<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/NCT04451291</url>
  </required_header>
  <id_info>
    <org_study_id>U-DEPLOY: DSC-COVID-19</org_study_id>
    <secondary_id>20-5527</secondary_id>
    <nct_id>NCT04451291</nct_id>
  </id_info>
  <brief_title>Study of Decidual Stromal Cells to Treat COVID-19 Respiratory Failure</brief_title>
  <official_title>DSC-COVID-19: An Open-label Study on the Safety and Efficacy of Decidual Stromal Cells in Respiratory Failure Induced by COVID-19</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Health Network, Toronto</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Oslo University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University Health Network, Toronto</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>
      This is a research study to see how safe and effective decidual stromal cells are in treating&#xD;
      patients with respiratory failure (breathing problem where not enough oxygen is passed from&#xD;
      the lungs into the blood) caused by COVID-19.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      COVID-19 viral infectious disease that has lead to high numbers of critically ill patients or&#xD;
      death due to respiratory failure.&#xD;
&#xD;
      Decidual Stromal Cells (DSC) may be useful in the treatment of acute respiratory distress&#xD;
      syndrome (ARDS) by reducing lung inflammation and then time that patients require help with&#xD;
      breathing (mechanical ventilation).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">September 25, 2020</start_date>
  <completion_date type="Anticipated">March 25, 2023</completion_date>
  <primary_completion_date type="Anticipated">September 25, 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of ventilator free days following infusion of decidual stromal cells</measure>
    <time_frame>28 days</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mortality rate from COVID-19</measure>
    <time_frame>28 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mortality rate from COVID-19</measure>
    <time_frame>60 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mortality rate from COVID-19</measure>
    <time_frame>180 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>All-cause morality rate</measure>
    <time_frame>28 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>All-cause morality rate</measure>
    <time_frame>60 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>All-cause morality rate</measure>
    <time_frame>180 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Average number of days in ICU</measure>
    <time_frame>180 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Average number of days of hospital admittance</measure>
    <time_frame>180 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Average days not requiring vasopressors</measure>
    <time_frame>180 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall survival rate</measure>
    <time_frame>180 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Average viral clearance</measure>
    <time_frame>180 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Average number of days of supplemental oxygenation</measure>
    <time_frame>180 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Average number of day without supplemental oxygen</measure>
    <time_frame>180 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean PaO2/FiO2 as compared to patient baseline</measure>
    <time_frame>180 days</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">19</enrollment>
  <condition>COVID-19</condition>
  <condition>Acute Respiratory Distress Syndrome</condition>
  <arm_group>
    <arm_group_label>Decidual Stromal Cells (DSC)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive one dose of DSC at 1x10^6/kg. A second dose may be given sometime between Day 5 and Day 8 if the participant's condition improves.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Decidual Stromal Cells (DSC)</intervention_name>
    <description>DSCs are involved in the immune system during pregnancy. The DSCs used in this study will come from laboratory grown allogeneic human decidual stromal cells obtained from donated placentas.</description>
    <arm_group_label>Decidual Stromal Cells (DSC)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Able to provide informed consent for participation in the study, either by the&#xD;
             participant themselves or by the legally acceptable representative (LAR)&#xD;
&#xD;
          -  Virological diagnosis of SARS-CoV-2 infection (PCR)&#xD;
&#xD;
          -  Acute respiratory distress syndrome (ARDS) not due to cardiac causes&#xD;
&#xD;
          -  Receiving mechanical ventilation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Severe comorbidity with life expectancy &lt;3 months according to investigators&#xD;
             assessment&#xD;
&#xD;
          -  Currently receiving extracorporeal membrane oxygenation (ECMO)&#xD;
&#xD;
          -  Patients with established positive bacterial blood cultures prior to enrollment or&#xD;
             suspicion of superimposed bacterial pneumonia&#xD;
&#xD;
          -  Patients with diagnosed significant pulmonary embolism or deep vein thrombosis in the&#xD;
             previous 3 months&#xD;
&#xD;
          -  Patients who have been intubated for more than 48 hours&#xD;
&#xD;
