<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/NCT03839238</url>
  </required_header>
  <id_info>
    <org_study_id>Wuhan Tongji Hospital</org_study_id>
    <nct_id>NCT03839238</nct_id>
  </id_info>
  <brief_title>Safety Observation on hESC Derived MSC Like Cell for the Meniscus Injury</brief_title>
  <official_title>Safety Observation on Human Embryonic Stem Cell (hESC) Derived Mesenchymal Stem Cells(MSC) Like Cell for the Meniscus Injury</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tongji Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Chinese Academy of Sciences</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Tongji Hospital</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>
      human embryonic stem cell derived mesenchymal stem cells like cell for the meniscus injury,&#xD;
      and observe the safety of the cells for meniscus injury&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Three different dosage of human embryonic stem cell derived mesenchymal stem cells like for&#xD;
      meniscus injury patients, and observe the safety of the cells for meniscus injury.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">January 4, 2019</start_date>
  <completion_date type="Anticipated">September 30, 2020</completion_date>
  <primary_completion_date type="Anticipated">June 30, 2020</primary_completion_date>
  <phase>Phase 1</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>The change in number of adverse events based on the National Cancer Institute-Common Terminology Criteria for Adverse Events</measure>
    <time_frame>1 week, 1 month, 2months and 3 months after the injection of MSC Like Cell</time_frame>
    <description>Adverse events include：allergic reactions, local reactions or infections at the injection site and muscle or skeletal dysplasia</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Ultrasound of knee joint</measure>
    <time_frame>baseline, 1 week, 1 month, 2months and 3 months after the injection of MSC Like Cell</time_frame>
    <description>Ultrasound of knee joint</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Visual Analog Score for pain（VAS）</measure>
    <time_frame>baseline, 1 week, 1 month, 2months and 3 months after the injection of MSC Like Cell</time_frame>
    <description>VAS is a psychometric response scale which can be used in questionnaires. It is a measurement instrument for subjective pain. The scale range is from 0 to 10, the higher the score, the more severe the pain.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Range of knee motion</measure>
    <time_frame>baseline, 1 week, 1 month, 2months and 3 months after the injection of MSC Like Cell</time_frame>
    <description>to use the goniometer to measure the range of knee motion</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lysholm Knee Scale</measure>
    <time_frame>baseline, 1 week, 1 month, 2months and 3 months after the injection of MSC Like Cell</time_frame>
    <description>The scale is to assess the function of knee. The scale range is from 0 to 100, the higher the score, the more severe the knee problems. This scale includes 8 items, and the total score is the sum of these 8 items' scores. Individual items are scored differently, using individual scoring scales: 1. limp (0,3,5), 2. support (0,2,5), 3. locking (0,2,6,10,15), 4. instability (0,5,10,15,20,25), 5. pain (0,5,10,15,20,25), 6. swelling (0,2,6,10), 7. stair climbing (0,2,6,10), 8. squatting (0,2,4,5).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>MRI of knee</measure>
    <time_frame>baseline, 1 week, 1 month, 2months and 3 months after the injection of MSC Like Cell</time_frame>
    <description>MRI of knee</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Global posture analysis system</measure>
    <time_frame>baseline, 1 week, 1 month, 2months and 3 months after the injection of MSC Like Cell</time_frame>
    <description>to test the static balance</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dynamic balance test</measure>
    <time_frame>baseline, 1 week, 1 month, 2months and 3 months after the injection of MSC Like Cell</time_frame>
    <description>Use the dynamic posture evaluator</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">18</enrollment>
  <condition>Meniscus Injury</condition>
  <arm_group>
    <arm_group_label>Meniscus Injured patients</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>hESC Derived MSC Like Cell</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>hESC derived MSC like cell</intervention_name>
    <description>Different dosage of hESC derived MSC like cell for the meniscus injured patients</description>
    <arm_group_label>Meniscus Injured patients</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Grade Ⅰ-Ⅱ meniscus injury of knee joint&#xD;
&#xD;
          -  The patients who still have the pain of knee joint and/or limitation of the function&#xD;
             after accepted 3 months of nonoperative treatment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Recent history of lower limb fractures or intra-articular drug injection&#xD;
&#xD;
          -  The patients who have meniscus injury of knee joint need the surgical repair&#xD;
&#xD;
