<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/NCT04470167</url>
  </required_header>
  <id_info>
    <org_study_id>TG-TPX-115-20-01</org_study_id>
    <nct_id>NCT04470167</nct_id>
  </id_info>
  <brief_title>Phase 1/2 Clinical Study of TPX-115 in Patients With Partial-Thickness Rotator Cuff Tear</brief_title>
  <official_title>A Multi-center, Randomized, Independent Evaluator-blinded, Subject-blinded, Placebo-controlled, Phase 1/2 Clinical Study to Evaluate Safety and Efficacy of TPX-115 in Patients With Partial-Thickness Rotator Cuff Tear</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tego Science, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Tego Science, Inc.</source>
  <oversight_info>
    <has_dmc>No</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>
      Rotator cuff tear is one of the most common shoulder diseases and conservative treatment is&#xD;
      commonly used for tears involving ≤50% of tendon thickness. Since conventional conservative&#xD;
      treatments are not fundamental to repair tendon tissue, there is a growing need of new&#xD;
      therapy to improve structural outcome. This study assesses the safety and efficacy of&#xD;
      allogeneic fibroblasts on partial-thickness rotator cuff tear. The primary outcome is change&#xD;
      in American Shoulder and Elbow Surgeons (ASES) score at 24 weeks after TPX-115 injection.&#xD;
      Secondary outcomes include changes from baseline in Visual Analogue Score (VAS) pain score,&#xD;
      functional evaluations including Range of Motion (ROM), Constant Score (CS), ASES score and&#xD;
      Simple Shoulder Test (SST) at 4, 12 and 24 weeks after administration and structural&#xD;
      evaluation using MRI at 24 weeks after injection.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 26, 2020</start_date>
  <completion_date type="Actual">February 17, 2022</completion_date>
  <primary_completion_date type="Actual">February 17, 2022</primary_completion_date>
  <phase>Phase 1/Phase 2</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>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in shoulder score of American Shoulder and Elbow Surgeons (ASES)</measure>
    <time_frame>24 weeks</time_frame>
    <description>ASES shoulder score is derived from the Visual Analogue Scale (VAS) score for pain and activities of daily living score. The total score - maximum of 100 points - is weighted 50% for pain and 50% for function.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in shoulder score of American Shoulder and Elbow Surgeons (ASES)</measure>
    <time_frame>4, 12 weeks</time_frame>
    <description>ASES shoulder score is derived from the Visual Analogue Scale (VAS) score for pain and the activities of daily living score. The total score - maximum of points - is weighted 50% for pain and 50% for function.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in pain score of Visual Analogue Scale (VAS)</measure>
    <time_frame>4, 12, 24 weeks</time_frame>
    <description>VAS pain score is measured on a scale of 0 (no pain) to 10 (worst pain imaginable).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Range of Motion (ROM)</measure>
    <time_frame>4, 12, 24 weeks</time_frame>
    <description>Measurement of ROM for forward elevation, external rotation at 90º abduction, external rotation at side and internal rotation at back.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Constant score (CS)</measure>
    <time_frame>4, 12, 24 weeks</time_frame>
    <description>The CS total score (100) = Pain (15) + Activity of Daily Living (20) + Mobility (40) + Strength(25)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Simple Shoulder Test (SST) Score</measure>
    <time_frame>4, 12, 24 weeks</time_frame>
    <description>SST assesses functional disability of the shoulder (function related to pain, function/strength and Range of Motion).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in tear size on Magnetic Resonance Image (MRI)</measure>
    <time_frame>24 weeks</time_frame>
    <description>Tear size is assessed by an independent evaluator.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in tendon thickness on Magnetic Resonance Image (MRI)</measure>
    <time_frame>24 weeks</time_frame>
    <description>Tendon thickness is assessed by an independent evaluator.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in tear/footprint on MRI</measure>
    <time_frame>24 weeks</time_frame>
    <description>Ratio of tear lengths to whole footprint length is measured by an independent evaluator.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of tendinosis on MRI</measure>
    <time_frame>24 weeks</time_frame>
    <description>Tendinosis is assessed with tendinosis grading system by an independent evaluator. (0: normal, 1: mild, 2: moderate, 3: marked)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">49</enrollment>
  <condition>Rotator Cuff Injuries</condition>
