<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/NCT02215811</url>
  </required_header>
  <id_info>
    <org_study_id>MSC-ARDS</org_study_id>
    <nct_id>NCT02215811</nct_id>
  </id_info>
  <brief_title>Treatment of Severe Acute Respiratory Distress Syndrome With Allogeneic Bone Marrow-derived Mesenchymal Stromal Cells</brief_title>
  <official_title>Treatment of Severe Acute Respiratory Distress Syndrome With Allogeneic Bone Marrow-derived Mesenchymal Stromal Cells</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Karolinska University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Karolinska Institutet</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Karolinska University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a multi-center, open-label, non-randomized controlled trial. Patients with&#xD;
      viral-induced acute respiratory distress syndrome (ARDS) on extracorporeal membrane&#xD;
      oxygenation (ECMO) will be eligible. Ten patients will be enrolled and receive allogeneic&#xD;
      bone marrow-derived mesenchymal stromal cells (BM-MSC). Ventilator parameters as well as&#xD;
      preoperative clinical characteristics and postoperative clinical outcomes will be registered.&#xD;
      Routine blood sampling, radiography, and bronchioalveolar lavage will be performed pre- and&#xD;
      postoperatively. Spirometry, quality of life assessment, and 6 minute walk test will be&#xD;
      performed postoperatively. All available data will be collected prospectively. Follow-up is&#xD;
      12 months. Informed consent will be obtained from relatives to patients meeting the inclusion&#xD;
      criteria before the initiation of any study-specific procedures.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>March 2014</start_date>
  <primary_completion_date type="Anticipated">December 2015</primary_completion_date>
  <phase>Phase 1</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>In-hospital mortality</measure>
    <time_frame>During hospital stay, an expected average 2 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pulmonary compliance</measure>
    <time_frame>During ventilator treatment, an expected average of 1 month</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pulmonary tidal volume</measure>
    <time_frame>During ventilator treatment, an expected average of 1 month</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse events</measure>
    <time_frame>6 months</time_frame>
    <description>I.e infection, fever, effect on end-organ function</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>All-cause mortality</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Recovery of organ functions</measure>
    <time_frame>12 months</time_frame>
    <description>kidney, liver, heart functions</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Immune modulation</measure>
    <time_frame>3 months</time_frame>
    <description>Change in T-cell, mononuclear cell, cytokine ans microRNA response towards an immunomodulatory phenotype</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">10</enrollment>
  <condition>Acute Respiratory Distress Syndrome, Adult</condition>
  <arm_group>
    <arm_group_label>Mesenchymal stromal cells</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Mesenchymal stromal cells</intervention_name>
    <arm_group_label>Mesenchymal stromal cells</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ≥ 18 years of age&#xD;
&#xD;
          -  Viral-induced acute respiratory distress syndrome&#xD;
&#xD;
          -  Ventilator treatment&#xD;
&#xD;
          -  Extracorporeal membrane oxygenation treatment&#xD;
&#xD;
          -  Relatives provide written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  None&#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>Karl-Henrik Grinnemo</last_name>
    <role>Principal Investigator</role>
    <affiliation>Karolinska Institutet</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Karl-Henrik Grinnemo, MD, PhD</last_name>
    <phone>+46 70 886 89 68</phone>
    <email>karl-henrik.grinnemo@karolinska.se</email>
  </overall_contact>
  <location>
    <facility>
      <name>Karolinska University Hospital</name>
      <address>
        <city>Stockholm</city>
        <country>Sweden</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Karl-Henrik Grinnemo, MD, PhD</last_name>
      <phone>+46 70 886 89 68</phone>
    </contact>
    <investigator>
      <last_name>Karl-Henrik Grinnemo, MD, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Katarina Le Blanc, MD, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Magnus Dalén, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Oscar E Simonson, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Uppsala University Hospital</name>
      <address>
        <city>Uppsala</city>
        <country>Sweden</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Laila Johansson Hellgren, MD, PhD</last_name>
    </contact>
    <investigator>
      <last_name>Laila Johansson Hellgren, MD, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>April 11, 2014</study_first_submitted>
  <study_first_submitted_qc>August 12, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 13, 2014</study_first_posted>
  <last_update_submitted>August 12, 2014</last_update_submitted>
  <last_update_submitted_qc>August 12, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 13, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Karolinska University Hospital</investigator_affiliation>
    <investigator_full_name>Karl-Henrik Grinnemo</investigator_full_name>
    <investigator_title>MD, PhD</investigator_title>
  </responsible_party>
  <keyword>Extracorporeal membrane oxygenation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Respiratory Distress Syndrome</mesh_term>
    <mesh_term>Respiratory Distress Syndrome, Newborn</mesh_term>
    <mesh_term>Acute Lung Injury</mesh_term>
    <mesh_term>Syndrome</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/NCT02215811
org study id: MSC-ARDS
nct id: NCT02215811
lead sponsor: 
collaborator: 
has dmc: No
This is a multi-center, open-label, non-randomized controlled trial. Patients with
      viral-induced acute respiratory distress syndrome (ARDS) on extracorporeal membrane
      oxygenation (ECMO) will be eligible. Ten patients will be enrolled and receive allogeneic
      bone marrow-derived mesenchymal stromal cells (BM-MSC). Ventilator parameters as well as
      preoperative clinical characteristics and postoperative clinical outcomes will be registered.
      Routine blood sampling, radiography, and bronchioalveolar lavage will be performed pre- and
      postoperatively. Spirometry, quality of life assessment, and 6 minute walk test will be
      performed postoperatively. All available data will be collected prospectively. Follow-up is
      12 months. Informed consent will be obtained from relatives to patients meeting the inclusion
      criteria before the initiation of any study-specific procedures.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: In-hospital mortality
time frame: During hospital stay, an expected average 2 months
measure: Pulmonary compliance
time frame: During ventilator treatment, an expected average of 1 month
measure: Pulmonary tidal volume
time frame: During ventilator treatment, an expected average of 1 month
measure: Adverse events
time frame: 6 months
description: I.e infection, fever, effect on end-organ function
measure: All-cause mortality
time frame: 12 months
measure: Recovery of organ functions
time frame: 12 months
description: kidney, liver, heart functions
measure: Immune modulation
time frame: 3 months
description: Change in T-cell, mononuclear cell, cytokine ans microRNA response towards an immunomodulatory phenotype
arm group label: Mesenchymal stromal cells
arm group type: Experimental
intervention type: Biological
intervention name: Mesenchymal stromal cells
arm group label: Mesenchymal stromal cells
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Karl-Henrik Grinnemo
role: Principal Investigator
affiliation: Karolinska Institutet
last name: Karl-Henrik Grinnemo, MD, PhD
phone: +46 70 886 89 68
email: karl-henrik.grinnemo@karolinska.se
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
investigator: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
country: Sweden
responsible party type: Principal Investigator
investigator affiliation: Karolinska University Hospital
investigator full name: Karl-Henrik Grinnemo
investigator title: MD, PhD
mesh term: Respiratory Distress Syndrome
mesh term: Respiratory Distress Syndrome, Newborn
mesh term: Acute Lung Injury
mesh term: Syndrome