          -  The patients who have the severe coagulation disorders, cardiopulmonary failure and so&#xD;
             on&#xD;
&#xD;
          -  The women who are pregnant or nursing&#xD;
&#xD;
          -  There are electronic implants such as pacemakers in the body&#xD;
&#xD;
          -  The patients who are infected the HIV, the virus of hepatitis or syphilis&#xD;
&#xD;
          -  The patients who are alcoholism or drug user&#xD;
&#xD;
          -  The patients who have vestibular and balance disorders&#xD;
&#xD;
          -  The patients with severe cognitive impairment who cannot follow instructions to&#xD;
             complete the treatment&#xD;
&#xD;
          -  The patients who don't sign the informed consent&#xD;
&#xD;
          -  The patients who have tumor&#xD;
&#xD;
          -  Immunodeficiency patients&#xD;
&#xD;
          -  The patients who have congenital or acquired knee malformation&#xD;
&#xD;
          -  Patients or researchers who are participating in other clinical trials believe that&#xD;
             other reasons are not appropriate for clinical trials&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hong Chen, Doctor</last_name>
    <role>Study Director</role>
    <affiliation>Wuhan TongJi Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Tongji Hospital, Tongji Medical College of Science and Technology</name>
      <address>
        <city>Wuhan</city>
        <state>Hubei</state>
        <zip>430030</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>November 28, 2018</study_first_submitted>
  <study_first_submitted_qc>February 10, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 15, 2019</study_first_posted>
  <last_update_submitted>February 10, 2019</last_update_submitted>
  <last_update_submitted_qc>February 10, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 15, 2019</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>Wounds and Injuries</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/NCT03839238
org study id: Wuhan Tongji Hospital
nct id: NCT03839238
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
human embryonic stem cell derived mesenchymal stem cells like cell for the meniscus injury,
      and observe the safety of the cells for meniscus injury
Three different dosage of human embryonic stem cell derived mesenchymal stem cells like for
      meniscus injury patients, and observe the safety of the cells for meniscus injury.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: The change in number of adverse events based on the National Cancer Institute-Common Terminology Criteria for Adverse Events
time frame: 1 week, 1 month, 2months and 3 months after the injection of MSC Like Cell
description: Adverse events include：allergic reactions, local reactions or infections at the injection site and muscle or skeletal dysplasia
measure: Ultrasound of knee joint
time frame: baseline, 1 week, 1 month, 2months and 3 months after the injection of MSC Like Cell
description: Ultrasound of knee joint
measure: Visual Analog Score for pain（VAS）
time frame: baseline, 1 week, 1 month, 2months and 3 months after the injection of MSC Like Cell
description: VAS is a psychometric response scale which can be used in questionnaires. It is a measurement instrument for subjective pain. The scale range is from 0 to 10, the higher the score, the more severe the pain.
measure: Range of knee motion
time frame: baseline, 1 week, 1 month, 2months and 3 months after the injection of MSC Like Cell
description: to use the goniometer to measure the range of knee motion
measure: Lysholm Knee Scale
time frame: baseline, 1 week, 1 month, 2months and 3 months after the injection of MSC Like Cell
description: The scale is to assess the function of knee. The scale range is from 0 to 100, the higher the score, the more severe the knee problems. This scale includes 8 items, and the total score is the sum of these 8 items' scores. Individual items are scored differently, using individual scoring scales: 1. limp (0,3,5), 2. support (0,2,5), 3. locking (0,2,6,10,15), 4. instability (0,5,10,15,20,25), 5. pain (0,5,10,15,20,25), 6. swelling (0,2,6,10), 7. stair climbing (0,2,6,10), 8. squatting (0,2,4,5).
measure: MRI of knee
time frame: baseline, 1 week, 1 month, 2months and 3 months after the injection of MSC Like Cell
description: MRI of knee
measure: Global posture analysis system
time frame: baseline, 1 week, 1 month, 2months and 3 months after the injection of MSC Like Cell
description: to test the static balance
measure: Dynamic balance test
time frame: baseline, 1 week, 1 month, 2months and 3 months after the injection of MSC Like Cell
description: Use the dynamic posture evaluator
arm group label: Meniscus Injured patients
arm group type: Experimental
description: hESC Derived MSC Like Cell
intervention type: Biological
intervention name: hESC derived MSC like cell
description: Different dosage of hESC derived MSC like cell for the meniscus injured patients
arm group label: Meniscus Injured patients
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Hong Chen, Doctor
role: Study Director
affiliation: Wuhan TongJi Hospital
facility: 
country: China
responsible party type: Sponsor
mesh term: Wounds and Injuries