<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/NCT03291470</url>
  </required_header>
  <id_info>
    <org_study_id>TGC-15302</org_study_id>
    <nct_id>NCT03291470</nct_id>
  </id_info>
  <brief_title>Study to Determine the Efficacy and Safety of TG-C in Subjects With Kellgren/Lawrence Grade 2 or 3 OA of the Knee</brief_title>
  <official_title>A Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Phase 3 Study to Determine the Efficacy and Safety of TG-C in Subjects With Kellgren and Lawrence Grade 2 or 3 Osteoarthritis of the Knee</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kolon TissueGene, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Kolon TissueGene, Inc.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      A randomized, double-blind, placebo-controlled, multi-center, phase 3 study to determine the&#xD;
      efficacy and safety of TG-C in subjects with Kellgren and Lawrence Grade 2 or 3&#xD;
      Osteoarthritis of the Knee, Osteoarthritis Research Society International (OARSI) medial&#xD;
      joint space narrowing (JSN) Grade 1 or 2 of the knee joint. TG-C is to be administered by a&#xD;
      single intra-articular injection to the damaged joint area via ultrasound guidance. Patients&#xD;
      will be followed for 24 months for safety and efficacy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This protocol is designed to assess the safety and efficacy of TG-C in treating symptoms of&#xD;
      osteoarthritis of the knee and determining disease modifying effects of TG-C. This study is&#xD;
      intended for the treatment of patients with K&amp;L Grade 2 and 3 osteoarthritis and OARSI JSN&#xD;
      Grade 1 and 2. Assessments will be made on both the symptomatic effects of pain (VAS),&#xD;
      function (WOMAC), and Quality of Life (SF-12) as well as the physical effects (JSW, MRI&#xD;
      evaluations of whole knee joint organ tissues and structure) and biochemical biomarkers. This&#xD;
      is a placebo-controlled study, TG-C will be compared to normal saline as a control.&#xD;
      Additionally, this protocol is designed to evaluate the safety of TG-C. Safety will be&#xD;
      evaluated by observation of the injection site for irritation or other effects, the incidence&#xD;
      and severity of adverse events, and changes in physical examination findings, radiographic&#xD;
      criteria, and laboratory tests. Patients will be followed for 24 months for both safety and&#xD;
      efficacy with annual cancer surveillance questionnaires through 15 years post dose for&#xD;
      subjects who do not enroll in the Long Term Safety study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">December 9, 2021</start_date>
  <completion_date type="Anticipated">August 30, 2025</completion_date>
  <primary_completion_date type="Anticipated">August 30, 2024</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    <masking_description>Double-blind</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Knee Function as Assessed by the Western Ontario and McMaster Universities Index (WOMAC)</measure>
    <time_frame>12 months</time_frame>
    <description>Assessment of change from baseline in target knee function using the WOMAC Osteoarthritis Index. The WOMAC is a proprietary set of standardized questionnaires used by health professionals to evaluate the condition of patients with osteoarthritis of the knee including pain, stiffness, and physical functioning of the joints. The response to the questions is in the form of a checked box associated with the response; None, Mild, Moderate, Severe and Extreme.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Knee Pain as Assessed by VAS</measure>
    <time_frame>12 months</time_frame>
    <description>Assessment of change from baseline in target knee pain using the Visual Analog Scale (VAS). The VAS is a method for the assessment of the intensity of pain. The VAS is a horizontal line, 100 mm in length and anchored by word descriptors at each end (no pain, very severe pain). The patient marks on the line at the point that represents their current state. The VAS score is determined by measuring in millimeters from the left hand end to the point of the mark. The score ranges from &quot;0&quot; or no pain to &quot;100&quot; very severe pain.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>PCS of the SF-12 Questionnaire</measure>
    <time_frame>12 months</time_frame>
    <description>Evaluation of the change from baseline in physical component score (PCS) of the SF-12v2 questionnaire.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health Assessment Questionnaire Disability Index</measure>
    <time_frame>12 months</time_frame>
    <description>Evaluation of the change from baseline in the disability index of the Health Assessment Questionnaire (HAQ-DI)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>MRI Assessment of Target Knee</measure>