          -  Known hypersensitivity to dimethyl sulfoxide (DMSO) or to porcine or bovine proteins&#xD;
&#xD;
          -  Acute co-morbidity within 7 days before inclusion such as stroke&#xD;
&#xD;
          -  History of severe chronic history of heart disease, recent myocardial infarction or&#xD;
             unstable angina, lung disease (requiring home oxygen), pulmonary hypertension, or&#xD;
             liver comorbidities&#xD;
&#xD;
          -  Malignancy that requires treatment in the previous two years (excluding non-melanoma&#xD;
             skin malignancies treated by excision, or cryotherapy)&#xD;
&#xD;
          -  History of immunosuppression (immunomodulators or anti-rejection drugs in past year,&#xD;
             or active disease, autoimmune disease on treatment, transplant recipients) or&#xD;
             anaphylaxis&#xD;
&#xD;
          -  Refusal of blood products&#xD;
&#xD;
          -  Severe co-morbidity/co-morbidities which in the opinion of the investigators would&#xD;
             compromise safety assessments&#xD;
&#xD;
          -  Pregnant or breast-feeding&#xD;
&#xD;
          -  Actively participating on another trial of an investigational agent for ARDS&#xD;
&#xD;
          -  Unacceptable laboratory blood tests for alanine aminotransferase (ALT)/aspartate&#xD;
             aminotransferase (AST), neutrophils, or platelets&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>John Granton, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Toronto General Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Brampton Civic Hospital</name>
      <address>
        <city>Brampton</city>
        <state>Ontario</state>
        <zip>L6R 3J7</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Etobicoke General Hospital</name>
      <address>
        <city>Etobicoke</city>
        <state>Ontario</state>
        <zip>M9V 1R8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Toronto General Hospital</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5G 2C4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>June 26, 2020</study_first_submitted>
  <study_first_submitted_qc>June 26, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 30, 2020</study_first_posted>
  <last_update_submitted>May 9, 2022</last_update_submitted>
  <last_update_submitted_qc>May 9, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 10, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
    <mesh_term>Respiratory Distress Syndrome</mesh_term>
    <mesh_term>Respiratory Distress Syndrome, Newborn</mesh_term>
    <mesh_term>Respiratory Insufficiency</mesh_term>
    <mesh_term>Acute Lung Injury</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT04451291
org study id: U-DEPLOY: DSC-COVID-19
secondary id: 20-5527
nct id: NCT04451291
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This is a research study to see how safe and effective decidual stromal cells are in treating
      patients with respiratory failure (breathing problem where not enough oxygen is passed from
      the lungs into the blood) caused by COVID-19.
COVID-19 viral infectious disease that has lead to high numbers of critically ill patients or
      death due to respiratory failure.

      Decidual Stromal Cells (DSC) may be useful in the treatment of acute respiratory distress
      syndrome (ARDS) by reducing lung inflammation and then time that patients require help with
      breathing (mechanical ventilation).
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of ventilator free days following infusion of decidual stromal cells
time frame: 28 days
measure: Mortality rate from COVID-19
time frame: 28 days
measure: Mortality rate from COVID-19
time frame: 60 days
measure: Mortality rate from COVID-19
time frame: 180 days
measure: All-cause morality rate
time frame: 28 days
measure: All-cause morality rate
time frame: 60 days
measure: All-cause morality rate
time frame: 180 days
measure: Average number of days in ICU
time frame: 180 days
measure: Average number of days of hospital admittance
time frame: 180 days
measure: Average days not requiring vasopressors
time frame: 180 days
measure: Overall survival rate
time frame: 180 days
measure: Average viral clearance
time frame: 180 days
measure: Average number of days of supplemental oxygenation
time frame: 180 days
measure: Average number of day without supplemental oxygen
time frame: 180 days
measure: Mean PaO2/FiO2 as compared to patient baseline
time frame: 180 days
arm group label: Decidual Stromal Cells (DSC)
arm group type: Experimental
description: Participants will receive one dose of DSC at 1x10^6/kg. A second dose may be given sometime between Day 5 and Day 8 if the participant's condition improves.
intervention type: Biological
intervention name: Decidual Stromal Cells (DSC)
description: DSCs are involved in the immune system during pregnancy. The DSCs used in this study will come from laboratory grown allogeneic human decidual stromal cells obtained from donated placentas.
arm group label: Decidual Stromal Cells (DSC)
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: John Granton, M.D.
role: Principal Investigator
affiliation: Toronto General Hospital
facility: 
facility: 
facility: 
country: Canada
responsible party type: Sponsor
mesh term: COVID-19
mesh term: Respiratory Distress Syndrome
mesh term: Respiratory Distress Syndrome, Newborn
mesh term: Respiratory Insufficiency
mesh term: Acute Lung Injury