<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/NCT03759405</url>
  </required_header>
  <id_info>
    <org_study_id>BUCM</org_study_id>
    <nct_id>NCT03759405</nct_id>
  </id_info>
  <brief_title>IPS Differentiated Cardiomyocytes Vein Transplantation for Chronic Heart Failure</brief_title>
  <acronym>IDCVTCHF</acronym>
  <official_title>Myocardial Cell Vein Transplantation for Chronic Heart Failure</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Beijing University of Chinese Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Dongzhimen Hospital, Beijing</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Beijing University of Chinese Medicine</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>
      Based on the safety evaluation of primates, the best cell transplantation scheme was&#xD;
      integrated. One patient with CHF caused by coronary heart disease, one patient with CHF&#xD;
      caused by dilatation and one patient with CHF caused by Keshan disease were selected and&#xD;
      treated with autologous iPS differentiated cardiomyocyte intravenous transplantation. The&#xD;
      safety evaluation of human body was completed and combined with subjective and objective&#xD;
      indexes respectively. Structural and functional indicators were used to evaluate the&#xD;
      therapeutic effect of cell transplantation. The results of animal experiments confirmed the&#xD;
      safety and effectiveness of intravenous myocardial cell transplantation, and clarified its&#xD;
      possible mechanism.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Not yet recruiting</overall_status>
  <start_date type="Anticipated">December 31, 2022</start_date>
  <completion_date type="Anticipated">December 31, 2024</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2024</primary_completion_date>
  <phase>Phase 2/Phase 3</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>Quality of life assessment</measure>
    <time_frame>6 months</time_frame>
    <description>Minnesota Heart Failure Scale for Quality of Life. Scale ranges (0-100), do higher values represent a worse outcome. The higher the score, the lower the quality of life.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Curative effect evaluation</measure>
    <time_frame>6 months</time_frame>
    <description>Cardiac Function Measurement by Cardiac Color Doppler Ultrasound. Under normal conditions, left ventricular ejection fraction is more than 50%. The lower ejection fraction, the worse heart function.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">3</enrollment>
  <condition>Chronic Heart Failure</condition>
  <arm_group>
    <arm_group_label>Chronic heart failure treatment group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>One case of CHF caused by coronary heart disease, one case of CHF caused by dilated heart disease and one case of CHF caused by Keshan disease were selected and treated with autologous iPS differentiated cardiomyocyte intravenous transplantation.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>iPS differentiated cardiomyocytes</intervention_name>
    <description>Repair of injured myocardium by vein transplantation with autologous iPS differentiated cardiomyocytes</description>
    <arm_group_label>Chronic heart failure treatment group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  It accords with the diagnostic standard of chronic heart failure.&#xD;
&#xD;
          -  The etiological diagnosis accords with the corresponding diagnostic standard.&#xD;
&#xD;
          -  The age is 30~80 years old.&#xD;
&#xD;
          -  Cardiac function classification is III- grade IV.&#xD;
&#xD;
          -  Signed informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Those who did not meet the diagnostic criteria and were included in the standard.&#xD;
&#xD;
          -  Patients with severe dyspnea (such as COPD with pulmonary encephalopathy, upper&#xD;
             gastrointestinal bleeding, etc.) accompanied by obvious hypoxemia and hemodynamic&#xD;
             instability.&#xD;
&#xD;
          -  Patients with severe primary diseases, such as liver and kidney diseases,&#xD;
             hematological diseases, autoimmune diseases, malignant tumors, progressive diseases or&#xD;
             diseases with poor prognosis, such as severe infection, severe water and electrolyte&#xD;
             disorders, acid-base imbalance.&#xD;
&#xD;
          -  Various infectious diseases.&#xD;
&#xD;
          -  Participants in other clinical trials in the past two months.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Beijing University of Chinese Medicine</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100029</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>July 2022</verification_date>
  <study_first_submitted>November 23, 2018</study_first_submitted>
  <study_first_submitted_qc>November 28, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 30, 2018</study_first_posted>
  <last_update_submitted>July 20, 2022</last_update_submitted>
  <last_update_submitted_qc>July 20, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">July 22, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Beijing University of Chinese Medicine</investigator_affiliation>
    <investigator_full_name>Anlong Xu</investigator_full_name>
    <investigator_title>professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Failure</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03759405
org study id: BUCM
nct id: NCT03759405
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Based on the safety evaluation of primates, the best cell transplantation scheme was
      integrated. One patient with CHF caused by coronary heart disease, one patient with CHF
      caused by dilatation and one patient with CHF caused by Keshan disease were selected and
      treated with autologous iPS differentiated cardiomyocyte intravenous transplantation. The
      safety evaluation of human body was completed and combined with subjective and objective
      indexes respectively. Structural and functional indicators were used to evaluate the
      therapeutic effect of cell transplantation. The results of animal experiments confirmed the
      safety and effectiveness of intravenous myocardial cell transplantation, and clarified its
      possible mechanism.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Quality of life assessment
time frame: 6 months
description: Minnesota Heart Failure Scale for Quality of Life. Scale ranges (0-100), do higher values represent a worse outcome. The higher the score, the lower the quality of life.
measure: Curative effect evaluation
time frame: 6 months
description: Cardiac Function Measurement by Cardiac Color Doppler Ultrasound. Under normal conditions, left ventricular ejection fraction is more than 50%. The lower ejection fraction, the worse heart function.
arm group label: Chronic heart failure treatment group
arm group type: Experimental
description: One case of CHF caused by coronary heart disease, one case of CHF caused by dilated heart disease and one case of CHF caused by Keshan disease were selected and treated with autologous iPS differentiated cardiomyocyte intravenous transplantation.
intervention type: Biological
intervention name: iPS differentiated cardiomyocytes
description: Repair of injured myocardium by vein transplantation with autologous iPS differentiated cardiomyocytes
arm group label: Chronic heart failure treatment group
criteria: 
gender: All
minimum age: 30 Years
maximum age: 80 Years
healthy volunteers: No
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Beijing University of Chinese Medicine
investigator full name: Anlong Xu
investigator title: professor
mesh term: Heart Failure
sharing ipd: No