<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/NCT04421274</url>
  </required_header>
  <id_info>
    <org_study_id>ScPHFPC-100306</org_study_id>
    <nct_id>NCT04421274</nct_id>
  </id_info>
  <brief_title>Bone Marrow Mesenchymal Stem Cells Transfer in Patients With ST-segment Elevation Myocardial Infarction</brief_title>
  <acronym>Bmmsct</acronym>
  <official_title>Bone Marrow Mesenchymal Stem Cells Transfer in Patients With ST-segment Elevation Myocardial Infarction: Single-blind, Randomized Controlled Muticentre Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Afﬁliated Hospital of North Sichuan Medical College</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Chinese PLA General Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Peking Union Medical College Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Beijing Tongren Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Afﬁliated Hospital of North Sichuan Medical College</source>
  <oversight_info>
    <has_dmc>No</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>
      To investigate the effect and safety of intracoronary autologous bone morrow mesenchymal stem&#xD;
      cells (BM-MSCs) transplantation in patients with ST-segment elevation myocardial infarction（&#xD;
      STEMI） .&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      To investigate the safety of intra-coronary injection of autologous bone marrow mesenchymal&#xD;
      stem cells (BM-MSCs) in patients with ST-segment elevation myocardial infarction and its&#xD;
      effect on cardiac function and viable myocardium. We plan to include approximately 40&#xD;
      patients with ST-segment elevation myocardial infarction as a research object, and conduct a&#xD;
      randomized, single-blind, parallel-controlled multi-center clinical trial. The patients were&#xD;
      randomly divided into a BM-MSCs group and a control group, and were given the best drug&#xD;
      treatment and percutaneous coronary intervention (PCI). The primary study endpoint was the&#xD;
      change in myocardial metabolic activity 6 months after autologous BM-MSCs transplantation and&#xD;
      the change in left ventricular ejection fraction (LVEF) at 12 months; The incidence of&#xD;
      adverse events. The above indexes were evaluated by cardiac color echocardiography and single&#xD;
      photon emission computed tomography (SPECT).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 1, 2008</start_date>
  <completion_date type="Actual">July 15, 2011</completion_date>
  <primary_completion_date type="Actual">July 10, 2010</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>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>changes in myocardial metabolic activity</measure>
    <time_frame>Baseline + after 6 months</time_frame>
    <description>changes in myocardial metabolic activity 6 months after transplantation of autologous BM-MSCs (SPET assay)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in left ventricular ejection fraction (LVEF)</measure>
    <time_frame>Baseline + after 12 months</time_frame>
    <description>Changes in left ventricular ejection fraction (LVEF) at 12 months after transplantation of autologous BM-MSCs.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>incidence of cardiovascular events</measure>
    <time_frame>in 12 months after transplantation of autologous BM-MSCs</time_frame>
    <description>incidence of cardiovascular events</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>overall mortality</measure>
    <time_frame>in 12 months after transplantation of autologous BM-MSCs</time_frame>
    <description>overall mortality</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>adverse events at 12 months after transplantation of autologous BM-MSCs</measure>
    <time_frame>in 12 months after transplantation of autologous BM-MSCs</time_frame>
    <description>adverse events at 12 months after transplantation of autologous BM-MSCs</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">43</enrollment>
  <condition>Myocardial Infarction</condition>
  <arm_group>
    <arm_group_label>BM-MSCs group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Receive the best medication, percutaneous coronary intervention, and bone marrow mesenchymal stem cells transfer(Intracoronary artery )</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Receive the best medication, percutaneous coronary intervention</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Bone marrow mesenchymal stem cells transfer</intervention_name>
    <description>Inject the BM-MSCs into the infarct-related arterial hypertension through the central cavity of the guide wire balloon catheter under the complete blockage of the target blood vessel. Each time the balloon continues to fill for 2 minutes to block blood flow, then resume perfusion for 2 minutes. The above process is repeated 6 ~ 8 times</description>
    <arm_group_label>BM-MSCs group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Best medical treatment</intervention_name>
    <description>Refer to the latest medication guidelines and give the best medication to the patients</description>
    <arm_group_label>BM-MSCs group</arm_group_label>
    <arm_group_label>Control group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Percutaneous coronary intervention</intervention_name>
    <description>Percutaneous coronary intervention</description>
    <arm_group_label>BM-MSCs group</arm_group_label>
    <arm_group_label>Control group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age&gt; 18 years old;&#xD;
&#xD;
          -  Diagnosed acute ST-elevation myocardial infarction (STEMI)&#xD;
&#xD;
          -  STEMI onset &lt;1 month&#xD;
&#xD;
          -  Successful vascular remodeling, blood flow of infarct-related blood vessels recovered&#xD;
             to TIMI level 3&#xD;
&#xD;
          -  All patients included in the study signed an informed consent form and promised to&#xD;
