<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/NCT02975960</url>
  </required_header>
  <id_info>
    <org_study_id>KC16TISI0343</org_study_id>
    <nct_id>NCT02975960</nct_id>
  </id_info>
  <brief_title>ADMSCs for the Treatment of Systemic Sclerosis</brief_title>
  <official_title>Adipose Tissue-derived Mesenchymal Stem Cells for Cell-based Therapy in the Treatment of Systemic Sclerosis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The Catholic University of Korea</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Seoul St. Mary's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>The Catholic University of Korea</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Systemic sclerosis (SSc) is a rare autoimmune disease, mainly characterized by cutaneous and&#xD;
      visceral fibrosis. Digital ulcer and sclerosing skin are commonly affected on hands, but the&#xD;
      treatment for these manifestations are often ineffective.&#xD;
&#xD;
      Adipose tissue contains stromal vascular fraction (SVF), which is abundant multipotent stem&#xD;
      cells, capable of tissue repair. A prior study (NCT01813279) has shown the safety and&#xD;
      tolerance at 6 months of the subcutaneous injection of SVF in the fingers in SSc.&#xD;
&#xD;
      There are only few ways to manage SSc patients with skin lesion who already have treated with&#xD;
      several medications (including vasodilators, PDE5 inhibitor, endothelin receptor antagonist)&#xD;
      but some times their skin lesions are critical physically and emotionally.&#xD;
&#xD;
      Autologous SVF injection could be one of the treatment options to treat skin lesion of SSc.&#xD;
      Thus, the investigators study the efficacy and potential adverse event in Korean patients&#xD;
      with SSc.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In this study, the investigators will inject autologous Stromal vascular fraction.&#xD;
&#xD;
      1) Acquiring autologous stromal vascular fraction by plastic surgeon&#xD;
&#xD;
        1. Liposuction&#xD;
&#xD;
        2. Extraction and purifying SVF using Smart-X system (15-20 min)&#xD;
&#xD;
        3. Making syringe filled with autologous SVF&#xD;
&#xD;
      2) SVF injection&#xD;
&#xD;
      Inject SVF subcutaneously with 25G needle in finger&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 25, 2016</start_date>
  <completion_date type="Actual">January 20, 2018</completion_date>
  <primary_completion_date type="Actual">October 30, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from baseline modified Rodnan Skin score (mRSS) of hands at 12 weeks</measure>
    <time_frame>baseline, 12 weeks</time_frame>
    <description>Assess hands mRSS</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from baseline Raynaud's condition score at 12 weeks</measure>
    <time_frame>baseline, 12 weeks</time_frame>
    <description>The severity (frequency and intensity of crises) of Raynaud's phenomenon</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline Visual Analog Score for pain the hands at 12 weeks</measure>
    <time_frame>baseline, 12 weeks</time_frame>
    <description>Patient report hand pain degree, comparing baseline and 12 weeks</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes from baseline mRSS (total) at 12 weeks</measure>
    <time_frame>baseline, 12 weeks</time_frame>
    <description>Assess total mRSS (including hands)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline Kapandji score at 12weeks</measure>
    <time_frame>baseline, 12 weeks</time_frame>
    <description>assess the mobility of both hands</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline Cochin hand function scale at 12 weeks</measure>
    <time_frame>baseline, 12 weeks</time_frame>
    <description>Assess hand function (patients reported outcome)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline Systemic sclerosis HAQ at 12 weeks</measure>
    <time_frame>baseline, 12 weeks</time_frame>
    <description>he quality of life- score adapted to systemic sclerosis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline peripheral vasculature at 12 weeks</measure>
    <time_frame>baseline, 12 weeks</time_frame>
    <description>Assess peripheral vascularity by Nailfold capillaroscopy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline finger circumference at 12 weeks</measure>
    <time_frame>baseline, 12 weeks</time_frame>
    <description>Measure second to fifth finger circumference</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">7</enrollment>
  <condition>Systemic Sclerosis</condition>
  <arm_group>
    <arm_group_label>Stromal vascular fraction injection</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Injection of autologous stromal vascular fraction on hand.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>injection of autologous stromal vascular fraction</intervention_name>
    <description>Acquiring autologous stromal vascular fraction (SVF) from liposuction&#xD;
purifying SVF from lipoaspirates and making syringe filled with SVF&#xD;
SVF injection - Inject SVF on fingers subcutaneously.</description>
    <arm_group_label>Stromal vascular fraction injection</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients who fulfill 2013 American college of Rheumatology/ European League Against&#xD;
             Rheumatism Criteria for the classification of systemic sclerosis.&#xD;
&#xD;
          2. The skin lesion was not improved after 6 months treatment with conventional therapy.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Pregnancy&#xD;
&#xD;
          2. Start new medications within 3 months prior to enrollment&#xD;
&#xD;
          3. Previous sympathectomy or amputation&#xD;
&#xD;
          4. Current systemic infection&#xD;
&#xD;
          5. AIDS, Syphilis, hepatitis B&amp;C&#xD;
&#xD;
          6. BMI &lt;17kg/m2&#xD;
&#xD;
          7. Cognitive dysfunction and other psychologic problems&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jung Hee Koh, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Seoul St.Mary's hospital, The Catholic university of Korea</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Seoul St. Mary's hospital</name>
      <address>
        <city>Seoul</city>
        <zip>06591</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>January 2018</verification_date>
  <study_first_submitted>November 9, 2016</study_first_submitted>
  <study_first_submitted_qc>November 23, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 29, 2016</study_first_posted>
  <last_update_submitted>January 23, 2018</last_update_submitted>
  <last_update_submitted_qc>January 23, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">January 25, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The Catholic University of Korea</investigator_affiliation>
    <investigator_full_name>Jung Hee Koh</investigator_full_name>
    <investigator_title>Clinical Professor, Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>systemic sclerosis</keyword>
  <keyword>adipose derived stem cell</keyword>
  <keyword>stromal vascular fraction</keyword>
  <keyword>digital ulcer</keyword>
  <keyword>gangrene</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Scleroderma, Systemic</mesh_term>
    <mesh_term>Scleroderma, Diffuse</mesh_term>
    <mesh_term>Sclerosis</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/NCT02975960
org study id: KC16TISI0343
nct id: NCT02975960
lead sponsor: 
collaborator: 
has dmc: Yes
Systemic sclerosis (SSc) is a rare autoimmune disease, mainly characterized by cutaneous and
      visceral fibrosis. Digital ulcer and sclerosing skin are commonly affected on hands, but the
      treatment for these manifestations are often ineffective.

