<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/NCT03272191</url>
  </required_header>
  <id_info>
    <org_study_id>ADI-ME-SMI-001</org_study_id>
    <nct_id>NCT03272191</nct_id>
  </id_info>
  <brief_title>Study to Assess Safety &amp; Effects of Autologous ADSCs During Recovery Phase of ST-Elevation MI Effects of Autologous ADSC Implantation During Subacute Recovery Phase of ST-Elevation Myocardial Infarction</brief_title>
  <official_title>An Open-label, Non-Randomized, Multi-Center Study to Assess the Safety and Cardiovascular Effects of Autologous ADSC Implantation by a Catheter Delivery System In Patients During the Subacute Recovery Phase of ST-Elevation MI</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ageless Regenerative Institute</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ageless Regenerative Institute</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The intent of this clinical study is to answer the questions: 1) Is the proposed treatment&#xD;
      safe? and 2) Is treatment effective in improving cardiac function and clinical outcomes?&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This will be an open-label, non-randomized multi-center study of ASC implantation using a&#xD;
      catheter delivery system. ASCs will be derived from the patient's adipose-derived tissue.&#xD;
      Liposuction will be performed to collect the adipose tissue specimen for subsequent&#xD;
      processing to isolate the stem cells. The injection catheter will be used for delivery of the&#xD;
      ASCs therapy.&#xD;
&#xD;
      The adipose tissue specimen will be collected mainly from the patient's abdomen using a&#xD;
      liposuction cannula. The adipose tissue may be collected from other areas if necessary The&#xD;
      adipose tissue is transferred to the laboratory for separation of the adipose tissue-derived&#xD;
      stem cells, which are then transferred to an injection/infusion catheter for delivery into&#xD;
      the akinetic myocardial scar in the region of a previous infarct&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    company dissolved&#xD;
  </why_stopped>
  <start_date>September 2016</start_date>
  <completion_date type="Anticipated">December 2018</completion_date>
  <primary_completion_date type="Anticipated">September 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Improved cardiac function</measure>
    <time_frame>3 and 6 months after intervention</time_frame>
    <description>Improvement is observed in cardiac function as assessed by echocardiographic LV function (EF)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Adverse Event</measure>
    <time_frame>Duration of study</time_frame>
    <description>The safety of adipose-derived stem cell injection will be evaluated by assessment of the frequency and nature of adverse events occurring during the study injection and up to the 6-month period following treatment.</description>
  </secondary_outcome>
  <enrollment type="Actual">0</enrollment>
  <condition>Subacute Myocardial Infarction</condition>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Liposuction and stem cell implantation</intervention_name>
    <description>The adipose tissue specimen will be collected mainly from the patient's abdomen using a liposuction cannula. The adipose tissue may be collected from other areas if necessary The adipose tissue is transferred to the laboratory for separation of the adipose tissue-derived stem cells, which are then transferred to an injection/infusion catheter for delivery into the akinetic myocardial scar in the region of a previous infarct</description>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Males and Females between Age 18 and 80 years.&#xD;
&#xD;
          -  Defined subacute myocardial infarction between 9-90 days from screening&#xD;
&#xD;
          -  Left ventricular ejection fraction at screening of ≤ 50%, with 2 or more contiguous&#xD;
             areas of severe wall motion abnormality on resting echocardiography.&#xD;
&#xD;
          -  Patients must have a minimum myocardial wall thickness of 5mm&#xD;
&#xD;
          -  Need or feasibility for re-vascularization has been ruled out by coronary angiogram or&#xD;
             noninvasive stress testing.&#xD;
&#xD;
          -  Stable for at least 14 days on optimal medical management including:&#xD;
&#xD;
          -  Plavix/asprin therapy, anticoagulation therapy, cholesterol lowering agent, beta&#xD;
             blocker, ACE inhibitor or ARB blocker Up to date on all age and gender appropriate&#xD;
             cancer screening per American Cancer Society (Refer to section 9.3 for more details).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Females who are pregnant or nursing or females of childbearing potential who are&#xD;
             unwilling to maintain contraceptive therapy for the duration of the study&#xD;
&#xD;
          -  Life expectancy &lt; 6 months due to concomitant illnesses.&#xD;
&#xD;
          -  NYHA CHF Class 4&#xD;
&#xD;
          -  Severe valvular or other non-ischemic myocardial disease.&#xD;
&#xD;
          -  Mechanical complications of the index acute myocardial infarction including but not&#xD;
             limited to rupture of the mitral valve with resultant development of mitral&#xD;
             regurgitation, rupture of the left ventricular free wall and rupture of the&#xD;
