<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/NCT01709279</url>
  </required_header>
  <id_info>
    <org_study_id>1133</org_study_id>
    <nct_id>NCT01709279</nct_id>
  </id_info>
  <brief_title>Clinical Trial of Autologous Adipose Tissue Derived Stromal Cell Therapy for Ischemic Heart Failure</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kanazawa University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Kanazawa University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Mesenchymal stem cells have capability to differentiate into myocardium, vascular endothelial&#xD;
      cell, vascular smooth muscle cell and will be useful for heart regeneration. Adipose tissue&#xD;
      is relatively enriched with mesenchymal stem cell compared to bone marrow tissue. In this&#xD;
      trial, eligible ischemic heart failure patients will be proceeded intracoronary&#xD;
      administration of autologous adipose tissue derived stromal cells by cardiac catheterization.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The population of the ischemic heart failure patients is enormous in Japan and the only&#xD;
      radical treatment for them is heart transplantation: however, the number of giving donor is&#xD;
      extremely limited. Mesenchymal stem cells have been capable to differentiate into&#xD;
      mesodermal-lineage cells as well as endodermal-lineage cells such as myocardial cell. They&#xD;
      reside in the mesenchymal tissues such as bone marrows as well as adipose tissues. The latter&#xD;
      tissues are relatively enriched with mesenchymal stem cells compared to bone marrow cells. In&#xD;
      this study, the ischemic heart failure patients will undergo intracoronary administration of&#xD;
      autologous adipose tissue derived stromal cells through cardiac catheterization.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Enrolling by invitation</last_known_status>
  <start_date>August 2012</start_date>
  <completion_date type="Anticipated">September 2019</completion_date>
  <primary_completion_date type="Anticipated">August 2019</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>all cause harmful events</measure>
    <time_frame>6 month</time_frame>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">6</enrollment>
  <condition>Ischemic Heart Failure</condition>
  <arm_group>
    <arm_group_label>adipose tissue derived stromal cells</arm_group_label>
    <arm_group_type>Other</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>adipose tissue derived stromal cells dosage</intervention_name>
    <description>intra-coronary administration of autologous adipose tissue derived stroma cells</description>
    <arm_group_label>adipose tissue derived stromal cells</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Heart failure patients occured by prior ischemic event whose ejection fraction must be&#xD;
             less than 40%.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Complicated severe other organ disease.&#xD;
&#xD;
          -  Patient with malignancy.&#xD;
&#xD;
          -  History of chemotherapy or irradiation within 4 weeks.&#xD;
&#xD;
          -  Patient with immunodeficiency&#xD;
&#xD;
          -  Pregnancy or possibility of pregnancy&#xD;
&#xD;
          -  Candidate who are judged to be not applicable to this study by doctors.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Kanazawa University Hospital</name>
      <address>
        <city>Kanazawa</city>
        <state>Ishikawa</state>
        <zip>920-8641</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Japan</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>October 16, 2012</study_first_submitted>
  <study_first_submitted_qc>October 16, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 18, 2012</study_first_posted>
  <last_update_submitted>August 15, 2017</last_update_submitted>
  <last_update_submitted_qc>August 15, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 18, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Kanazawa University</investigator_affiliation>
    <investigator_full_name>Shuichi Kaneko</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Ischemic heart failure</keyword>
  <keyword>Myocardial regeneration</keyword>
  <keyword>ADRC</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Failure</mesh_term>
    <mesh_term>Ischemia</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/NCT01709279
org study id: 1133
nct id: NCT01709279
lead sponsor: 
has dmc: No
Mesenchymal stem cells have capability to differentiate into myocardium, vascular endothelial
      cell, vascular smooth muscle cell and will be useful for heart regeneration. Adipose tissue
      is relatively enriched with mesenchymal stem cell compared to bone marrow tissue. In this
      trial, eligible ischemic heart failure patients will be proceeded intracoronary
      administration of autologous adipose tissue derived stromal cells by cardiac catheterization.
The population of the ischemic heart failure patients is enormous in Japan and the only
      radical treatment for them is heart transplantation: however, the number of giving donor is
      extremely limited. Mesenchymal stem cells have been capable to differentiate into
      mesodermal-lineage cells as well as endodermal-lineage cells such as myocardial cell. They
      reside in the mesenchymal tissues such as bone marrows as well as adipose tissues. The latter
      tissues are relatively enriched with mesenchymal stem cells compared to bone marrow cells. In
      this study, the ischemic heart failure patients will undergo intracoronary administration of
      autologous adipose tissue derived stromal cells through cardiac catheterization.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: all cause harmful events
time frame: 6 month
arm group label: adipose tissue derived stromal cells
arm group type: Other
intervention type: Biological
intervention name: adipose tissue derived stromal cells dosage
description: intra-coronary administration of autologous adipose tissue derived stroma cells
arm group label: adipose tissue derived stromal cells
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Japan
responsible party type: Principal Investigator
investigator affiliation: Kanazawa University
investigator full name: Shuichi Kaneko
investigator title: Professor
mesh term: Heart Failure
mesh term: Ischemia