      Adipose tissue contains stromal vascular fraction (SVF), which is abundant multipotent stem
      cells, capable of tissue repair. A prior study (NCT01813279) has shown the safety and
      tolerance at 6 months of the subcutaneous injection of SVF in the fingers in SSc.

      There are only few ways to manage SSc patients with skin lesion who already have treated with
      several medications (including vasodilators, PDE5 inhibitor, endothelin receptor antagonist)
      but some times their skin lesions are critical physically and emotionally.

      Autologous SVF injection could be one of the treatment options to treat skin lesion of SSc.
      Thus, the investigators study the efficacy and potential adverse event in Korean patients
      with SSc.
In this study, the investigators will inject autologous Stromal vascular fraction.

      1) Acquiring autologous stromal vascular fraction by plastic surgeon

        1. Liposuction

        2. Extraction and purifying SVF using Smart-X system (15-20 min)

        3. Making syringe filled with autologous SVF

      2) SVF injection

      Inject SVF subcutaneously with 25G needle in finger
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change from baseline modified Rodnan Skin score (mRSS) of hands at 12 weeks
time frame: baseline, 12 weeks
description: Assess hands mRSS
measure: Change from baseline Raynaud's condition score at 12 weeks
time frame: baseline, 12 weeks
description: The severity (frequency and intensity of crises) of Raynaud's phenomenon
measure: Change from baseline Visual Analog Score for pain the hands at 12 weeks
time frame: baseline, 12 weeks
description: Patient report hand pain degree, comparing baseline and 12 weeks
measure: Changes from baseline mRSS (total) at 12 weeks
time frame: baseline, 12 weeks
description: Assess total mRSS (including hands)
measure: Change from baseline Kapandji score at 12weeks
time frame: baseline, 12 weeks
description: assess the mobility of both hands
measure: Change from baseline Cochin hand function scale at 12 weeks
time frame: baseline, 12 weeks
description: Assess hand function (patients reported outcome)
measure: Change from baseline Systemic sclerosis HAQ at 12 weeks
time frame: baseline, 12 weeks
description: he quality of life- score adapted to systemic sclerosis
measure: Change from baseline peripheral vasculature at 12 weeks
time frame: baseline, 12 weeks
description: Assess peripheral vascularity by Nailfold capillaroscopy
measure: Change from baseline finger circumference at 12 weeks
time frame: baseline, 12 weeks
description: Measure second to fifth finger circumference
arm group label: Stromal vascular fraction injection
arm group type: Experimental
description: Injection of autologous stromal vascular fraction on hand.
intervention type: Biological
intervention name: injection of autologous stromal vascular fraction
description: Acquiring autologous stromal vascular fraction (SVF) from liposuction
purifying SVF from lipoaspirates and making syringe filled with SVF
SVF injection - Inject SVF on fingers subcutaneously.
arm group label: Stromal vascular fraction injection
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jung Hee Koh, MD
role: Principal Investigator
affiliation: Seoul St.Mary's hospital, The Catholic university of Korea
facility: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: The Catholic University of Korea
investigator full name: Jung Hee Koh
investigator title: Clinical Professor, Principal Investigator
mesh term: Scleroderma, Systemic
mesh term: Scleroderma, Diffuse
mesh term: Sclerosis
sharing ipd: No