<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/NCT01666132</url>
  </required_header>
  <id_info>
    <org_study_id>METHOD</org_study_id>
    <nct_id>NCT01666132</nct_id>
  </id_info>
  <brief_title>METHOD - Bone Marrow Derived Mononuclear Cells in Chronic Ischemic Disease</brief_title>
  <official_title>METHOD - Phase I/II Study of Intramyocardial Injection of Bone Marrow Derived Mononuclear Cells in Chronic Ischemic Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cardiocentro Ticino</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cardiocentro Ticino</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Intramyocardial, NOGA guided injection of bone marrow derived mononuclear cells in patients&#xD;
      with chronic ischemic heart disease and LVEF &lt; 40%. The primary objective is to determine&#xD;
      whether the administration of the cells improves recovery of the left ventricular function.&#xD;
      Secondary objective is the finding of clinical or paraclinical parameters to predict&#xD;
      potential benefits of the treatment (basing on MRI characteristics such as size,&#xD;
      transmurality of the myocardial infarction and peri-lesional ischemia).&#xD;
&#xD;
      In the first part of the study 10 patients are treated without control group. This phase&#xD;
      serves as feasibility and safety part of the study.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Due to the slow recruitment process and the progress of newer cell types we decided to stop the&#xD;
    trial after the phase 1 (after 10 patients included)&#xD;
  </why_stopped>
  <start_date>January 2011</start_date>
  <completion_date type="Actual">April 2015</completion_date>
  <primary_completion_date type="Actual">April 2015</primary_completion_date>
  <phase>Phase 1/Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Troponin samples</measure>
    <time_frame>1 day after cell injection</time_frame>
    <description>Measurements of Troponine after cell injection</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of patients with adverse events at short term</measure>
    <time_frame>within 1 week after cell injection</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of patients with adverse events at mid/long term</measure>
    <time_frame>up to 12 months after cell injection</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>change in LVEF</measure>
    <time_frame>6 months vs. baseline</time_frame>
    <description>First 10 patients + following randomization phase (n = 54); assessment of short term safety (1 week), Adverse events within 1 year; efficacy measurements 6 months after treatment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>change in Quality of life</measure>
    <time_frame>6 months vs. baseline</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>change in Vo2 max</measure>
    <time_frame>6 months vs. bl</time_frame>
    <description>change in functional status (Vo2 max)</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">10</enrollment>
  <condition>Chronic Ischemic Heart Disease</condition>
  <arm_group>
    <arm_group_label>Intramyocardial injection of BM cells</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Intramyocardial / intracoronary injection of BM cells</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>control</arm_group_label>
    <arm_group_type>Other</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>intramyocardial injection of BM cells</intervention_name>
    <description>only intramyocardial, NOGA guided injection on BM cells.</description>
    <arm_group_label>Intramyocardial injection of BM cells</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>intramyocardial / intracoronary injection of BM cells</intervention_name>
    <description>combination of intramyocardial, NOGA guided injection of BM cells and intracoronary injection of those cells</description>
    <arm_group_label>Intramyocardial / intracoronary injection of BM cells</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Best medical therapy</intervention_name>
    <description>initially no intervention; crossover to therapy 6 months after enrollment</description>
    <arm_group_label>control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Chronic cardiac ischemic disease at least 4 months after one ore more myocardial&#xD;
             infarctions in a stable phase of the disease without option for revascularization&#xD;
&#xD;
          -  LVEF at echocardiography ≤ 40%&#xD;
&#xD;
          -  Significant regional LV wall motion dysfunction in the infarct related territory&#xD;
&#xD;
          -  Symptoms NYHA II-IV or CCS II-III (at least class III according to one of the two&#xD;
             classifications)&#xD;
&#xD;
          -  Patient agrees to comply with all follow-up evaluations&#xD;
&#xD;
          -  Age &gt; 18 years old&#xD;
&#xD;
          -  Patient has been informed of the nature of the clinical trial and agrees to its&#xD;
             provision and has provided written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Abnormal regional wall motion outside the infarct region&#xD;
&#xD;
          -  Need for revascularization in a non infarct-related coronary within 6 months&#xD;
&#xD;