    <time_frame>12 months</time_frame>
    <description>Assessment of knee organ tissues and structure by comparing change in MRI scoring using WORMS and partial MRI Osteoarthritis Knee Score (MOAKS)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>WOMAC Total Score</measure>
    <time_frame>24 Months</time_frame>
    <description>Evaluation of the efficacy of TG-C with regard to knee function via WOMAC total score</description>
  </secondary_outcome>
  <other_outcome>
    <measure>OMERACT-OARSI Responder Analysis</measure>
    <time_frame>12 and 24 months</time_frame>
    <description>Analysis of response using the Outcomes Measures in Rheumatoid Arthritis Clinical Trials (OMERACT)-OARSI responder criteria</description>
  </other_outcome>
  <other_outcome>
    <measure>Radiography for Structural Change in Knee Joint</measure>
    <time_frame>24 months</time_frame>
    <description>Evaluate structural changes of the knee joint as determined by radiography (X-ray)</description>
  </other_outcome>
  <other_outcome>
    <measure>Efficacy of TG-C with Regard to Knee Function via WOMAC Total Score</measure>
    <time_frame>Week 1, Months 3, 6, 9, 12, 18, and 24</time_frame>
    <description>Evaluation of the efficacy of TG-C with regard to knee function via WOMAC total score</description>
  </other_outcome>
  <other_outcome>
    <measure>Efficacy of TG-C with Regard to Knee Function via WOMAC Pain, Function, and Stiffness Scores</measure>
    <time_frame>24 months</time_frame>
    <description>Evaluate the efficacy of TG-C with regard to knee function via WOMAC® pain, function, and stiffness scores</description>
  </other_outcome>
  <other_outcome>
    <measure>Efficacy of TG-C with Regard to Knee Function via VAS Pain Score</measure>
    <time_frame>Day 1, Week 1, and Months 1, 3, 6, 9, 18 and 24</time_frame>
    <description>Evaluation of the efficacy of TG-C with regard to knee function via VAS pain score at time points other than Month 12</description>
  </other_outcome>
  <other_outcome>
    <measure>European Quality of Life-Five Dimensions Questionnaire (EQ-5D-5L)</measure>
    <time_frame>Baseline and Months 3, 6, 9, 12, 18, and 24</time_frame>
    <description>Evaluate health outcomes using the European Quality of Life-Five Dimensions Questionnaire (EQ-5D-5L)</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">510</enrollment>
  <condition>Degenerative Osteoarthritis</condition>
  <arm_group>
    <arm_group_label>Active Treatment (TG-C)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>TG-C at 3 x 10e7 cells per single 2 mL intraarticular injection</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo Control (Normal Saline)</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Normal saline, single 2 mL intraarticular injection</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>TG-C</intervention_name>
    <description>2 mL injection of non-transduced human chondrocytes and irradiated transduced human GP2-293 cells expressing TGF-B1</description>
    <arm_group_label>Active Treatment (TG-C)</arm_group_label>
    <other_name>TissueGene-C</other_name>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Placebo Control</intervention_name>
    <description>2 mL normal saline intraarticular injection</description>
    <arm_group_label>Placebo Control (Normal Saline)</arm_group_label>
    <other_name>Normal Saline</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Aged 40 or older&#xD;
&#xD;
          -  BMI between 18.5 and 40&#xD;
&#xD;
          -  KL Grade 2 or 3 knee OA&#xD;
&#xD;
          -  OARSI Grade 1 or 2 medial JSN&#xD;
&#xD;
          -  Pain &gt;= 40 on VAS scale&#xD;
&#xD;
          -  Written informed consent&#xD;
&#xD;
          -  Using birth control&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Knee symptoms that result in difficulty or inability to walk&#xD;
&#xD;
          -  Knee effusion &gt;2+&#xD;
&#xD;
          -  Has Grade 3 OARSI JSN&#xD;
&#xD;
          -  MRI exam indicates fracture or tumor&#xD;
&#xD;
          -  Has a positive result on RCR testing at screening&#xD;
&#xD;
          -  Has taken NSAIDS with 14 days of baseline&#xD;
&#xD;
          -  Has taken steroidal anti-inflammatory or biologic therapy medication within 2 months&#xD;
             of baseline&#xD;
&#xD;
          -  Chronic (&gt;21 days) narcotic use&#xD;
&#xD;
          -  Recent history (within 1 year) of drug or alcohol abuse&#xD;
&#xD;
          -  Pregnant or lactating&#xD;
&#xD;
          -  Has received injection to target knee within 2 months prior to study entry&#xD;
&#xD;
          -  History of various disorders of the knee including but not limited to rheumatoid&#xD;
             arthritis, psoriatic arthritis, autoimmune disorder, chondrocalcinosis, gout,&#xD;
