<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/NCT04427930</url>
  </required_header>
  <id_info>
    <org_study_id>BSR-CTph3-JS1_FU</org_study_id>
    <nct_id>NCT04427930</nct_id>
  </id_info>
  <brief_title>Follow-up Study for Participants of Jointstem Phase 3 Clinical Trial</brief_title>
  <official_title>Long-Term Safety and Efficacy Extension Study Of Autologous Adipose-Derived Mesenchymal Stem Cells 『JOINTSTEM』 in Patients With Knee Osteoarthiritis: A Phase III Extension Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>R-Bio</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>R-Bio</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this follow-up study is to investigate the efficacy and safety of autologous&#xD;
      Adipose Tissue derived Mesenchymal stem cells (JOINTSTEM®) in patient with severe Knee&#xD;
      Osteoarthritis.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">April 13, 2020</start_date>
  <completion_date type="Anticipated">December 30, 2027</completion_date>
  <primary_completion_date type="Anticipated">December 23, 2026</primary_completion_date>
  <phase>Phase 3</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>Adverse Events</measure>
    <time_frame>5 Years</time_frame>
    <description>Incidence of adverse events from baseline to 5 Years</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change of Western Ontario and McMaster Universities Osteoarthritis Index(WOMAC) scores from baseline</measure>
    <time_frame>5 Years</time_frame>
    <description>Pain, stiffness, and physical function of the knee will be measured by the WOMAC score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>WOMAC 3 subscale score</measure>
    <time_frame>5 Years</time_frame>
    <description>Pain, stiffness, and physical function of the knee will be measured by the Western Ontario and McMaster Universities (WOMAC)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>SF-36</measure>
    <time_frame>5 Years</time_frame>
    <description>The SF(Short Form)-36 Health Survey is a 36-item, patient-reported survey of patient health.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Measuring of Kellgren-Lawrence grade</measure>
    <time_frame>1, 2, 3, 4, 5 Years</time_frame>
    <description>Measuring of Kellgren-Lawrence grade through X-ray</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Measuring of Femoro-tibial anatomical angle(FTA)</measure>
    <time_frame>1, 2, 3, 4, 5 Years</time_frame>
    <description>Measuring of FTA through X-ray</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Measuring of Hip-Knee-Ankle angle(HKA)</measure>
    <time_frame>1, 2, 3, 4, 5 Years</time_frame>
    <description>Measureing of HKA through X-ray</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Measuring of Joint Space Width</measure>
    <time_frame>1, 2, 3, 4, 5 Years</time_frame>
    <description>measuring Joint Space Width through X-ray</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>MRI scan</measure>
    <time_frame>1, 2, 3, 4, 5 Years</time_frame>
    <description>The cartilage defect area is measured using MRI</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">129</enrollment>
  <condition>Knee Osteoarthritis</condition>
  <arm_group>
    <arm_group_label>JOINTSTEM</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Long Term Follow-up after Jointstem Transplantation</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>JOINTSTEM</intervention_name>
    <description>Autologous Adipose Tissue derived MSCs</description>
    <arm_group_label>JOINTSTEM</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participants of Jointstem Phase 3 Clinical Trial&#xD;
&#xD;
          -  Participates who signed informed consent document of this study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  No applicable&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>KANGIL KIM</last_name>
    <role>Principal Investigator</role>
    <affiliation>KyungHee University Gangdong Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>WOOSUK LEE</last_name>
    <role>Principal Investigator</role>
    <affiliation>Gangnam Severance Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>KICHEOR BAE</last_name>
    <role>Principal Investigator</role>
    <affiliation>Keimyung University Dongsan Medical Center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>YONG IN</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Catholic University of Korea</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Keimyung University Dongsan Medical Center</name>
      <address>
        <city>Daegu</city>
        <zip>42601</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>KyungHee University Gangdong Hospital</name>
      <address>
        <city>Seoul</city>
        <zip>05278</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gangnam Severance Hospital</name>
      <address>
        <city>Seoul</city>
        <zip>06273</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Catholic University of Korea, 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>July 2023</verification_date>
  <study_first_submitted>May 20, 2020</study_first_submitted>
  <study_first_submitted_qc>June 9, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 11, 2020</study_first_posted>
  <last_update_submitted>July 7, 2023</last_update_submitted>
  <last_update_submitted_qc>July 7, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 10, 2023</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>
    <mesh_term>Osteoarthritis, Knee</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/NCT04427930
org study id: BSR-CTph3-JS1_FU
nct id: NCT04427930
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The purpose of this follow-up study is to investigate the efficacy and safety of autologous
      Adipose Tissue derived Mesenchymal stem cells (JOINTSTEM®) in patient with severe Knee
      Osteoarthritis.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Adverse Events
time frame: 5 Years
description: Incidence of adverse events from baseline to 5 Years
measure: Change of Western Ontario and McMaster Universities Osteoarthritis Index(WOMAC) scores from baseline
time frame: 5 Years
description: Pain, stiffness, and physical function of the knee will be measured by the WOMAC score
measure: WOMAC 3 subscale score
time frame: 5 Years
description: Pain, stiffness, and physical function of the knee will be measured by the Western Ontario and McMaster Universities (WOMAC)
measure: SF-36
time frame: 5 Years
description: The SF(Short Form)-36 Health Survey is a 36-item, patient-reported survey of patient health.
measure: Measuring of Kellgren-Lawrence grade
time frame: 1, 2, 3, 4, 5 Years
description: Measuring of Kellgren-Lawrence grade through X-ray
measure: Measuring of Femoro-tibial anatomical angle(FTA)
time frame: 1, 2, 3, 4, 5 Years
description: Measuring of FTA through X-ray
measure: Measuring of Hip-Knee-Ankle angle(HKA)
time frame: 1, 2, 3, 4, 5 Years
description: Measureing of HKA through X-ray
measure: Measuring of Joint Space Width
time frame: 1, 2, 3, 4, 5 Years
description: measuring Joint Space Width through X-ray
measure: MRI scan
time frame: 1, 2, 3, 4, 5 Years
description: The cartilage defect area is measured using MRI
arm group label: JOINTSTEM
arm group type: Experimental
description: Long Term Follow-up after Jointstem Transplantation
intervention type: Biological
intervention name: JOINTSTEM
description: Autologous Adipose Tissue derived MSCs
arm group label: JOINTSTEM
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
last name: KANGIL KIM
role: Principal Investigator
affiliation: KyungHee University Gangdong Hospital
last name: WOOSUK LEE
role: Principal Investigator
affiliation: Gangnam Severance Hospital
last name: KICHEOR BAE
role: Principal Investigator
affiliation: Keimyung University Dongsan Medical Center
last name: YONG IN
role: Principal Investigator
affiliation: The Catholic University of Korea
facility: 
facility: 
facility: 
facility: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Osteoarthritis
mesh term: Osteoarthritis, Knee