          -  Patient has moderate to severe aortic valve disease, aortic or mitral prosthetic valve&#xD;
&#xD;
          -  Patient has a significant mitral valve insufficiency (Effective Regurgitant office -&#xD;
             ERO - &gt; 0.2 cm2 with possibility of mitral valve surgery&#xD;
&#xD;
          -  Left ventricular thrombus at echocardiography&#xD;
&#xD;
          -  LV-aneurysma planned surgical aneurysmectomy&#xD;
&#xD;
          -  LV-wall thickness &lt; 5mm in the target territory&#xD;
&#xD;
          -  Congenital heart disorder of hemodynamic relevance&#xD;
&#xD;
          -  Known active infection or chronic infection with HIV, HBV or HCV&#xD;
&#xD;
          -  Chronic inflammatory disease&#xD;
&#xD;
          -  Serious concomitant disease with a life expectancy of less than one year&#xD;
&#xD;
          -  Follow up impossible (no fixed abode, etc)&#xD;
&#xD;
          -  Contraindication for cardiac MRI (i.e. pace maker, neurostimulator, claustrophobia)&#xD;
&#xD;
          -  Severe renal failure (creatinine &gt; 250 mmol/l)&#xD;
&#xD;
          -  Relevant liver disease (GOT &gt; 2x norm or spontaneous INR &gt; 1,5)&#xD;
&#xD;
          -  Anemia (Hb &lt; 8.5 mg/dl), Thrombocytopenia (&lt; 100.000/µl)&#xD;
&#xD;
          -  Women of child bearing potential or pregnancy&#xD;
&#xD;
          -  Participation at a clinical trial in the last 30 days&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Cardiocentro Ticino</name>
      <address>
        <city>Lugano</city>
        <zip>6900</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>August 2015</verification_date>
  <study_first_submitted>June 27, 2011</study_first_submitted>
  <study_first_submitted_qc>August 15, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 16, 2012</study_first_posted>
  <last_update_submitted>August 19, 2015</last_update_submitted>
  <last_update_submitted_qc>August 19, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 20, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cardiocentro Ticino</investigator_affiliation>
    <investigator_full_name>Daniel Suerder</investigator_full_name>
    <investigator_title>MD; senior attendant of Cardiology</investigator_title>
  </responsible_party>
  <keyword>LVEF &lt; 40%</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Diseases</mesh_term>
    <mesh_term>Myocardial Ischemia</mesh_term>
    <mesh_term>Coronary Artery Disease</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/NCT01666132
org study id: METHOD
nct id: NCT01666132
lead sponsor: 
has dmc: No
Intramyocardial, NOGA guided injection of bone marrow derived mononuclear cells in patients
      with chronic ischemic heart disease and LVEF < 40%. The primary objective is to determine
      whether the administration of the cells improves recovery of the left ventricular function.
      Secondary objective is the finding of clinical or paraclinical parameters to predict
      potential benefits of the treatment (basing on MRI characteristics such as size,
      transmurality of the myocardial infarction and peri-lesional ischemia).

      In the first part of the study 10 patients are treated without control group. This phase
      serves as feasibility and safety part of the study.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Troponin samples
time frame: 1 day after cell injection
description: Measurements of Troponine after cell injection
measure: Number of patients with adverse events at short term
time frame: within 1 week after cell injection
measure: Number of patients with adverse events at mid/long term
time frame: up to 12 months after cell injection
measure: change in LVEF
time frame: 6 months vs. baseline
description: First 10 patients + following randomization phase (n = 54); assessment of short term safety (1 week), Adverse events within 1 year; efficacy measurements 6 months after treatment
measure: change in Quality of life
time frame: 6 months vs. baseline
measure: change in Vo2 max
time frame: 6 months vs. bl
description: change in functional status (Vo2 max)
arm group label: Intramyocardial injection of BM cells
arm group type: Experimental
arm group label: Intramyocardial / intracoronary injection of BM cells
arm group type: Experimental
arm group label: control
arm group type: Other
intervention type: Other
intervention name: intramyocardial injection of BM cells
description: only intramyocardial, NOGA guided injection on BM cells.
arm group label: Intramyocardial injection of BM cells
intervention type: Other
intervention name: intramyocardial / intracoronary injection of BM cells
description: combination of intramyocardial, NOGA guided injection of BM cells and intracoronary injection of those cells
arm group label: Intramyocardial / intracoronary injection of BM cells
intervention type: Other
intervention name: Best medical therapy
description: initially no intervention; crossover to therapy 6 months after enrollment
arm group label: control
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Switzerland
responsible party type: Principal Investigator
investigator affiliation: Cardiocentro Ticino
investigator full name: Daniel Suerder
investigator title: MD; senior attendant of Cardiology
mesh term: Heart Diseases
mesh term: Myocardial Ischemia
mesh term: Coronary Artery Disease
mesh term: Ischemia