xml: <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/NCT06013306</url>
    </required_header>
    <id_info>
      <org_study_id>K0701-E</org_study_id>
      <nct_id>NCT06013306</nct_id>
    </id_info>
    <brief_title>Long-Term Follow-up Study of Subjects With Knee Osteoarthritis Who Had Administered FURESTEM-OA Kit Inj. in K0701 Study</brief_title>
    <official_title>Long-Term Follow-up Study of Subjects With Knee Osteoarthritis Who Had Administered FURESTEM-OA Kit Inj. in K0701 Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Kang Stem Biotech Co., Ltd.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Kang Stem Biotech Co., Ltd.</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>
        Long-Term Follow-up Study of Subjects with Knee Osteoarthritis who had administered&#xD;
        FURESTEM-OA Kit Inj. in K0701 study&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 14, 2023</start_date>
    <completion_date type="Anticipated">December 30, 2030</completion_date>
    <primary_completion_date type="Anticipated">November 7, 2029</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Only</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Number of AESI</measure>
      <time_frame>5 years follow-up after treatment</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Number of SS</measure>
      <time_frame>5 years follow-up after treatment</time_frame>
    </primary_outcome>
    <secondary_outcome>
      <measure>Changes in Knee Injury and Osteoarthritis Outcome Score (KOOS)</measure>
      <time_frame>1 year (52 weeks), 2 years (104 weeks), and 3 years (156 weeks) after treatment</time_frame>
      <description>The higher the score, the worse the condition of the disease is.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Changes in Western Ontario and McMaster Universities osteoarthritis index (WOMAC)</measure>
      <time_frame>1 year (52 weeks), 2 years (104 weeks), and 3 years (156 weeks) after treatment</time_frame>
      <description>The WOMAC evaluation is evaluated using the score value converted through the KOOS evaluation paper.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Changes in 100-mm VAS</measure>
      <time_frame>1 year (52 weeks), 2 years (104 weeks), and 3 years (156 weeks) after treatment</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Changes in International Knee Documentation Committee Scoring System (IKDC)</measure>
      <time_frame>1 year (52 weeks), 2 years (104 weeks), and 3 years (156 weeks) after treatment</time_frame>
      <description>A higher score indicates better function and less symptomatic</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Evaluation of International K&amp;L grade(X-ray)</measure>
      <time_frame>1 year (52 weeks), 2 years (104 weeks), and 3 years (156 weeks) after treatment</time_frame>
      <description>Grade 0 - No radioligical findings of osteoarthritis Grade 1 - Doubtful narrowing of joint space and possible osteophytic lipping Grade 2 - Definite osteophytes and possible narrowing of joint space Grade 3 - Moderate osteophytes, definite narrowing of joint space, and some sclerosis and deformity of bone ends Grade 4 - Large osteophytes, marked narrowing of joint space, severe sclerosis, and definite deformity of bone ends</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) scores(MRI)</measure>
      <time_frame>1 year (52 weeks), 2 years (104 weeks), and 3 years (156 weeks) after treatment</time_frame>
      <description>A higher score indicates better function and less symptomatic</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Whole-Organ Magnetic Resonance Imaging Score (WORMS) score</measure>
      <time_frame>1 year (52 weeks), 2 years (104 weeks), and 3 years (156 weeks) after treatment</time_frame>
      <description>The higher the score means normal state.</description>
    </secondary_outcome>
    <enrollment type="Anticipated">58</enrollment>
    <condition>Knee Osteoarthritis</condition>
    <eligibility>
      <study_pop>
        <textblock>
          Those who participated in the K0701 clinical trial and received PureStem-OA Kit Inj&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Those who participated in the K0701 clinical trial and received PureStem-OA Kit Inj&#xD;
  &#xD;
            -  Those who understand and voluntarily sign an informed consent form&#xD;
