<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/NCT02184546</url>
  </required_header>
  <id_info>
    <org_study_id>SVF01PD</org_study_id>
    <secondary_id>ASCPD-01</secondary_id>
    <nct_id>NCT02184546</nct_id>
  </id_info>
  <brief_title>Outcomes Data of Adipose Stem Cells to Treat Parkinson's Disease</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>StemGenex</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>StemGenex</source>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine the impact that treatment with a cellular&#xD;
      concentrate derived from an individual's own fat, known as the stromal vascular fraction&#xD;
      (SVF), has on the quality of life of people with Parkinson's disease (PD). SVF contains&#xD;
      components with &quot;regenerative&quot; properties, including stem cells that may be capable of&#xD;
      ameliorating specific disease conditions. This study is designed to evaluate quality of life&#xD;
      changes in individuals with PD for up to 12 months following SVF treatment.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>July 2014</start_date>
  <completion_date type="Anticipated">July 2019</completion_date>
  <primary_completion_date type="Anticipated">July 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Change from Baseline in Overall Quality of Life Over the Course of a 12 Month Period as Measured by the Parkinson's Disease Quality of Life Questionnaire (PDQUALIF)</measure>
    <time_frame>Baseline, 12 months</time_frame>
    <description>The change from baseline over the course of 12 months using participants' assessment of their overall quality of life. Mean scores will be used for baseline (day 0) and all interviews up to month 12 (months 1, 3, 6, and 12). Answer options are graded according to one of seven various five-point Likert response scales.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline in Social and Role Function at Month 12 as Measured by Participants Using the Parkinson's Disease Quality of Life Questionnaire (PDQUALIF) The Social and Role Function Subscale</measure>
    <time_frame>Baseline, Month 12</time_frame>
    <description>Participant assessment of the change in their social functioning from baseline to month 12 using the PDQUALIF social and role function subscale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline in Self Image and Sexuality at Month 12 as Measured by Participants Using the Parkinson's Disease Quality of Life Questionnaire (PDQUALIF) The Self Image and Sexuality Subscale</measure>
    <time_frame>Baseline, Month 12</time_frame>
    <description>Participant assessment of the change in their self image and sexual functioning from baseline to month 12 using the PDQUALIF self image and sexuality subscale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline in Sleep at Month 12 as Measured by Participants Using the Parkinson's Disease Quality of Life Questionnaire (PDQUALIF) The Sleep Subscale</measure>
    <time_frame>Baseline, Month 12</time_frame>
    <description>Participant assessment of the change in their sleep quality from baseline to month 12 using the PDQUALIF sleep subscale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline in Outlook at Month 12 as Measured by Participants Using the Parkinson's Disease Quality of Life Questionnaire (PDQUALIF) The Outlook Subscale</measure>
    <time_frame>Baseline, Month 12</time_frame>
    <description>Participant assessment of the change in their life outlook from baseline to month 12 using the PDQUALIF outlook subscale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline in Physical Functioning at Month 12 as Measured by Participants Using the Parkinson's Disease Quality of Life Questionnaire (PDQUALIF) The Physical Functioning Subscale</measure>
    <time_frame>Baseline, Month 12</time_frame>
    <description>Participant assessment of the change in their physical functioning from baseline to month 12 using the PDQUALIF physical functioning subscale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline in Independence at Month 12 as Measured by Participants Using the Parkinson's Disease Quality of Life Questionnaire (PDQUALIF) The Independence Subscale</measure>
    <time_frame>Baseline, Month 12</time_frame>
    <description>Participant assessment of the change in their feeling of independence from baseline to month 12 using the PDQUALIF independence subscale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline in Urinary Function at Month 12 as Measured by Participants Using the Parkinson's Disease Quality of Life Questionnaire (PDQUALIF) The Urinary Function Subscale</measure>
    <time_frame>Baseline, Month 12</time_frame>
    <description>Participant assessment of the change in their urinary function from baseline to month 12 using the PDQUALIF urinary function subscale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline in Global Health-Related Quality of Life at Month 12 as Measured by Participants Using the Parkinson's Disease Quality of Life Questionnaire (PDQUALIF) The Global HRQoL Subscale</measure>
    <time_frame>Baseline, Month 12</time_frame>
    <description>Participant assessment of the change in their overall health-related quality of life from baseline to month 12 using the PDQUALIF global HRQoL subscale</description>
  </secondary_outcome>
  <enrollment type="Actual">75</enrollment>
  <condition>Parkinson's Disease</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Community Sample&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects scheduled for a stem cell/SVF treatment&#xD;
&#xD;
          -  Subjects diagnosed with idiopathic Parkinson's disease&#xD;
&#xD;
          -  Subjects ages 18 years and older&#xD;
&#xD;
          -  Subjects willing and able to sign informed consent&#xD;
&#xD;
          -  Subjects willing and able to perform follow up interviews and surveys&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects with additional major health diagnoses&#xD;
&#xD;
          -  Subjects that are pregnant or breastfeeding&#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>StemGenex</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92121</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2018</verification_date>
  <study_first_submitted>July 3, 2014</study_first_submitted>
  <study_first_submitted_qc>July 3, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 9, 2014</study_first_posted>
  <last_update_submitted>August 28, 2018</last_update_submitted>
  <last_update_submitted_qc>August 28, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">August 31, 2018</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>Parkinson Disease</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/NCT02184546
org study id: SVF01PD
secondary id: ASCPD-01
nct id: NCT02184546
lead sponsor: 
The purpose of this study is to determine the impact that treatment with a cellular
      concentrate derived from an individual's own fat, known as the stromal vascular fraction
      (SVF), has on the quality of life of people with Parkinson's disease (PD). SVF contains
      components with "regenerative" properties, including stem cells that may be capable of
      ameliorating specific disease conditions. This study is designed to evaluate quality of life
      changes in individuals with PD for up to 12 months following SVF treatment.