             hemochromatosis, villonodular synovitis, or synovial chondromatosis&#xD;
&#xD;
          -  Severe hip osteoarthritis ipsilateral to the target knee&#xD;
&#xD;
          -  Ongoing infectious disease including but not limited to HIV, HTLV-1, VSV-G, HBV, or&#xD;
             HCV.&#xD;
&#xD;
          -  Clinically significant congestive heart failure, hepatic disease, kidney disease,&#xD;
             adrenal insufficiency, acromegaly, uncontrolled hyper- or hypothyroidism, or&#xD;
             non-specified uncontrolled endocrine disorder.&#xD;
&#xD;
          -  Uncontrolled diabetes based on a HbA1c &gt; 8% at screening.&#xD;
&#xD;
          -  Documented active malignancy within the last 5 years except for basal cell carcinoma,&#xD;
             squamous cell carcinoma, and benign pigmented nevi.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Moon Jong Noh, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Kolon TissueGene</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Aaron Harrison</last_name>
    <phone>(910) 399-3238</phone>
    <email>KTGclinical@tissuegene.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Hayes Williams</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35216</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>John Tesser</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85032</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Nebojsa Skrepnik</name>
      <address>
        <city>Tucson</city>
        <state>Arizona</state>
        <zip>85712</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>George Konis</name>
      <address>
        <city>Little Rock</city>
        <state>Arkansas</state>
        <zip>72211</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Steve Sitar</name>
      <address>
        <city>Anaheim</city>
        <state>California</state>
        <zip>92801</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Stuart Silverman</name>
      <address>
        <city>Beverly Hills</city>
        <state>California</state>
        <zip>90211</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Samy Metyas</name>
      <address>
        <city>Covina</city>
        <state>California</state>
        <zip>91722</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Bassil Aish</name>
      <address>
        <city>Huntington Beach</city>
        <state>California</state>
        <zip>92647</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Peter Hanson</name>
      <address>
        <city>La Mesa</city>
        <state>California</state>
        <zip>91942</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Natalia Chavez Stewart</name>
      <address>
        <city>Riverside</city>
        <state>California</state>
        <zip>92518</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>John Beckes</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92120</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Miguel Trevino</name>
      <address>
        <city>Clearwater</city>
        <state>Florida</state>
        <zip>33756</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Jan Hommen</name>
      <address>
        <city>Doral</city>
        <state>Florida</state>
        <zip>33126</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Mira Baron</name>
      <address>
        <city>West Palm Beach</city>
        <state>Florida</state>
        <zip>33409</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Richard Radnovich</name>
      <address>
        <city>Boise</city>
        <state>Idaho</state>
        <zip>83713</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Thomas Schnitzer</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60611</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Joel Block</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60612</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Nathan Rimmke</name>
      <address>
        <city>Rochester Hills</city>
        <state>Michigan</state>
        <zip>48307</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Larkin Wadsworth</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63141</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Duane C Anderson</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89109</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Igor Grosman</name>
      <address>
        <city>Brooklyn</city>
        <state>New York</state>
        <zip>11235</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Jonathan Samuels</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10016</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>John Solic</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27704</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Rakesh Patel</name>
      <address>
        <city>Salisbury</city>
        <state>North Carolina</state>
        <zip>28144</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Jeremy Hoff</name>