  &#xD;
          exclusion criteria&#xD;
  &#xD;
            -  None&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>19 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Kyoung-Ho Yoon, professor (CI)</last_name>
      <role>Principal Investigator</role>
      <affiliation>Kyung Hee University Hospital</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Sang Hak Lee, professor</last_name>
      <role>Principal Investigator</role>
      <affiliation>Gangdong Kyunghee University Hospital</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Chaeeun JEON</last_name>
      <phone>02-2036-7614</phone>
      <email>cejeon@kangstem.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Hyeseung JEON</last_name>
      <phone>02-888-1592</phone>
      <email>hsjeon@kangstem.com</email>
    </overall_contact_backup>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 22, 2023</study_first_submitted>
    <study_first_submitted_qc>August 22, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 28, 2023</study_first_posted>
    <last_update_submitted>August 28, 2023</last_update_submitted>
    <last_update_submitted_qc>August 28, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 30, 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>
  
  
text: 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/NCT06013306
  org study id: K0701-E
  nct id: NCT06013306
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  Long-Term Follow-up Study of Subjects with Knee Osteoarthritis who had administered
        FURESTEM-OA Kit Inj. in K0701 study
  observational model: Case-Only
  time perspective: Prospective
  measure: Number of AESI
  time frame: 5 years follow-up after treatment
  measure: Number of SS
  time frame: 5 years follow-up after treatment
  measure: Changes in Knee Injury and Osteoarthritis Outcome Score (KOOS)
  time frame: 1 year (52 weeks), 2 years (104 weeks), and 3 years (156 weeks) after treatment
  description: The higher the score, the worse the condition of the disease is.
  measure: Changes in Western Ontario and McMaster Universities osteoarthritis index (WOMAC)
  time frame: 1 year (52 weeks), 2 years (104 weeks), and 3 years (156 weeks) after treatment
  description: The WOMAC evaluation is evaluated using the score value converted through the KOOS evaluation paper.
  measure: Changes in 100-mm VAS
  time frame: 1 year (52 weeks), 2 years (104 weeks), and 3 years (156 weeks) after treatment
  measure: Changes in International Knee Documentation Committee Scoring System (IKDC)
  time frame: 1 year (52 weeks), 2 years (104 weeks), and 3 years (156 weeks) after treatment
  description: A higher score indicates better function and less symptomatic
  measure: Evaluation of International K&L grade(X-ray)
  time frame: 1 year (52 weeks), 2 years (104 weeks), and 3 years (156 weeks) after treatment
  description: Grade 0 - No radioligical findings of osteoarthritis Grade 1 - Doubtful narrowing of joint space and possible osteophytic lipping Grade 2 - Definite osteophytes and possible narrowing of joint space Grade 3 - Moderate osteophytes, definite narrowing of joint space, and some sclerosis and deformity of bone ends Grade 4 - Large osteophytes, marked narrowing of joint space, severe sclerosis, and definite deformity of bone ends
  measure: Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) scores(MRI)
  time frame: 1 year (52 weeks), 2 years (104 weeks), and 3 years (156 weeks) after treatment
  description: A higher score indicates better function and less symptomatic
  measure: Whole-Organ Magnetic Resonance Imaging Score (WORMS) score
  time frame: 1 year (52 weeks), 2 years (104 weeks), and 3 years (156 weeks) after treatment
  description: The higher the score means normal state.
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 19 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Kyoung-Ho Yoon, professor (CI)
  role: Principal Investigator
  affiliation: Kyung Hee University Hospital
  last name: Sang Hak Lee, professor
  role: Principal Investigator
  affiliation: Gangdong Kyunghee University Hospital
  last name: Chaeeun JEON
  phone: 02-2036-7614
  email: cejeon@kangstem.com
  last name: Hyeseung JEON
  phone: 02-888-1592
  email: hsjeon@kangstem.com
  responsible party type: Sponsor
  mesh term: Osteoarthritis
  mesh term: Osteoarthritis, Knee