<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/NCT03028428</url>
  </required_header>
  <id_info>
    <org_study_id>AHJiangsuU-FSK-MSC-OA</org_study_id>
    <nct_id>NCT03028428</nct_id>
  </id_info>
  <brief_title>Intra-articular Injection of MSCs in Treatment of Knee OA</brief_title>
  <official_title>Clinical Research on Intra-articular Injection of Human Autologous MSCs in Treatment of Knee OA</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Affiliated Hospital of Jiangsu University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Affiliated Hospital of Jiangsu University</source>
  <brief_summary>
    <textblock>
      In this study, researchers want to determine the safety of MSCs that a patient can tolerate&#xD;
      without causing side effects. Moreover researchers will also be looking at the function of&#xD;
      the knee over time, which may give them some insight on the usefulness of MSCs as a treatment&#xD;
      option.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Osteoarthritis (OA) is one of the most common forms of arthritis. It is a lasting condition&#xD;
      in which the material that cushions the joints, called cartilage, breaks down. This causes&#xD;
      the bones to rub against each other, causing inflammation, stiffness, pain and loss of joint&#xD;
      movement. Currently, there are few effective treatments available for patients suffering from&#xD;
      OA.&#xD;
&#xD;
      Mesenchymal stem cells (MSCs) are cells that have the ability to self-regenerate, which means&#xD;
      they have the ability to make copies of themselves and to turn into other kinds of cells&#xD;
      (e.g. cartilage cells). Stem cell science shows much promise for the future treatment of&#xD;
      osteoarthritis, but much of the research is still in the early stages. In this study,&#xD;
      researchers want to determine the safety of MSCs that a patient can tolerate without causing&#xD;
      side effects. Moreover researchers will also be looking at the function of the knee over&#xD;
      time, which may give them some insight on the usefulness of MSCs as a treatment option.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>December 2016</start_date>
  <completion_date type="Anticipated">December 2019</completion_date>
  <primary_completion_date type="Anticipated">December 2018</primary_completion_date>
  <phase>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>
    <intervention_model_description>A Randomized, Double Blind, Phase-II Study Assessing the Safety and Efficacy of Intraarticular Ex-vivo Cultured Adult Allogeneic Mesenchymal Stem Cells in Patients with Osteoarthritis of Knee</intervention_model_description>
    <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>adverse events</measure>
    <time_frame>1 Year</time_frame>
    <description>Number of participants with adverse events as measure of safety and tolerability</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>radiographic evidence</measure>
    <time_frame>1 Year</time_frame>
    <description>Number of participants with a change in cartilage thickness of knee OA using MRI</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>WOMAC assessment</measure>
    <time_frame>1 Year</time_frame>
    <description>Number of participants with a change in joint function from baseline WOMAC assessment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>VAS</measure>
    <time_frame>1 Year</time_frame>
    <description>Number of participants with a change in arthritis pain scores on the visual analogue scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>SF-36</measure>
    <time_frame>1 Year</time_frame>
    <description>Number of participants with a change in SF-36</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">1</enrollment>
  <condition>Osteoarthritis</condition>
  <condition>Stem Cells</condition>
  <condition>MSC</condition>
  <arm_group>
    <arm_group_label>Placenta Derived Mesenchymal Stem Cell</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Placenta Derived Mesenchymal Stem Cell administered into the knee joint once</description>
  </arm_group>
  <arm_group>
    <arm_group_label>sodium hyaluronate</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Sodium hyaluronate administered into the knee joint once</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Placenta Derived Mesenchymal Stem Cell</intervention_name>
    <description>1ml 1*10^7 Placenta Derived Mesenchymal Stem Cell administered into the knee joint once</description>
    <arm_group_label>Placenta Derived Mesenchymal Stem Cell</arm_group_label>
    <other_name>Mesenchymal Stromal Cells (MSCs)</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Sodium Hyaluronate</intervention_name>
    <description>Sodium hyaluronate administered into the knee joint once</description>
    <arm_group_label>sodium hyaluronate</arm_group_label>
    <other_name>hyaluronate</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients between 40-75 years of age with symptomatic moderate to severe&#xD;
             (Kellgren-Lawrence III or IV) primary osteoarthritis of the knee&#xD;
&#xD;
          2. Idiopathic or secondary osteoarthritis of the knee with grade 2,3, or 4 radiographic&#xD;
             severity, as defined by the modified Kellgren-Lawrence classification&#xD;
&#xD;
          3. No history of prior intra-articular cortisone, hyaluronic acid, or platelet-rich&#xD;
             plasma injection within the previous six months&#xD;
&#xD;
          4. No history of prior arthroscopic knee surgery or open knee surgery on the ipsilateral&#xD;
             side within the past year&#xD;
&#xD;
          5. Adequate bone marrow, liver, and renal functions&#xD;
&#xD;
          6. Body weight &gt;40 kg&#xD;
&#xD;
          7. Body Mass Index &lt;40&#xD;
&#xD;
          8. Negative for (HIV, HTLV1&amp;2, Hep A, B, C, syphilis) infection as determined by approved&#xD;
             serological testing&#xD;
&#xD;
          9. Negative for pregnancy as determined by a serum pregnancy test. Females of&#xD;
             childbearing potential will be required to practice abstinence or use an effective&#xD;
             form of contraception for 12 months following their MSC injection.&#xD;
&#xD;
         10. Ability to provide written informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients with clinically unstable knee due to the presence of a complete anterior&#xD;