      <address>
        <city>Wilmington</city>
        <state>North Carolina</state>
        <zip>28412</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Priyesh Mehta</name>
      <address>
        <city>Dayton</city>
        <state>Ohio</state>
        <zip>45432</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Edward Tavel</name>
      <address>
        <city>Charleston</city>
        <state>South Carolina</state>
        <zip>29406</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Howsen Kwan</name>
      <address>
        <city>Carrollton</city>
        <state>Texas</state>
        <zip>75006</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
  </location>
  <location>
    <facility>
      <name>James Lilly</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75230</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Manjoo Sharma</name>
      <address>
        <city>Lewisville</city>
        <state>Texas</state>
        <zip>75057</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Haresh Boghara</name>
      <address>
        <city>Red Oak</city>
        <state>Texas</state>
        <zip>75154</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Leonel Reyes</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78215</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Charles Andrews</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78229</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Maninder Guram</name>
      <address>
        <city>Tomball</city>
        <state>Texas</state>
        <zip>77375</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>David Scott</name>
      <address>
        <city>Spokane</city>
        <state>Washington</state>
        <zip>99218</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>September 19, 2017</study_first_submitted>
  <study_first_submitted_qc>September 19, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 25, 2017</study_first_posted>
  <last_update_submitted>July 6, 2023</last_update_submitted>
  <last_update_submitted_qc>July 6, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 7, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>knee</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osteoarthritis</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/NCT03291470
org study id: TGC-15302
nct id: NCT03291470
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
A randomized, double-blind, placebo-controlled, multi-center, phase 3 study to determine the
      efficacy and safety of TG-C in subjects with Kellgren and Lawrence Grade 2 or 3
      Osteoarthritis of the Knee, Osteoarthritis Research Society International (OARSI) medial
      joint space narrowing (JSN) Grade 1 or 2 of the knee joint. TG-C is to be administered by a
      single intra-articular injection to the damaged joint area via ultrasound guidance. Patients
      will be followed for 24 months for safety and efficacy.
This protocol is designed to assess the safety and efficacy of TG-C in treating symptoms of
      osteoarthritis of the knee and determining disease modifying effects of TG-C. This study is
      intended for the treatment of patients with K&L Grade 2 and 3 osteoarthritis and OARSI JSN
      Grade 1 and 2. Assessments will be made on both the symptomatic effects of pain (VAS),
      function (WOMAC), and Quality of Life (SF-12) as well as the physical effects (JSW, MRI
      evaluations of whole knee joint organ tissues and structure) and biochemical biomarkers. This
      is a placebo-controlled study, TG-C will be compared to normal saline as a control.
      Additionally, this protocol is designed to evaluate the safety of TG-C. Safety will be
      evaluated by observation of the injection site for irritation or other effects, the incidence
      and severity of adverse events, and changes in physical examination findings, radiographic
      criteria, and laboratory tests. Patients will be followed for 24 months for both safety and
      efficacy with annual cancer surveillance questionnaires through 15 years post dose for
      subjects who do not enroll in the Long Term Safety study.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
masking description: Double-blind
measure: Change in Knee Function as Assessed by the Western Ontario and McMaster Universities Index (WOMAC)
time frame: 12 months
description: Assessment of change from baseline in target knee function using the WOMAC Osteoarthritis Index. The WOMAC is a proprietary set of standardized questionnaires used by health professionals to evaluate the condition of patients with osteoarthritis of the knee including pain, stiffness, and physical functioning of the joints. The response to the questions is in the form of a checked box associated with the response; None, Mild, Moderate, Severe and Extreme.