             complete all follow-up plans&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Refractory persistent ventricular tachycardia&#xD;
&#xD;
          -  High cardiac block and no pacemaker control&#xD;
&#xD;
          -  Liver or renal dysfunction (ALT&gt;80U/ L, Cr&gt; 440mmol / L)&#xD;
&#xD;
          -  Bleeding disorders, malignant tumors&#xD;
&#xD;
          -  Autoimmune disease or any serious fatal disease&#xD;
&#xD;
          -  Contraindications for coronary intervention&#xD;
&#xD;
          -  Combined with other heart disease: congenital heart Disease (ventricular deficiency,&#xD;
             atrial deficient, patent ductus arteriosus and other congenital alformations),primary&#xD;
             valvular disease, active myocarditis, pulmonary heart disease,hyperthyroidism, mucous&#xD;
             edema heart disease and so on&#xD;
&#xD;
          -  Mental illness, no self-awareness, and no precise expression and cooperation&#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>The Third Hospital of Mianyang</name>
      <address>
        <city>Mianyang</city>
        <state>Sichuan</state>
        <zip>0816</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>May 14, 2020</study_first_submitted>
  <study_first_submitted_qc>June 5, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 9, 2020</study_first_posted>
  <last_update_submitted>June 5, 2020</last_update_submitted>
  <last_update_submitted_qc>June 5, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 9, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Myocardial infarction</keyword>
  <keyword>Mesenchymal stem cells</keyword>
  <keyword>Bone marrow</keyword>
  <keyword>Stem cells transplantation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Myocardial Infarction</mesh_term>
    <mesh_term>ST Elevation Myocardial Infarction</mesh_term>
    <mesh_term>Infarction</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Unfortunately, the research data is not shared</ipd_description>
  </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/NCT04421274
org study id: ScPHFPC-100306
nct id: NCT04421274
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
To investigate the effect and safety of intracoronary autologous bone morrow mesenchymal stem
      cells (BM-MSCs) transplantation in patients with ST-segment elevation myocardial infarction（
      STEMI） .
To investigate the safety of intra-coronary injection of autologous bone marrow mesenchymal
      stem cells (BM-MSCs) in patients with ST-segment elevation myocardial infarction and its
      effect on cardiac function and viable myocardium. We plan to include approximately 40
      patients with ST-segment elevation myocardial infarction as a research object, and conduct a
      randomized, single-blind, parallel-controlled multi-center clinical trial. The patients were
      randomly divided into a BM-MSCs group and a control group, and were given the best drug
      treatment and percutaneous coronary intervention (PCI). The primary study endpoint was the
      change in myocardial metabolic activity 6 months after autologous BM-MSCs transplantation and
      the change in left ventricular ejection fraction (LVEF) at 12 months; The incidence of
      adverse events. The above indexes were evaluated by cardiac color echocardiography and single
      photon emission computed tomography (SPECT).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: changes in myocardial metabolic activity
time frame: Baseline + after 6 months
description: changes in myocardial metabolic activity 6 months after transplantation of autologous BM-MSCs (SPET assay)
measure: Changes in left ventricular ejection fraction (LVEF)
time frame: Baseline + after 12 months
description: Changes in left ventricular ejection fraction (LVEF) at 12 months after transplantation of autologous BM-MSCs.
measure: incidence of cardiovascular events
time frame: in 12 months after transplantation of autologous BM-MSCs
description: incidence of cardiovascular events
measure: overall mortality
time frame: in 12 months after transplantation of autologous BM-MSCs
description: overall mortality
measure: adverse events at 12 months after transplantation of autologous BM-MSCs
time frame: in 12 months after transplantation of autologous BM-MSCs
description: adverse events at 12 months after transplantation of autologous BM-MSCs
arm group label: BM-MSCs group
arm group type: Experimental
description: Receive the best medication, percutaneous coronary intervention, and bone marrow mesenchymal stem cells transfer(Intracoronary artery )
arm group label: Control group
arm group type: Sham Comparator
description: Receive the best medication, percutaneous coronary intervention
intervention type: Biological
intervention name: Bone marrow mesenchymal stem cells transfer
description: Inject the BM-MSCs into the infarct-related arterial hypertension through the central cavity of the guide wire balloon catheter under the complete blockage of the target blood vessel. Each time the balloon continues to fill for 2 minutes to block blood flow, then resume perfusion for 2 minutes. The above process is repeated 6 ~ 8 times
arm group label: BM-MSCs group
intervention type: Drug
intervention name: Best medical treatment
description: Refer to the latest medication guidelines and give the best medication to the patients
arm group label: BM-MSCs group
arm group label: Control group
intervention type: Procedure
intervention name: Percutaneous coronary intervention
description: Percutaneous coronary intervention
arm group label: BM-MSCs group
arm group label: Control group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: China
responsible party type: Sponsor
mesh term: Myocardial Infarction
mesh term: ST Elevation Myocardial Infarction
mesh term: Infarction
sharing ipd: No
ipd description: Unfortunately, the research data is not shared