<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/NCT02241408</url>
  </required_header>
  <id_info>
    <org_study_id>SVF01OA</org_study_id>
    <secondary_id>ASCOA-01</secondary_id>
    <nct_id>NCT02241408</nct_id>
  </id_info>
  <brief_title>Outcomes Data of Adipose Stem Cells to Treat Osteoarthritis</brief_title>
  <official_title>Autologous Adipose Stromal Vascular Fraction Outcomes in Osteoarthritis Research Study</official_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 joint pain and functionality in people with Osteoarthritis (OA). SVF contains&#xD;
      components with &quot;regenerative&quot; properties, including stem cells that have shown promise for&#xD;
      ameliorating specific disease conditions. This study is designed to evaluate joint pain and&#xD;
      functionality changes in individuals with OA for up to 12 months following SVF treatment.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>September 2014</start_date>
  <completion_date type="Anticipated">September 2019</completion_date>
  <primary_completion_date type="Anticipated">September 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 Knee Assessment Over the Course of a 12 Month Period as Measured by the Knee Injury and Osteoarthritis Outcome Score (KOOS LK 1.0)</measure>
    <time_frame>Baseline, 12 months</time_frame>
    <description>The change from baseline over the course of 12 months using participants' assessment of their knee and associated problems. 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 on a 5 point Likert scale and each question gets a score from 0 to 4.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from Baseline in Overall Hip Assessment Over the Course of a 12 Month Period as Measured by the Hip Dysfunction and Osteoarthritis Outcome Score (HOOS LK 2.0)</measure>
    <time_frame>Baseline, 12 months</time_frame>
    <description>The change from baseline over the course of 12 months using participants' assessment of their hip and associated problems. 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 on a 5 point Likert scale and each question gets a score from 0 to 4.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline in Knee Pain at Month 12 as Measured by Participants Using the Knee Injury and Osteoarthritis Outcome Score (KOOS LK 1.0) The Pain Subscale</measure>
    <time_frame>Baseline, Month 12</time_frame>
    <description>Participant assessment in the change in knee pain from baseline to month 12 using the KOOS pain subscale.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline in Function in Daily Living (ADL) at Month 12 as Measured by Participants Using the Knee Injury and Osteoarthritis Outcome Score (KOOS LK 1.0) The ADL Subscale</measure>
    <time_frame>Baseline, Month 12</time_frame>
    <description>Participant assessment in the change in function in daily living from baseline to month 12 using the KOOS ADL subscale.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline in Function in Sport and Recreation at Month 12 as Measured by Participants Using the Knee Injury and Osteoarthritis Outcome Score (KOOS LK 1.0) The Sport/Rec Subscale</measure>
    <time_frame>Baseline, Month 12</time_frame>
    <description>Participant assessment in the change in sport and recreation from baseline to month 12 using the KOOS sport/rec subscale.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline in Knee Related Quality of Life (QOL) at Month 12 as Measured by Participants Using the Knee Injury and Osteoarthritis Outcome Score (KOOS LK 1.0) The Knee Related Quality of Life Subscale</measure>
    <time_frame>Baseline, Month 12</time_frame>
    <description>Participant assessment in the change in knee related quality of life from baseline to month 12 using the KOOS QOL subscale.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline in Other Knee Symptoms at Month 12 as Measured by Participants Using the Knee Injury and Osteoarthritis Outcome Score (KOOS LK 1.0) The Other Symptoms Subscale</measure>
    <time_frame>Baseline, Month 12</time_frame>
    <description>Participant assessment in the change in other knee symptoms from baseline to month 12 using the KOOS other symptoms subscale.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline in Hip Pain at Month 12 as Measured by Participants Using the Hip Dysfunction and Osteoarthritis Outcome Score (HOOS LK 2.0) The Pain Subscale</measure>
    <time_frame>Baseline, Month 12</time_frame>
    <description>Participant assessment in the change in hip pain from baseline to month 12 using the HOOS pain subscale.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline in Function in Daily Living (ADL) at Month 12 as Measured by Participants Using the Hip Dysfunction and Osteoarthritis Outcome Score (HOOS LK 2.0) The ADL Subscale</measure>
    <time_frame>Baseline, Month 12</time_frame>
    <description>Participant assessment in the change in function in daily living from baseline to month 12 using the HOOS ADL subscale.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline in Function in Sport and Recreation at Month 12 as Measured by Participants Using the Hip Dysfunction and Osteoarthritis Outcome Score (HOOS LK 2.0) The Sport/Rec Subscale</measure>
    <time_frame>Baseline, Month 12</time_frame>
    <description>Participant assessment in the change in function in sport and recreation from baseline to month 12 using the HOOS sport/rec subscale.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline in Hip Related Quality of Life (QOL) at Month 12 as Measured by Participants Using the Hip Dysfunction and Osteoarthritis Outcome Score (HOOS LK 2.0) The QOL Subscale</measure>
    <time_frame>Baseline, Month 12</time_frame>
    <description>Participant assessment in the change in hip related quality of life from baseline to month 12 using the HOOS QOL subscale.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline in Other Hip Symptoms at Month 12 as Measured by Participants Using the Hip Dysfunction and Osteoarthritis Outcome Score (HOOS LK 2.0) The Other Symptoms Subscale</measure>
    <time_frame>Baseline, Month 12</time_frame>
    <description>Participant assessment in the change in other hip symptoms from baseline to month 12 using the HOOS other symptoms subscale.</description>
  </secondary_outcome>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Osteoarthritis</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Community Sample&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Fluent in English&#xD;
&#xD;
          -  Over the age of 18&#xD;
&#xD;
          -  Diagnosed with OA of the knee and/or hip&#xD;
&#xD;
          -  Scheduled for intravenous and intra-articular administrations of autologous SVF&#xD;
&#xD;
          -  Capable of understanding and willing to sign informed consent&#xD;
&#xD;
          -  Willing and able to complete brief phone interviews&#xD;
&#xD;
          -  Willing and able to complete online surveys&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Co-morbidity with an autoimmune disorder&#xD;
&#xD;
          -  Pregnant, may become pregnant, or breastfeeding&#xD;
&#xD;
          -  Subjects for which baseline data is not available&#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_contact>
    <last_name>Holly Bergen</last_name>
    <phone>800-609-7795</phone>
  </overall_contact>
  <location>
    <facility>
      <name>StemGenex</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92121</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <phone>855-742-7836</phone>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2018</verification_date>
  <study_first_submitted>September 13, 2014</study_first_submitted>
  <study_first_submitted_qc>September 13, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 16, 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>Osteoarthritis</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/NCT02241408
org study id: SVF01OA
secondary id: ASCOA-01
nct id: NCT02241408
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 joint pain and functionality in people with Osteoarthritis (OA). SVF contains
      components with "regenerative" properties, including stem cells that have shown promise for
      ameliorating specific disease conditions. This study is designed to evaluate joint pain and
      functionality changes in individuals with OA for up to 12 months following SVF treatment.