             cruciate ligament, posterior cruciate ligament, medial collateral ligament and/or&#xD;
             posterolateral corner tear&#xD;
&#xD;
          2. Patients with varus or valgus malalignment &gt;5 degrees as measured by 4 foot standing&#xD;
             antero-posterior radiographs&#xD;
&#xD;
          3. Patients with a history of a previous subtotal medial or lateral meniscectomy&#xD;
&#xD;
          4. Patients with a history of septic arthritis in the affected joint&#xD;
&#xD;
          5. Patients with a history of a prior intra-articular knee fracture&#xD;
&#xD;
          6. Severe bleeding diathesis&#xD;
&#xD;
          7. Contraindication to bone marrow aspiration and/or biopsy&#xD;
&#xD;
          8. Active infection&#xD;
&#xD;
          9. Bone marrow failure&#xD;
&#xD;
         10. Cytopenia&#xD;
&#xD;
         11. Patients who have previously received radiotherapy to the pelvis&#xD;
&#xD;
         12. Patients who have been on chemotherapy from within a year of the date of informed&#xD;
&#xD;
         13. Patients with positive serological test for (HIV, HTLV1&amp;2, Hep A, B, C, syphilis)&#xD;
&#xD;
         14. Pregnancy or risk of pregnancy (this includes participants that are not willing to&#xD;
             practice active contraception for the duration of the study)&#xD;
&#xD;
         15. Patients with unforeseen conditions that are deemed unsafe or inappropriate for the&#xD;
             study (e.g. patients who are claustrophobic and cannot undergo an MRI) as per the&#xD;
             discretion of the principal investigator&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>YU TANG, Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Affiliated Hospital of Jiangsu University</affiliation>
  </overall_official>
  <verification_date>January 2018</verification_date>
  <study_first_submitted>January 20, 2017</study_first_submitted>
  <study_first_submitted_qc>January 20, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 23, 2017</study_first_posted>
  <last_update_submitted>January 27, 2018</last_update_submitted>
  <last_update_submitted_qc>January 27, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">January 30, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Affiliated Hospital of Jiangsu University</investigator_affiliation>
    <investigator_full_name>YU TANG</investigator_full_name>
    <investigator_title>Dr.</investigator_title>
  </responsible_party>
  <keyword>Osteoarthritis</keyword>
  <keyword>Stem Cell</keyword>
  <keyword>Knee</keyword>
  <keyword>Mesenchymal Stem Cell</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osteoarthritis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hyaluronic Acid</mesh_term>
  </intervention_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/NCT03028428
org study id: AHJiangsuU-FSK-MSC-OA
nct id: NCT03028428
lead sponsor: 
In this study, researchers want to determine the safety of MSCs that a patient can tolerate
      without causing side effects. Moreover researchers will also be looking at the function of
      the knee over time, which may give them some insight on the usefulness of MSCs as a treatment
      option.
Osteoarthritis (OA) is one of the most common forms of arthritis. It is a lasting condition
      in which the material that cushions the joints, called cartilage, breaks down. This causes
      the bones to rub against each other, causing inflammation, stiffness, pain and loss of joint
      movement. Currently, there are few effective treatments available for patients suffering from
      OA.

      Mesenchymal stem cells (MSCs) are cells that have the ability to self-regenerate, which means
      they have the ability to make copies of themselves and to turn into other kinds of cells
      (e.g. cartilage cells). Stem cell science shows much promise for the future treatment of
      osteoarthritis, but much of the research is still in the early stages. In this study,
      researchers want to determine the safety of MSCs that a patient can tolerate without causing
      side effects. Moreover researchers will also be looking at the function of the knee over
      time, which may give them some insight on the usefulness of MSCs as a treatment option.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: A Randomized, Double Blind, Phase-II Study Assessing the Safety and Efficacy of Intraarticular Ex-vivo Cultured Adult Allogeneic Mesenchymal Stem Cells in Patients with Osteoarthritis of Knee
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
masking description: Double blind
measure: adverse events
time frame: 1 Year
description: Number of participants with adverse events as measure of safety and tolerability
measure: radiographic evidence
time frame: 1 Year
description: Number of participants with a change in cartilage thickness of knee OA using MRI
measure: WOMAC assessment
time frame: 1 Year
description: Number of participants with a change in joint function from baseline WOMAC assessment
measure: VAS
time frame: 1 Year
description: Number of participants with a change in arthritis pain scores on the visual analogue scale
measure: SF-36
time frame: 1 Year
description: Number of participants with a change in SF-36
arm group label: Placenta Derived Mesenchymal Stem Cell
arm group type: Experimental
description: Placenta Derived Mesenchymal Stem Cell administered into the knee joint once
arm group label: sodium hyaluronate
arm group type: Active Comparator
description: Sodium hyaluronate administered into the knee joint once
intervention type: Biological
intervention name: Placenta Derived Mesenchymal Stem Cell
description: 1ml 1*10^7 Placenta Derived Mesenchymal Stem Cell administered into the knee joint once
arm group label: Placenta Derived Mesenchymal Stem Cell
other name: Mesenchymal Stromal Cells (MSCs)
intervention type: Drug
intervention name: Sodium Hyaluronate
description: Sodium hyaluronate administered into the knee joint once
arm group label: sodium hyaluronate
other name: hyaluronate
criteria: 
gender: All
minimum age: 40 Years
maximum age: 75 Years
healthy volunteers: No
last name: YU TANG, Dr.
role: Principal Investigator
affiliation: Affiliated Hospital of Jiangsu University
responsible party type: Principal Investigator
investigator affiliation: Affiliated Hospital of Jiangsu University
investigator full name: YU TANG
investigator title: Dr.
mesh term: Osteoarthritis
mesh term: Hyaluronic Acid