<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/NCT03007576</url>
  </required_header>
  <id_info>
    <org_study_id>EMOCT01</org_study_id>
    <nct_id>NCT03007576</nct_id>
  </id_info>
  <brief_title>Treatment of Knee Osteoarthritis With Autologous Mesenchymal Stromal Cell Product (RegStem)</brief_title>
  <official_title>Phase I Clinical Trial - Treatment of Knee Osteoarthritis With Autologous Mesenchymal Stromal Cell Product (RegStem)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>EMO Biomedicine Corporation</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Far Eastern Memorial Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>EMO Biomedicine Corporation</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>
      Osteoarthritis (OA) is a common and incurable disease for the elderly in Taiwan, so it is an&#xD;
      important mission to develop a new treatment for OA. Recently, cellular therapy is a new and&#xD;
      popular medical treatment around the world, one of them is &quot;Mesenchymal Stromal Cells&#xD;
      (MSCs)&quot;. MSCs are found in many tissues of human body and play an important role for&#xD;
      repairing, regeneration, anti-inflammatory and chondrogenesis. So, MSC product, RegStem, for&#xD;
      osteoarthritis treatment becomes a developing target for new generation drugs.&#xD;
&#xD;
      This study is to isolate and expand MSCs(RegStem) from infrapatellar fat pad of subject. When&#xD;
      the number of MSCs expands to 1×10^8, cell will be cryopreserved in the liquid nitrogen tank&#xD;
      until all release tests passed. On the distribution day, cell will be thawed and injected&#xD;
      into joint cavity of patient (5×10^7). Subjects will be monitored after MSC product infusion&#xD;
      of seven days, one month, six months and one year. The monitoring items include the changes&#xD;
      of knee (by appearance, X-ray and MRI of knee) and pain improvement (by questionnaire).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 1, 2017</start_date>
  <completion_date type="Actual">August 31, 2019</completion_date>
  <primary_completion_date type="Actual">August 31, 2019</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>Safety of RegStem by incidence of adverse events and changes in physical examinations, vital signs and the results of clinical lab tests.</measure>
    <time_frame>48 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Clinical assessment of International Knee Documentation Committee (IKDC) score</measure>
    <time_frame>48 weeks</time_frame>
    <description>Assess symptoms of knee, sport activity and function of knee</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Clinical assessment of Knee injury and Osteoarthritis Outcome Score (KOOS)</measure>
    <time_frame>48 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical assessment of visual analogue scale (VAS)</measure>
    <time_frame>48 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical assessment of knee X-ray</measure>
    <time_frame>48 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical assessment of knee MRI</measure>
    <time_frame>48 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">12</enrollment>
  <condition>Osteoarthritis,Knee</condition>
  <arm_group>
    <arm_group_label>RegStem</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Autologous MSC, 5×10^7 cells, one injection</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>RegStem</intervention_name>
    <description>RegStem, 1.5 ml, one injection</description>
    <arm_group_label>RegStem</arm_group_label>
    <other_name>MSC</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Subjects who understand and sign the informed consent form for this study&#xD;
&#xD;
          2. Grade 2~3 osteoarthritis according to the Kellgren-Lawrence grading scale with&#xD;
             one-month X-ray&#xD;
&#xD;
          3. Age is 50~75 years old&#xD;
&#xD;
          4. Postmenopausal women&#xD;
&#xD;
          5. VAS scores in 50 to 90 mm&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Abnormal of liver and kidney: GOT and GPT &gt; 100 IU/L, BUN &gt;22 mg/dl and creatinine &gt;&#xD;
             1.2 mg/dl.&#xD;
&#xD;
          2. Positive serology for HIV, HTLV-1/2 and syphilis&#xD;
&#xD;
          3. Women who are pregnant or breast feeding&#xD;
&#xD;
          4. Serious pre-existing medical conditions: coagulation disorders, cardiovascular&#xD;
             diseases (arrhythmias, myocardial infarction and surgery), renal diseases (chronic&#xD;