observational model: Cohort
time perspective: Prospective
measure: Change from Baseline in Overall Knee Assessment Over the Course of a 12 Month Period as Measured by the Knee Injury and Osteoarthritis Outcome Score (KOOS LK 1.0)
time frame: Baseline, 12 months
description: The change from baseline over the course of 12 months using participants' assessment of their knee and associated problems. 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 on a 5 point Likert scale and each question gets a score from 0 to 4.
measure: Change from Baseline in Overall Hip Assessment Over the Course of a 12 Month Period as Measured by the Hip Dysfunction and Osteoarthritis Outcome Score (HOOS LK 2.0)
time frame: Baseline, 12 months
description: The change from baseline over the course of 12 months using participants' assessment of their hip and associated problems. 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 on a 5 point Likert scale and each question gets a score from 0 to 4.
measure: Change from Baseline in Knee Pain at Month 12 as Measured by Participants Using the Knee Injury and Osteoarthritis Outcome Score (KOOS LK 1.0) The Pain Subscale
time frame: Baseline, Month 12
description: Participant assessment in the change in knee pain from baseline to month 12 using the KOOS pain subscale.
measure: Change from Baseline in Function in Daily Living (ADL) at Month 12 as Measured by Participants Using the Knee Injury and Osteoarthritis Outcome Score (KOOS LK 1.0) The ADL Subscale
time frame: Baseline, Month 12
description: Participant assessment in the change in function in daily living from baseline to month 12 using the KOOS ADL subscale.
measure: Change from Baseline in Function in Sport and Recreation at Month 12 as Measured by Participants Using the Knee Injury and Osteoarthritis Outcome Score (KOOS LK 1.0) The Sport/Rec Subscale
time frame: Baseline, Month 12
description: Participant assessment in the change in sport and recreation from baseline to month 12 using the KOOS sport/rec subscale.
measure: Change from Baseline in Knee Related Quality of Life (QOL) at Month 12 as Measured by Participants Using the Knee Injury and Osteoarthritis Outcome Score (KOOS LK 1.0) The Knee Related Quality of Life Subscale
time frame: Baseline, Month 12
description: Participant assessment in the change in knee related quality of life from baseline to month 12 using the KOOS QOL subscale.
measure: Change from Baseline in Other Knee Symptoms at Month 12 as Measured by Participants Using the Knee Injury and Osteoarthritis Outcome Score (KOOS LK 1.0) The Other Symptoms Subscale
time frame: Baseline, Month 12
description: Participant assessment in the change in other knee symptoms from baseline to month 12 using the KOOS other symptoms subscale.
measure: Change from Baseline in Hip Pain at Month 12 as Measured by Participants Using the Hip Dysfunction and Osteoarthritis Outcome Score (HOOS LK 2.0) The Pain Subscale
time frame: Baseline, Month 12
description: Participant assessment in the change in hip pain from baseline to month 12 using the HOOS pain subscale.
measure: Change from Baseline in Function in Daily Living (ADL) at Month 12 as Measured by Participants Using the Hip Dysfunction and Osteoarthritis Outcome Score (HOOS LK 2.0) The ADL Subscale
time frame: Baseline, Month 12
description: Participant assessment in the change in function in daily living from baseline to month 12 using the HOOS ADL subscale.
measure: Change from Baseline in Function in Sport and Recreation at Month 12 as Measured by Participants Using the Hip Dysfunction and Osteoarthritis Outcome Score (HOOS LK 2.0) The Sport/Rec Subscale
time frame: Baseline, Month 12
description: Participant assessment in the change in function in sport and recreation from baseline to month 12 using the HOOS sport/rec subscale.
measure: Change from Baseline in Hip Related Quality of Life (QOL) at Month 12 as Measured by Participants Using the Hip Dysfunction and Osteoarthritis Outcome Score (HOOS LK 2.0) The QOL Subscale
time frame: Baseline, Month 12
description: Participant assessment in the change in hip related quality of life from baseline to month 12 using the HOOS QOL subscale.
measure: Change from Baseline in Other Hip Symptoms at Month 12 as Measured by Participants Using the Hip Dysfunction and Osteoarthritis Outcome Score (HOOS LK 2.0) The Other Symptoms Subscale
time frame: Baseline, Month 12
description: Participant assessment in the change in other hip symptoms from baseline to month 12 using the HOOS other symptoms subscale.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Holly Bergen
phone: 800-609-7795
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Sponsor
mesh term: Osteoarthritis