             interventricular septum.&#xD;
&#xD;
          -  Previous severe reaction to radiocontrast agents&#xD;
&#xD;
          -  Exposure to any investigational drug or procedure within 1 month prior to study entry&#xD;
             or enrolled in a concurrent study that may confound results of this study.&#xD;
&#xD;
          -  Serum creatinine &gt; 2.5 mg/dL or end stage renal disease unless on dialysis.&#xD;
&#xD;
          -  Active infectious disease and/or known to have tested positive for HIV, HTLV, HBV,&#xD;
             HCV, CMV (IgM &gt; IgG) and/or syphilis. If the panel includes antibodies to the HBV-cAg&#xD;
             and HBV-sAg, then an expert will be consulted as to patient eligibility based on the&#xD;
             patient's infectious status&#xD;
&#xD;
          -  Any illness which, in the Investigator's judgment, will interfere with the patient's&#xD;
             ability to comply with the protocol, compromise patient safety, or interfere with the&#xD;
             interpretation of the study results&#xD;
&#xD;
          -  Patients on chronic immunosuppressive transplant therapy&#xD;
&#xD;
          -  Systolic blood pressure (supine) ≤90 mmHg;&#xD;
&#xD;
          -  Resting heart rate &gt; 100 bpm;&#xD;
&#xD;
          -  Active clinical infection within one week of enrollment.&#xD;
&#xD;
          -  Cerebrovascular accident within 6 months prior to study entry&#xD;
&#xD;
          -  Known drug or alcohol dependence or any other factors which will interfere with the&#xD;
             study conduct or interpretation of the results or who in the opinion of the&#xD;
             investigator are not suitable to participate.&#xD;
&#xD;
          -  History of cancer (other than non-melanoma skin cancer or in-situ cervical cancer) in&#xD;
             the last five years.&#xD;
&#xD;
          -  Unwilling and/or not able to give written informed consent.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sharon McQuillan, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ageless Regenerative Institute</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Ageless Regenerative Institute LLC</name>
      <address>
        <city>Aventura</city>
        <state>Florida</state>
        <zip>33180</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>October 28, 2013</study_first_submitted>
  <study_first_submitted_qc>August 31, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 5, 2017</study_first_posted>
  <last_update_submitted>August 31, 2017</last_update_submitted>
  <last_update_submitted_qc>August 31, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 5, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>MI</keyword>
  <keyword>Infarction</keyword>
  <keyword>Infarct</keyword>
  <keyword>Subacute MI</keyword>
  <keyword>stem cell</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Myocardial Infarction</mesh_term>
    <mesh_term>Infarction</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/NCT03272191
org study id: ADI-ME-SMI-001
nct id: NCT03272191
lead sponsor: 
has dmc: No
The intent of this clinical study is to answer the questions: 1) Is the proposed treatment
      safe? and 2) Is treatment effective in improving cardiac function and clinical outcomes?
This will be an open-label, non-randomized multi-center study of ASC implantation using a
      catheter delivery system. ASCs will be derived from the patient's adipose-derived tissue.
      Liposuction will be performed to collect the adipose tissue specimen for subsequent
      processing to isolate the stem cells. The injection catheter will be used for delivery of the
      ASCs therapy.

      The adipose tissue specimen will be collected mainly from the patient's abdomen using a
      liposuction cannula. The adipose tissue may be collected from other areas if necessary The
      adipose tissue is transferred to the laboratory for separation of the adipose tissue-derived
      stem cells, which are then transferred to an injection/infusion catheter for delivery into
      the akinetic myocardial scar in the region of a previous infarct
allocation: Non-Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Improved cardiac function
time frame: 3 and 6 months after intervention
description: Improvement is observed in cardiac function as assessed by echocardiographic LV function (EF)
measure: Adverse Event
time frame: Duration of study
description: The safety of adipose-derived stem cell injection will be evaluated by assessment of the frequency and nature of adverse events occurring during the study injection and up to the 6-month period following treatment.
intervention type: Procedure
intervention name: Liposuction and stem cell implantation
description: The adipose tissue specimen will be collected mainly from the patient's abdomen using a liposuction cannula. The adipose tissue may be collected from other areas if necessary The adipose tissue is transferred to the laboratory for separation of the adipose tissue-derived stem cells, which are then transferred to an injection/infusion catheter for delivery into the akinetic myocardial scar in the region of a previous infarct
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Sharon McQuillan, MD
role: Principal Investigator
affiliation: Ageless Regenerative Institute
facility: 
country: United States
responsible party type: Sponsor
mesh term: Myocardial Infarction
mesh term: Infarction