<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/NCT03227198</url>
  </required_header>
  <id_info>
    <org_study_id>SCARM-Heart-002</org_study_id>
    <nct_id>NCT03227198</nct_id>
  </id_info>
  <brief_title>IMMNC-HF: IntraMyocardial Injection of Bone Marrow MonoNuclear Cells in Heart Failure (HF) Patients</brief_title>
  <acronym>IMMNC-HF</acronym>
  <official_title>Evaluation of the Intramyocardial Injection of Autologous Bone Marrow Derived Mononuclear Stem Cells in Heart Failure (HF) Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>SCARM Institute, Tabriz, Iran</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>SCARM Institute, Tabriz, Iran</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 prospective, randomised double blind, controlled, parallel-group phase I and II&#xD;
      study. Its aim is to assess the Evaluation of the intramyocardial injection of autologous&#xD;
      bone marrow derived mononuclear stem cells is safe and effective in hear failure patients&#xD;
      with reduced left ventricular ejection fraction(&lt;=30%) when compared to a control group of&#xD;
      patients undergoing best medical care.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">October 14, 2020</start_date>
  <completion_date type="Anticipated">October 12, 2021</completion_date>
  <primary_completion_date type="Anticipated">August 10, 2021</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>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Death</measure>
    <time_frame>12 months</time_frame>
    <description>The rate of patients mortality after transplantation</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Hospitalization</measure>
    <time_frame>12 months</time_frame>
    <description>the rate of hospitalization after transplantation</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Ejection fraction changes</measure>
    <time_frame>12 months</time_frame>
    <description>Elevation of ejection fraction in patients after transplantation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>6-minute walk test (6MWT)</measure>
    <time_frame>12 months</time_frame>
    <description>Evaluation the improvement of 6MWT test after transplantation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pro b-type natriuretic peptide (Pro-BNP) changes</measure>
    <time_frame>12 months</time_frame>
    <description>Elevation the reduction of Pro-BNP in patients after transplantation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>NYHA functional class</measure>
    <time_frame>12 months</time_frame>
    <description>Evaluation the improvement of NYHA functional class in patients</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">5</enrollment>
  <condition>Heart Failure</condition>
  <arm_group>
    <arm_group_label>Intramyocardial injection of stem cell</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intramyocardial injection of autologous bone marrow mononuclear cells in patients with Heart Failure</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo intramyocardial injection in patients with Heart Failure</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Intramyocardial injection of stem cell</intervention_name>
    <description>Autologous bone marrow-derived mononuclear cells are obtained from 100-150ml of bone marrow aspirated under local anaesthesia from the iliac crest. Intramyocardial injection of the cells is performed in patients with Heart failure in open heart surgery (CABG)</description>
    <arm_group_label>Intramyocardial injection of stem cell</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Injection of Placebo in patients with Heart failure in open heart surgery (CABG)</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Men and women of any ethnic origin 18 ≤ aged≤ 65 years&#xD;
&#xD;
          2. EF≤40 (by Echocardiography) and regional wall motion abnormality&#xD;
&#xD;
          3. Not responding to standard therapies&#xD;
&#xD;
          4. the New York Heart Association (NYHA) class ≥ III&#xD;
&#xD;
          5. Myocardial infarction due to coronary artery atherosclerotic disease&#xD;
&#xD;
          6. An area of regional dysfunction, i.e., hypokinetic, akinetic, or dyskinetic&#xD;
             (echocardiography or MRI)&#xD;
&#xD;
          7. Normal liver and renal function&#xD;
&#xD;
          8. No or controlled diabetes&#xD;
&#xD;
          9. Able to give voluntary written consent and understand the study information provided&#xD;
             to him&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Participation in another clinical trial within 30 days prior randomisation&#xD;
&#xD;
          2. Previously received stem/progenitor cell therapy&#xD;
&#xD;
          3. Pregnant women&#xD;
&#xD;
          4. Mental condition rendering the patient unable to understand the nature, scope and&#xD;
             possible consequences of the study or to follow the protocol&#xD;
&#xD;
          5. Cardiogenic shock requiring mechanical support&#xD;
&#xD;
          6. Congenital / valvular heart disease&#xD;
&#xD;
          7. Implantable cardioverter defibrillator (ICD) transplant&#xD;
&#xD;
          8. Platelet count &lt;100.000/µl, or hemoglobin &lt;8.5 g/dl&#xD;
&#xD;
          9. Impaired renal function, i.e. creatinine &gt;2.5 mg/dl&#xD;
&#xD;
         10. Fever or diarrhea within 4 weeks prior screening&#xD;
&#xD;
         11. History of bleeding disorder within 3 months prior screening&#xD;
&#xD;
         12. Uncontrolled hypertension (systolic &gt;180 mmHg and diastolic &gt;120 mmHg) or Sustained&#xD;
             ventricular arrhythmia&#xD;
&#xD;
         13. Life expectancy of less than two years from any non-cardiac cause or uncontrolled&#xD;