observational model: Cohort
time perspective: Prospective
measure: Change from Baseline in Overall Quality of Life Over the Course of a 12 Month Period as Measured by the Parkinson's Disease Quality of Life Questionnaire (PDQUALIF)
time frame: Baseline, 12 months
description: The change from baseline over the course of 12 months using participants' assessment of their overall quality of life. Mean scores will be used for baseline (day 0) and all interviews up to month 12 (months 1, 3, 6, and 12). Answer options are graded according to one of seven various five-point Likert response scales.
measure: Change from Baseline in Social and Role Function at Month 12 as Measured by Participants Using the Parkinson's Disease Quality of Life Questionnaire (PDQUALIF) The Social and Role Function Subscale
time frame: Baseline, Month 12
description: Participant assessment of the change in their social functioning from baseline to month 12 using the PDQUALIF social and role function subscale
measure: Change from Baseline in Self Image and Sexuality at Month 12 as Measured by Participants Using the Parkinson's Disease Quality of Life Questionnaire (PDQUALIF) The Self Image and Sexuality Subscale
time frame: Baseline, Month 12
description: Participant assessment of the change in their self image and sexual functioning from baseline to month 12 using the PDQUALIF self image and sexuality subscale
measure: Change from Baseline in Sleep at Month 12 as Measured by Participants Using the Parkinson's Disease Quality of Life Questionnaire (PDQUALIF) The Sleep Subscale
time frame: Baseline, Month 12
description: Participant assessment of the change in their sleep quality from baseline to month 12 using the PDQUALIF sleep subscale
measure: Change from Baseline in Outlook at Month 12 as Measured by Participants Using the Parkinson's Disease Quality of Life Questionnaire (PDQUALIF) The Outlook Subscale
time frame: Baseline, Month 12
description: Participant assessment of the change in their life outlook from baseline to month 12 using the PDQUALIF outlook subscale
measure: Change from Baseline in Physical Functioning at Month 12 as Measured by Participants Using the Parkinson's Disease Quality of Life Questionnaire (PDQUALIF) The Physical Functioning Subscale
time frame: Baseline, Month 12
description: Participant assessment of the change in their physical functioning from baseline to month 12 using the PDQUALIF physical functioning subscale
measure: Change from Baseline in Independence at Month 12 as Measured by Participants Using the Parkinson's Disease Quality of Life Questionnaire (PDQUALIF) The Independence Subscale
time frame: Baseline, Month 12
description: Participant assessment of the change in their feeling of independence from baseline to month 12 using the PDQUALIF independence subscale
measure: Change from Baseline in Urinary Function at Month 12 as Measured by Participants Using the Parkinson's Disease Quality of Life Questionnaire (PDQUALIF) The Urinary Function Subscale
time frame: Baseline, Month 12
description: Participant assessment of the change in their urinary function from baseline to month 12 using the PDQUALIF urinary function subscale
measure: Change from Baseline in Global Health-Related Quality of Life at Month 12 as Measured by Participants Using the Parkinson's Disease Quality of Life Questionnaire (PDQUALIF) The Global HRQoL Subscale
time frame: Baseline, Month 12
description: Participant assessment of the change in their overall health-related quality of life from baseline to month 12 using the PDQUALIF global HRQoL subscale
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United States
responsible party type: Sponsor
mesh term: Parkinson Disease