allogeneic umbilical cord-derived human mesenchymal stromal cells</intervention_name>
      <description>Intravenous infusion of 300 million allogeneic, cryopreserved, umbilical cord-derived human mesenchymal stromal cells</description>
      <arm_group_label>Umbilical Cord Mesenchymal Stromal Cells (UC-MSCs)</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Placebo</intervention_name>
      <description>Intravenous infusion of placebo, with excipients</description>
      <arm_group_label>Placebo</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          A participant must meet all the following inclusion criteria to be eligible:&#xD;
  &#xD;
            1. At least 18 years of age AND&#xD;
  &#xD;
            2. Requirement for admission to the intensive care unit AND&#xD;
  &#xD;
            3. Index admission to the intensive care unit AND&#xD;
  &#xD;
            4. Cardiovascular organ failure for at least 1 consecutive hour defined by the&#xD;
               requirement of at least 5 mcg/min of norepinephrine or 100 mcg/min of phenylephrine or&#xD;
               0.03 U/min vasopressin AND&#xD;
  &#xD;
            5. Clinician impression that cardiovascular organ failure is related to infection AND&#xD;
  &#xD;
            6. There is at least 1 other acute organ failure according to modified individual&#xD;
               Sequential Organ Failure Assessment Scores within 24 hours of meeting Cardiovascular&#xD;
               organ failure defined by:&#xD;
  &#xD;
                 1. Respiratory failure: invasive or non-invasive mechanical ventilation with a&#xD;
                    positive end expiratory pressure (PEEP) &gt;/= 5 cm H2O, OR high-flow nasal canula&#xD;
                    oxygen therapy (minimum total flow rate of 40 lpm); and a partial pressure of&#xD;
                    oxygen/fractional inspired oxygen concentration (P/F ratio) &lt;/= 200 OR&#xD;
  &#xD;
                 2. Hematological failure: platelet count of &lt;/= 100 X 10^9/L OR&#xD;
  &#xD;
                 3. Acute kidney injury: acute renal insufficiency with a creatinine of &gt;/= 200&#xD;
                    umol/L, or the requirement for new renal replacement therapy, or for participants&#xD;
                    with known chronic renal failure but not on dialysis, a 50% increase in their&#xD;
                    baseline creatinine concentration OR&#xD;
  &#xD;
                 4. Organ hypoperfusion: a lactate &gt;/= 4 mmol/L&#xD;
  &#xD;
          Acute organ failures that meet eligibility criteria must not have been present for greater&#xD;
          than 48 hours prior to admission to the ICU.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          Patients will be excluded if they have at least one of the following:&#xD;
  &#xD;
            1. Another form of shock (cardiogenic, hypovolemic, obstructive) OR&#xD;
  &#xD;
            2. History of known chronic pulmonary hypertension with a WHO functional class of IV OR&#xD;
  &#xD;
            3. History of severe chronic pulmonary disease requiring home oxygen OR&#xD;
  &#xD;
            4. History of severe chronic cardiac disease including congestive heart failure or&#xD;
               valvular dysfunction with a New York Heart Association Functional class IV or severe&#xD;
               chronic ischemic heart disease with a Canadian Cardiovascular Society angina class&#xD;
               score IV OR&#xD;
  &#xD;
            5. History of severe chronic liver disease (Child-Pugh Class C or model for end stage&#xD;
               liver disease (MELD) Score &gt;= 15) OR&#xD;
  &#xD;
            6. Malignancy in previous 1 year (excluding resolved non-melanoma skin cancer) OR&#xD;
  &#xD;
            7. Treating physician impression that death is imminent within the 12 hours after meeting&#xD;
               eligibility criteria OR&#xD;
  &#xD;
            8. Pregnant or lactating OR&#xD;
  &#xD;
            9. Family or patient not committed to aggressive care&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Lauralyn McIntyre, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>The Ottawa Hospital Research Institute</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Josee Champagne</last_name>
      <phone>613-737-8899</phone>
      <phone_ext>73836</phone_ext>
      <email>jochampagne@ohri.ca</email>
    </overall_contact>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 12, 2023</study_first_submitted>
    <study_first_submitted_qc>July 22, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 1, 2023</study_first_posted>
    <last_update_submitted>August 3, 2023</last_update_submitted>
    <last_update_submitted_qc>August 3, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 7, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Mesenchymal Stem Cells</keyword>
    <keyword>Mesenchymal Stromal Cells</keyword>
    <keyword>Randomized Controlled Trial</keyword>
    <keyword>Cryopreserved</keyword>
    <keyword>Allogeneic</keyword>
    <keyword>Umbilical Cord</keyword>
    <keyword>Phase II</keyword>
    <keyword>Sepsis</keyword>
    <keyword>Septic Shock</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Shock, Septic</mesh_term>
      <mesh_term>Inflammation</mesh_term>
      <mesh_term>Shock</mesh_term>
      <mesh_term>Systemic Inflammatory Response Syndrome</mesh_term>
      <mesh_term>Pathologic Processes</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT05969275
  org study id: UC-CISSII
  nct id: NCT05969275