             renal failure), liver diseases (cirrhosis), diabetes mellitus type I, cancer history.&#xD;
&#xD;
          5. Other joint diseases: knee deformity (knee varus greater than 10 degree or valgus&#xD;
             greater than 20 degree), rheumatic arthritis, gouty arthritis, septic arthritis,&#xD;
             serious meniscal tear, other autoimmune arthritis.&#xD;
&#xD;
          6. Skin inflammatory of knee&#xD;
&#xD;
          7. Knee pain caused by referred pain from spine disease or hip joint disease. Knee pain&#xD;
             combined with pain from spine disease or hip disease.&#xD;
&#xD;
          8. Immunosuppressive state&#xD;
&#xD;
          9. Subjects who were injected with hyaluronic acid and PRP in the past 6 months&#xD;
&#xD;
         10. Body mass index (BMI) greater than 30&#xD;
&#xD;
         11. Have a history of allergic reaction of any medication&#xD;
&#xD;
         12. Participation in another clinical trial or treatment within 3 months&#xD;
&#xD;
         13. Other pathologic conditions or circumstances that difficult participation in this&#xD;
             study according to PI's evaluations&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Far Eastern Memorial Hospital</name>
      <address>
        <city>Taipei</city>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>November 2019</verification_date>
  <study_first_submitted>December 21, 2016</study_first_submitted>
  <study_first_submitted_qc>December 29, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 2, 2017</study_first_posted>
  <last_update_submitted>November 10, 2019</last_update_submitted>
  <last_update_submitted_qc>November 10, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">November 13, 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>Osteoarthritis</mesh_term>
    <mesh_term>Osteoarthritis, Knee</mesh_term>
  </condition_browse>
  <pending_results>
    <submitted>August 14, 2022</submitted>
    <returned>July 12, 2023</returned>
  </pending_results>
  <!-- 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/NCT03007576
org study id: EMOCT01
nct id: NCT03007576
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Osteoarthritis (OA) is a common and incurable disease for the elderly in Taiwan, so it is an
      important mission to develop a new treatment for OA. Recently, cellular therapy is a new and
      popular medical treatment around the world, one of them is "Mesenchymal Stromal Cells
      (MSCs)". MSCs are found in many tissues of human body and play an important role for
      repairing, regeneration, anti-inflammatory and chondrogenesis. So, MSC product, RegStem, for
      osteoarthritis treatment becomes a developing target for new generation drugs.

      This study is to isolate and expand MSCs(RegStem) from infrapatellar fat pad of subject. When
      the number of MSCs expands to 1×10^8, cell will be cryopreserved in the liquid nitrogen tank
      until all release tests passed. On the distribution day, cell will be thawed and injected
      into joint cavity of patient (5×10^7). Subjects will be monitored after MSC product infusion
      of seven days, one month, six months and one year. The monitoring items include the changes
      of knee (by appearance, X-ray and MRI of knee) and pain improvement (by questionnaire).
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Safety of RegStem by incidence of adverse events and changes in physical examinations, vital signs and the results of clinical lab tests.
time frame: 48 weeks
measure: Clinical assessment of International Knee Documentation Committee (IKDC) score
time frame: 48 weeks
description: Assess symptoms of knee, sport activity and function of knee
measure: Clinical assessment of Knee injury and Osteoarthritis Outcome Score (KOOS)
time frame: 48 weeks
measure: Clinical assessment of visual analogue scale (VAS)
time frame: 48 weeks
measure: Clinical assessment of knee X-ray
time frame: 48 weeks
measure: Clinical assessment of knee MRI
time frame: 48 weeks
arm group label: RegStem
arm group type: Experimental
description: Autologous MSC, 5×10^7 cells, one injection
intervention type: Biological
intervention name: RegStem
description: RegStem, 1.5 ml, one injection
arm group label: RegStem
other name: MSC
criteria: 
gender: All
minimum age: 50 Years
maximum age: 75 Years
healthy volunteers: No
facility: 
country: Taiwan
responsible party type: Sponsor
mesh term: Osteoarthritis
mesh term: Osteoarthritis, Knee
submitted: August 14, 2022
returned: July 12, 2023