  <arm_group>
    <arm_group_label>TPX-115</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects receive ultrasound-guided intratendinous injection of TPX-115</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Subjects receive ultrasound-guided intratendinous placebo injection</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>TPX-115</intervention_name>
    <description>Ultrasound-guided intratendinous injection of allogeneic fibroblasts(TPX-115)</description>
    <arm_group_label>TPX-115</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Ultrasound-guided intratendinous placebo injection</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Participants must;&#xD;
&#xD;
          1. Be 19 years of age or older.&#xD;
&#xD;
          2. Have partial-thickness rotator cuff tear, ≤50% of tendon thickness or of Ellman grade&#xD;
             I, II assessed by MRI.&#xD;
&#xD;
          3. Have unilateral shoulder pain lasting more than 3 months despite conservative&#xD;
             treatment and VAS pain score ≥5 at screening.&#xD;
&#xD;
          4. Understand fully the study and voluntarily sign the informed consent for participation&#xD;
             in the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Participants with any of the following conditions will be excluded unless stated otherwise;&#xD;
&#xD;
          1. Have partial-thickness rotator cuff tear larger than 50% of tendon thickness or of&#xD;
             Ellman grade III, or full-thickness rotator cuff tear confirmed by MRI.&#xD;
&#xD;
          2. Have prior medical history of shoulder surgery on the torn rotator cuff or the upper&#xD;
             part of shoulder within 6 months prior to screening visit (shoulder trauma, fracture,&#xD;
             upper cervical spine surgery, etc.).&#xD;
&#xD;
          3. Have had subacromial or intra-articular injections on the affected shoulder within 3&#xD;
             months prior to screening visit.&#xD;
&#xD;
          4. Have had received systemic steroid or immunosuppressive agents within 4 weeks prior to&#xD;
             screening visit.&#xD;
&#xD;
          5. Have been diagnosed with the following diseases.&#xD;
&#xD;
               -  Inflammatory joint diseases&#xD;
&#xD;
               -  Other shoulder diseases which may cause shoulder pain or functional disorder&#xD;
&#xD;
               -  Autoimmune diseases&#xD;
&#xD;
               -  Active hepatitis B or C&#xD;
&#xD;
               -  HIV Ab positive&#xD;
&#xD;
               -  Malignant tumors within the last 5 years&#xD;
&#xD;
               -  Coagulopathy&#xD;
&#xD;
               -  Genetic disorders related to fibroblasts of collagen&#xD;
&#xD;
               -  Other serious diseases deemed to affect the results of the study&#xD;
&#xD;
          6. Have allergies to bovine proteins or gentamicin.&#xD;
&#xD;
          7. Be pregnant, breastfeeding, planning pregnancy or unwilling to use of contraceptive&#xD;
             suggested in this study.&#xD;
&#xD;
          8. Have participated in other clinical trials and received investigational agents within&#xD;
             4 weeks of this study&#xD;
&#xD;
          9. Be deemed inadequate for the study by investigators.&#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>Joo Han Oh, Ph.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>Seoul National University Bundang Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Seoul National University Bundang Hospital</name>
      <address>
        <city>Seongnam-si</city>
        <state>Gyeonggi-do</state>
        <zip>13620</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Seoul National University Hospital</name>
      <address>
        <city>Seoul</city>
        <zip>03080</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>July 3, 2020</study_first_submitted>
  <study_first_submitted_qc>July 13, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 14, 2020</study_first_posted>
  <last_update_submitted>May 17, 2023</last_update_submitted>
  <last_update_submitted_qc>May 17, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 18, 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>Rotator Cuff Injuries</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/NCT04470167
org study id: TG-TPX-115-20-01
nct id: NCT04470167
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Rotator cuff tear is one of the most common shoulder diseases and conservative treatment is
      commonly used for tears involving ≤50% of tendon thickness. Since conventional conservative
      treatments are not fundamental to repair tendon tissue, there is a growing need of new
      therapy to improve structural outcome. This study assesses the safety and efficacy of
      allogeneic fibroblasts on partial-thickness rotator cuff tear. The primary outcome is change
      in American Shoulder and Elbow Surgeons (ASES) score at 24 weeks after TPX-115 injection.