             neoplastic disease&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Nasser Safaie, CTS</last_name>
    <role>Study Director</role>
    <affiliation>Tabriz University of Medical Sciences</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Mohammad Nouri, Ph.D</last_name>
    <role>Study Chair</role>
    <affiliation>Head of SCARM institute</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Peyman Keyhanvar, MD, Ph.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>Deputy for translational medicine of SCARM institute</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Raheleh Farahzadi, Ph.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>Cardiovascular research center, Tabriz University of Medical Sciences, Tabriz, Iran</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Yousef Faridvand, Ph.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>SCARM institute</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Elgar Anamzadeh, MD, Cardiologist</last_name>
    <role>Principal Investigator</role>
    <affiliation>Tabriz University of Medical Sciences</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Nasser Safaie, CTS</last_name>
    <phone>0413 33349525</phone>
    <email>drsafaie@yahoo.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Peyman Keyhanvar, MD, Ph.D</last_name>
    <phone>0413 33349525</phone>
    <email>drkeyhanvar@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Stem Cell And Regenerative Medicine institute (SCARM)</name>
      <address>
        <city>Tabriz</city>
        <country>Iran, Islamic Republic of</country>
      </address>
    </facility>
    <contact>
      <last_name>Peyman Keyhanvar, MD, Ph.D</last_name>
      <phone>0914 114 6863</phone>
    </contact>
    <investigator>
      <last_name>Yousef Faridvand, Ph.D</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Iran, Islamic Republic of</country>
  </location_countries>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>July 21, 2017</study_first_submitted>
  <study_first_submitted_qc>July 21, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 24, 2017</study_first_posted>
  <last_update_submitted>October 24, 2020</last_update_submitted>
  <last_update_submitted_qc>October 24, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 27, 2020</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>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/NCT03227198
org study id: SCARM-Heart-002
nct id: NCT03227198
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This is a prospective, randomised double blind, controlled, parallel-group phase I and II
      study. Its aim is to assess the Evaluation of the intramyocardial injection of autologous
      bone marrow derived mononuclear stem cells is safe and effective in hear failure patients
      with reduced left ventricular ejection fraction(<=30%) when compared to a control group of
      patients undergoing best medical care.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Death
time frame: 12 months
description: The rate of patients mortality after transplantation
measure: Hospitalization
time frame: 12 months
description: the rate of hospitalization after transplantation
measure: Ejection fraction changes
time frame: 12 months
description: Elevation of ejection fraction in patients after transplantation
measure: 6-minute walk test (6MWT)
time frame: 12 months
description: Evaluation the improvement of 6MWT test after transplantation
measure: Pro b-type natriuretic peptide (Pro-BNP) changes
time frame: 12 months
description: Elevation the reduction of Pro-BNP in patients after transplantation
measure: NYHA functional class
time frame: 12 months
description: Evaluation the improvement of NYHA functional class in patients
arm group label: Intramyocardial injection of stem cell
arm group type: Experimental
description: Intramyocardial injection of autologous bone marrow mononuclear cells in patients with Heart Failure
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo intramyocardial injection in patients with Heart Failure
intervention type: Biological
intervention name: Intramyocardial injection of stem cell
description: Autologous bone marrow-derived mononuclear cells are obtained from 100-150ml of bone marrow aspirated under local anaesthesia from the iliac crest. Intramyocardial injection of the cells is performed in patients with Heart failure in open heart surgery (CABG)
arm group label: Intramyocardial injection of stem cell
intervention type: Biological
intervention name: Placebo
description: Injection of Placebo in patients with Heart failure in open heart surgery (CABG)
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Nasser Safaie, CTS
role: Study Director
affiliation: Tabriz University of Medical Sciences
last name: Mohammad Nouri, Ph.D
role: Study Chair
affiliation: Head of SCARM institute
last name: Peyman Keyhanvar, MD, Ph.D
role: Principal Investigator
affiliation: Deputy for translational medicine of SCARM institute
last name: Raheleh Farahzadi, Ph.D
role: Principal Investigator
affiliation: Cardiovascular research center, Tabriz University of Medical Sciences, Tabriz, Iran
last name: Yousef Faridvand, Ph.D
role: Principal Investigator
affiliation: SCARM institute
last name: Elgar Anamzadeh, MD, Cardiologist
role: Principal Investigator
affiliation: Tabriz University of Medical Sciences
last name: Nasser Safaie, CTS
phone: 0413 33349525
email: drsafaie@yahoo.com
last name: Peyman Keyhanvar, MD, Ph.D
phone: 0413 33349525
email: drkeyhanvar@gmail.com
facility: 
contact: 
investigator: 
country: Iran, Islamic Republic of
responsible party type: Sponsor
mesh term: Heart Failure
sharing ipd: No