measure: Change in Knee Pain as Assessed by VAS
time frame: 12 months
description: Assessment of change from baseline in target knee pain using the Visual Analog Scale (VAS). The VAS is a method for the assessment of the intensity of pain. The VAS is a horizontal line, 100 mm in length and anchored by word descriptors at each end (no pain, very severe pain). The patient marks on the line at the point that represents their current state. The VAS score is determined by measuring in millimeters from the left hand end to the point of the mark. The score ranges from "0" or no pain to "100" very severe pain.
measure: PCS of the SF-12 Questionnaire
time frame: 12 months
description: Evaluation of the change from baseline in physical component score (PCS) of the SF-12v2 questionnaire.
measure: Health Assessment Questionnaire Disability Index
time frame: 12 months
description: Evaluation of the change from baseline in the disability index of the Health Assessment Questionnaire (HAQ-DI)
measure: MRI Assessment of Target Knee
time frame: 12 months
description: Assessment of knee organ tissues and structure by comparing change in MRI scoring using WORMS and partial MRI Osteoarthritis Knee Score (MOAKS)
measure: WOMAC Total Score
time frame: 24 Months
description: Evaluation of the efficacy of TG-C with regard to knee function via WOMAC total score
measure: OMERACT-OARSI Responder Analysis
time frame: 12 and 24 months
description: Analysis of response using the Outcomes Measures in Rheumatoid Arthritis Clinical Trials (OMERACT)-OARSI responder criteria
measure: Radiography for Structural Change in Knee Joint
time frame: 24 months
description: Evaluate structural changes of the knee joint as determined by radiography (X-ray)
measure: Efficacy of TG-C with Regard to Knee Function via WOMAC Total Score
time frame: Week 1, Months 3, 6, 9, 12, 18, and 24
description: Evaluation of the efficacy of TG-C with regard to knee function via WOMAC total score
measure: Efficacy of TG-C with Regard to Knee Function via WOMAC Pain, Function, and Stiffness Scores
time frame: 24 months
description: Evaluate the efficacy of TG-C with regard to knee function via WOMAC® pain, function, and stiffness scores
measure: Efficacy of TG-C with Regard to Knee Function via VAS Pain Score
time frame: Day 1, Week 1, and Months 1, 3, 6, 9, 18 and 24
description: Evaluation of the efficacy of TG-C with regard to knee function via VAS pain score at time points other than Month 12
measure: European Quality of Life-Five Dimensions Questionnaire (EQ-5D-5L)
time frame: Baseline and Months 3, 6, 9, 12, 18, and 24
description: Evaluate health outcomes using the European Quality of Life-Five Dimensions Questionnaire (EQ-5D-5L)
arm group label: Active Treatment (TG-C)
arm group type: Active Comparator
description: TG-C at 3 x 10e7 cells per single 2 mL intraarticular injection
arm group label: Placebo Control (Normal Saline)
arm group type: Placebo Comparator
description: Normal saline, single 2 mL intraarticular injection
intervention type: Biological
intervention name: TG-C
description: 2 mL injection of non-transduced human chondrocytes and irradiated transduced human GP2-293 cells expressing TGF-B1
arm group label: Active Treatment (TG-C)
other name: TissueGene-C
intervention type: Biological
intervention name: Placebo Control
description: 2 mL normal saline intraarticular injection
arm group label: Placebo Control (Normal Saline)
other name: Normal Saline
criteria: 
gender: All
minimum age: 40 Years
maximum age: N/A
healthy volunteers: No
last name: Moon Jong Noh, PhD
role: Study Chair
affiliation: Kolon TissueGene
last name: Aaron Harrison
phone: (910) 399-3238
email: KTGclinical@tissuegene.com
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country: United States
responsible party type: Sponsor
mesh term: Osteoarthritis
sharing ipd: No