<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/NCT01663376</url>
  </required_header>
  <id_info>
    <org_study_id>KSC-MSCs-CLI</org_study_id>
    <nct_id>NCT01663376</nct_id>
  </id_info>
  <brief_title>Safety and Effect of Adipose Tissue Derived Mesenchymal Stem Cells Implantation in Patients With Critical Limb Ischemia</brief_title>
  <official_title>Effects of Adipose Tissue Derived Stem Cells Implantation in Patients With Critical Limb Ischemia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>R-Bio</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Pusan National University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>R-Bio</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to investigate the efficacy and safety of autologous&#xD;
      transplantation of Adipose Tissue derived Mesenchymal stem cells (MSCs) in patient with&#xD;
      critical limb ischemia&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>January 2009</start_date>
  <completion_date type="Actual">April 2011</completion_date>
  <primary_completion_date type="Actual">March 2010</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>Major Adverse Events Analysis (MAEs)</measure>
    <time_frame>48 weeks</time_frame>
    <description>To evaluate the change of treated critical limb ischemia before cell implantation and at 3, 6, 12 months post injection of MSCs</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Ankle-Brachial Index (ABI)</measure>
    <time_frame>48 weeks</time_frame>
    <description>To evaluate the change of treated critical limb ischemia before cell implantation and at 3, 6, 12 months post injection of MSCs.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Digital subtraction angiography (DSA)</measure>
    <time_frame>48 weeks</time_frame>
    <description>To evaluate the change of treated critical limb ischemia before cell implantation and at 3, 6, 12 months post injection of MSCs.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Thermography</measure>
    <time_frame>48 weeks</time_frame>
    <description>To evaluate the change of treated critical limb ischemia before cell implantation and at 3, 6, 12 months post injection of MSCs.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Wong-Baker FACES Pain Rating Score</measure>
    <time_frame>48 weeks</time_frame>
    <description>To evaluate the change of treated critical limb ischemia before cell implantation and at 3, 6, 12 months post injection of MSCs.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Treadmill test</measure>
    <time_frame>48 weeks</time_frame>
    <description>To evaluate the change of treated critical limb ischemia before cell implantation and at 3, 6, 12 months post injection of MSCs.</description>
  </secondary_outcome>
  <enrollment type="Actual">20</enrollment>
  <condition>Critical Limb Ischemia</condition>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Autologous Adipose Tissue derived MSCs Transplantation</intervention_name>
    <description>Intramuscular injection of Autologous Adipose Derived Mesenchymal Stem Cells. Dose : 1x10e8 ~3x10e8 cells</description>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  At least 6 months since the onset CLI(Chronic ASO or Buerger disease)&#xD;
&#xD;
          -  Patients with luminal stenosis &gt; 50% by leg angiography&#xD;
&#xD;
          -  Age is between 20 and 80&#xD;
&#xD;
          -  Patients whose Rutherford's class is II-4, III-5 or III-6 (Patients with rest pain or&#xD;
             ischemic ulcer/necrosis)&#xD;
&#xD;
          -  Patients for whom angioplasty and bypass surgery are not indicated because of&#xD;
             anatomical or procedural reasons or frequent reocclusion/restenosis following&#xD;
             traditional revascularization&#xD;
&#xD;
          -  Patients who can give informed consent themselves in writing&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previous or current history of neoplasm or comorbidity that could impact the patient's&#xD;
             survival&#xD;
&#xD;
          -  Detection of proximal source of emboli including atrial fibrillation&#xD;
&#xD;
          -  Primary hematologic disease, including hypercoagulable states&#xD;
&#xD;
          -  Detection of proliferative retinopathy&#xD;
&#xD;
          -  Entrapment syndrome&#xD;
&#xD;
          -  Alcohol abuse, cocaine amphetamine etc.&#xD;
&#xD;
          -  Detection of osteomyelitis&#xD;
&#xD;
          -  Uncontrolled DM&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Han Cheol Lee, M.D. &amp; Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Pusan National University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Pusan National University Hospital</name>
      <address>
        <city>Pusan</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <results_reference>
    <citation>Lee HC, An SG, Lee HW, Park JS, Cha KS, Hong TJ, Park JH, Lee SY, Kim SP, Kim YD, Chung SW, Bae YC, Shin YB, Kim JI, Jung JS. Safety and effect of adipose tissue-derived stem cell implantation in patients with critical limb ischemia: a pilot study. Circ J. 2012;76(7):1750-60. doi: 10.1253/circj.cj-11-1135. Epub 2012 Apr 12.</citation>
    <PMID>22498564</PMID>
  </results_reference>
  <verification_date>June 2019</verification_date>
  <study_first_submitted>August 8, 2012</study_first_submitted>
  <study_first_submitted_qc>August 10, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 13, 2012</study_first_posted>
  <last_update_submitted>June 3, 2019</last_update_submitted>
  <last_update_submitted_qc>June 3, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">June 5, 2019</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>Chronic Limb-Threatening Ischemia</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/NCT01663376
org study id: KSC-MSCs-CLI
nct id: NCT01663376
lead sponsor: 
collaborator: 
has dmc: No
The purpose of this study is to investigate the efficacy and safety of autologous
      transplantation of Adipose Tissue derived Mesenchymal stem cells (MSCs) in patient with
      critical limb ischemia
allocation: Non-Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Major Adverse Events Analysis (MAEs)
time frame: 48 weeks
description: To evaluate the change of treated critical limb ischemia before cell implantation and at 3, 6, 12 months post injection of MSCs
measure: Ankle-Brachial Index (ABI)
time frame: 48 weeks
description: To evaluate the change of treated critical limb ischemia before cell implantation and at 3, 6, 12 months post injection of MSCs.
measure: Digital subtraction angiography (DSA)
time frame: 48 weeks
description: To evaluate the change of treated critical limb ischemia before cell implantation and at 3, 6, 12 months post injection of MSCs.
measure: Thermography
time frame: 48 weeks
description: To evaluate the change of treated critical limb ischemia before cell implantation and at 3, 6, 12 months post injection of MSCs.
measure: Wong-Baker FACES Pain Rating Score
time frame: 48 weeks
description: To evaluate the change of treated critical limb ischemia before cell implantation and at 3, 6, 12 months post injection of MSCs.
measure: Treadmill test
time frame: 48 weeks
description: To evaluate the change of treated critical limb ischemia before cell implantation and at 3, 6, 12 months post injection of MSCs.
intervention type: Procedure
intervention name: Autologous Adipose Tissue derived MSCs Transplantation
description: Intramuscular injection of Autologous Adipose Derived Mesenchymal Stem Cells. Dose : 1x10e8 ~3x10e8 cells
criteria: 
gender: All
minimum age: 20 Years
maximum age: 80 Years
healthy volunteers: No
last name: Han Cheol Lee, M.D. & Ph.D.
role: Principal Investigator
affiliation: Pusan National University Hospital
facility: 
country: Korea, Republic of
citation: Lee HC, An SG, Lee HW, Park JS, Cha KS, Hong TJ, Park JH, Lee SY, Kim SP, Kim YD, Chung SW, Bae YC, Shin YB, Kim JI, Jung JS. Safety and effect of adipose tissue-derived stem cell implantation in patients with critical limb ischemia: a pilot study. Circ J. 2012;76(7):1750-60. doi: 10.1253/circj.cj-11-1135. Epub 2012 Apr 12.
PMID: 22498564
responsible party type: Sponsor
mesh term: Chronic Limb-Threatening Ischemia
mesh term: Ischemia