      Secondary outcomes include changes from baseline in Visual Analogue Score (VAS) pain score,
      functional evaluations including Range of Motion (ROM), Constant Score (CS), ASES score and
      Simple Shoulder Test (SST) at 4, 12 and 24 weeks after administration and structural
      evaluation using MRI at 24 weeks after injection.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Change in shoulder score of American Shoulder and Elbow Surgeons (ASES)
time frame: 24 weeks
description: ASES shoulder score is derived from the Visual Analogue Scale (VAS) score for pain and activities of daily living score. The total score - maximum of 100 points - is weighted 50% for pain and 50% for function.
measure: Change in shoulder score of American Shoulder and Elbow Surgeons (ASES)
time frame: 4, 12 weeks
description: ASES shoulder score is derived from the Visual Analogue Scale (VAS) score for pain and the activities of daily living score. The total score - maximum of points - is weighted 50% for pain and 50% for function.
measure: Change in pain score of Visual Analogue Scale (VAS)
time frame: 4, 12, 24 weeks
description: VAS pain score is measured on a scale of 0 (no pain) to 10 (worst pain imaginable).
measure: Change in Range of Motion (ROM)
time frame: 4, 12, 24 weeks
description: Measurement of ROM for forward elevation, external rotation at 90º abduction, external rotation at side and internal rotation at back.
measure: Change in Constant score (CS)
time frame: 4, 12, 24 weeks
description: The CS total score (100) = Pain (15) + Activity of Daily Living (20) + Mobility (40) + Strength(25)
measure: Change in Simple Shoulder Test (SST) Score
time frame: 4, 12, 24 weeks
description: SST assesses functional disability of the shoulder (function related to pain, function/strength and Range of Motion).
measure: Change in tear size on Magnetic Resonance Image (MRI)
time frame: 24 weeks
description: Tear size is assessed by an independent evaluator.
measure: Change in tendon thickness on Magnetic Resonance Image (MRI)
time frame: 24 weeks
description: Tendon thickness is assessed by an independent evaluator.
measure: Change in tear/footprint on MRI
time frame: 24 weeks
description: Ratio of tear lengths to whole footprint length is measured by an independent evaluator.
measure: Change of tendinosis on MRI
time frame: 24 weeks
description: Tendinosis is assessed with tendinosis grading system by an independent evaluator. (0: normal, 1: mild, 2: moderate, 3: marked)
arm group label: TPX-115
arm group type: Experimental
description: Subjects receive ultrasound-guided intratendinous injection of TPX-115
arm group label: Placebo
arm group type: Placebo Comparator
description: Subjects receive ultrasound-guided intratendinous placebo injection
intervention type: Biological
intervention name: TPX-115
description: Ultrasound-guided intratendinous injection of allogeneic fibroblasts(TPX-115)
arm group label: TPX-115
intervention type: Other
intervention name: Placebo
description: Ultrasound-guided intratendinous placebo injection
arm group label: Placebo
criteria: 
gender: All
minimum age: 19 Years
maximum age: N/A
healthy volunteers: No
last name: Joo Han Oh, Ph.D
role: Principal Investigator
affiliation: Seoul National University Bundang Hospital
facility: 
facility: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Rotator Cuff Injuries
sharing ipd: No