  lead sponsor: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  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.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Randomized Controlled Trial
  primary purpose: Treatment
  masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  masking description: Double-Blind
  measure: Days free from mechanical ventilation and/or vasopressors and/or renal replacement therapy
  time frame: Through to 28 days post-randomization
  description: The number of days free from each of these support measures
  measure: Biomarkers - Vascular permeability
  time frame: At baseline, 1, 3 and 7 days post-randomization
  description: Markers of vascular permeability (ex: Angpt1 and 2)
  measure: Biomarkers - Acute kidney injury
  time frame: At baseline, 1, 3 and 7 days post-randomization
  description: Markers of acute kidney injury (ex: Urine TIMP2-IGFBP7, IL-18)
  measure: Biomarkers - Muscle weakness
  time frame: At baseline, 1, 3 and 7 days post-randomization
  description: Markers of muscle weakness (ex: micro RNA [miR] miR-181a, growth differentiation Factor-15)
  measure: Biomarkers - Pathogen clearance
  time frame: At baseline, 1, 3 and 7 days post-randomization
  description: Mechanisms related to pathogen clearance (ex: cathelicidin, LL-37)
  measure: Biomarkers - Inflammatory mediators and cytokines
  time frame: At baseline, 1, 3 and 7 days post-randomization
  description: Pro- and anti-inflammatory mediators and cytokines (ex: CRP, IL-6, IL-8, IL-10, IL-1B and IL1-RA)
  measure: Safety - Adverse Event
  time frame: Through to 7 days post-randomization
  description: Safety of study treatment administration, examined for the occurrence of any adverse event (which requires treatment or intervention) regardless of relationship to study treatment
  measure: Safety - Serious and Unexpected Adverse Events
  time frame: Through to 28 days post-randomization
  description: 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
  measure: Safety - Expected Adverse Events
  time frame: Through to 28 days post-randomization
  description: 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)
  measure: 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
  description: All-cause mortality
  measure: Length of ICU Stay (in days)
  time frame: Number of elapsed days from admission until ICU discharge, up to 1 year
  description: Time in ICU
  measure: Length of Hospital Stay (in days)
  time frame: Number of elapsed days from admission until hospital discharge, up to 1 year
  description: Time in hospital
  measure: Hospital Re-Admissions
  time frame: At 28 days, 90 days and 1 year post-randomization
  description: Re-admission to any hospital
  measure: ICU Re-Admissions
  time frame: During index study hospital admission (through study completion, up to 1 year)
  description: Re-admission to ICU during study hospital admission
  measure: Organ Failure Rates
  time frame: Through to 90 days post-randomization
  description: Organ failure rates (using Sequential Organ Failure Assessment Score), described individually and in composite
  measure: Days free from mechanical ventilation
  time frame: Through to 90 days post-randomization
  description: Number of days free from mechanical ventilation
  measure: Days free from vasopressors
  time frame: Through to 90 days post-randomization
  description: Number of days free from vasopressor agents
  measure: Days free from renal replacement therapy
  time frame: Through to 90 days post-randomization
  description: Number of days free from renal replacement therapy
  measure: Patient Reported Outcomes - Functional Independence Measure (FIM)
  time frame: At 30 days, 6 months and 1 year post-randomization
  description: FIM scores ranging from 18 to 126 (where the higher the score, the more independent the patient is)
  measure: Patient Reported Outcomes - Short Form Survey-36 (SF-36)
  time frame: At 30 days, 6 months and 1 year post-randomization
  description: SF-36 scores ranging from 0 to 100 (with higher scores indicating better health status)
  measure: Health Economic Analysis
  time frame: Through to 28 days post-randomization
  description: A cost-utility analysis of MSCs compared to placebo from a perspective of Canada's publicly funded health care system will be conducted
  arm group label: Umbilical Cord Mesenchymal Stromal Cells (UC-MSCs)
  arm group type: Experimental
  description: Intravenous infusion of 300 million allogeneic, cryopreserved, umbilical cord-derived human mesenchymal stromal cells
  arm group label: Placebo
  arm group type: Placebo Comparator
  description: Intravenous infusion of placebo, with excipients
  intervention type: Biological
  intervention name: Allogeneic umbilical cord-derived human mesenchymal stromal cells
  description: Intravenous infusion of 300 million allogeneic, cryopreserved, umbilical cord-derived human mesenchymal stromal cells
  arm group label: Umbilical Cord Mesenchymal Stromal Cells (UC-MSCs)
  intervention type: Other
  intervention name: Placebo
  description: Intravenous infusion of placebo, with excipients
  arm group label: Placebo
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Lauralyn McIntyre, MD
  role: Principal Investigator
  affiliation: The Ottawa Hospital Research Institute
  last name: Josee Champagne
  phone: 613-737-8899
  phone ext: 73836
  email: jochampagne@ohri.ca
  responsible party type: Sponsor
  mesh term: Shock, Septic
  mesh term: Inflammation
  mesh term: Shock
  mesh term: Systemic Inflammatory Response Syndrome
  mesh term: Pathologic Processes
  sharing ipd: No