<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/NCT01709656</url>
  </required_header>
  <id_info>
    <org_study_id>[2012]2-31</org_study_id>
    <nct_id>NCT01709656</nct_id>
  </id_info>
  <brief_title>A Molecule Basic Study of Early Warning for New Pathogenic Risk of Ankylosing Spondylitis</brief_title>
  <official_title>A Molecule Basic Study of Early Warning for New Pathogenic Risk of Ankylosing Spondylitis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sun Yat-sen University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sun Yat-sen University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators will recruit active ankylosing spondylitis patients for injection treatment&#xD;
      of Human Mesenchymal Stem Cells (a prospective, open-label, masculine medicine&#xD;
      controlled(NSAIDs), clinical trial), and collect their Peripheral Blood Lymphocyte (PBMCs)&#xD;
      and sera before and after the treatment of 24 weeks to test the gene expression profiles and&#xD;
      study related pathogenesis of AS&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>March 2012</start_date>
  <completion_date type="Actual">December 2014</completion_date>
  <primary_completion_date type="Actual">December 2014</primary_completion_date>
  <phase>N/A</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>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>the proportion of patients which disease activity reaches ASAS(assessment in ankylosing Spondylitis)20 remission criteria</measure>
    <time_frame>24 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>BASDAI score comparing to baseline</measure>
    <time_frame>24 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>BASFI score comparing to baseline</measure>
    <time_frame>24 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">120</enrollment>
  <condition>Ankylosing Spondylitis</condition>
  <arm_group>
    <arm_group_label>MSC plus NSAID</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>human mesenchymal stem cells:1*10^4-6 cells /Kg , IV (in the vein) on day 1 of each 14-60 day cycle,1-6 times treatment, plus non-steroid anti-inflammatory drugs (NSAID: &quot;celecoxib&quot;, &quot;Celebrex®&quot; 0.2g Bid(twice a day),PO (Per Os).&#xD;
Duration of treatment:24 weeks for follow up. collect peripheral blood (PBMCs and serums)of those patients at baseline and every 4 weeks for basic study after they signed informed consent.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>NSAID</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>non-steroid anti-inflammatory drugs (NSAID: &quot;celecoxib&quot;, &quot;Celebrex®&quot; 0.2g Bid(twice a day),PO (Per Os);a total of 24 weeks for follow up;collect peripheral blood (PBMCs and serums)of those patients at baseline and every 4 weeks for basic study after they signed informed consent.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>MSC</intervention_name>
    <description>human mesenchymal stem cells,1*10^4-6 cells /Kg , IV (in the vein) on day 1 of each 14-60 day cycle,1-6 times treatment.&#xD;
a total of 24 weeks for follow up.</description>
    <arm_group_label>MSC plus NSAID</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>&quot;celecoxib&quot;, &quot;Celebrex®&quot;</intervention_name>
    <description>non-steroid anti-inflammatory drugs (NSAID):&quot;celecoxib&quot;, &quot;Celebrex®&quot; 0.2g Bid(twice a day),PO (Per Os);a total of 24 weeks for follow up</description>
    <arm_group_label>MSC plus NSAID</arm_group_label>
    <arm_group_label>NSAID</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Aged from 16-65 years, sign the Informed Consent&#xD;
&#xD;
          2. Fulfill 1984 modified NewYork classification criteria for AS&#xD;
&#xD;
          3. Have an active refractory disease defined by a score ≥40 on the Bath AS Disease&#xD;
             Activity Index (BASDAI) (0-100) despite optimal non-steroidal anti-inflammatory drug&#xD;
             (NSAID) treatment.&#xD;
&#xD;
          4. Commitment to contraceptive for woman&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Completely stiff spine&#xD;
&#xD;
          2. Received spinal or joint surgery within 2 months&#xD;
&#xD;
          3. Received anti-TNF therapy within 3 months&#xD;
&#xD;
          4. History of the listed diseases: heart failure, Multiple sclerosis, severe chronic&#xD;
             obstructive pulmonary disease, frequent infections, lymphoma or other cancers,&#xD;
             tuberculosis&#xD;
&#xD;
          5. Female of pregnancy or breast feeding&#xD;
&#xD;
          6. Hb≤ 9g/dl for male or Hb ≤ 8.5 g/dl for male, ALT/AST≥2folds of upper level normal&#xD;
             range, Creatine≥120mol/L(≤1.4mg/dl)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jieruo Gu, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Rheumatology , Third Affiliated Hospital of Sun Yat-sen University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Rheumatology, the Third Affiliated Hospital of Sun Yat-sen University</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>February 2015</verification_date>
  <study_first_submitted>October 10, 2012</study_first_submitted>
  <study_first_submitted_qc>October 16, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 18, 2012</study_first_posted>
  <last_update_submitted>February 10, 2015</last_update_submitted>
  <last_update_submitted_qc>February 10, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 11, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Sun Yat-sen University</investigator_affiliation>
    <investigator_full_name>Gu Jieruo</investigator_full_name>
    <investigator_title>Department of Rheumatology, Third Affiliated Hospital of Sun Yat-sen University</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Spondylitis</mesh_term>
    <mesh_term>Spondylarthritis</mesh_term>
    <mesh_term>Spondylitis, Ankylosing</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Celecoxib</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/NCT01709656
org study id: [2012]2-31
nct id: NCT01709656
lead sponsor: 
has dmc: Yes
The investigators will recruit active ankylosing spondylitis patients for injection treatment
      of Human Mesenchymal Stem Cells (a prospective, open-label, masculine medicine
      controlled(NSAIDs), clinical trial), and collect their Peripheral Blood Lymphocyte (PBMCs)
      and sera before and after the treatment of 24 weeks to test the gene expression profiles and
      study related pathogenesis of AS
allocation: Randomized
intervention model: Parallel Assignment
masking: None (Open Label)
measure: the proportion of patients which disease activity reaches ASAS(assessment in ankylosing Spondylitis)20 remission criteria
time frame: 24 weeks
measure: BASDAI score comparing to baseline
time frame: 24 weeks
measure: BASFI score comparing to baseline
time frame: 24 weeks
arm group label: MSC plus NSAID
arm group type: Experimental
description: human mesenchymal stem cells:1*10^4-6 cells /Kg , IV (in the vein) on day 1 of each 14-60 day cycle,1-6 times treatment, plus non-steroid anti-inflammatory drugs (NSAID: "celecoxib", "Celebrex®" 0.2g Bid(twice a day),PO (Per Os).
Duration of treatment:24 weeks for follow up. collect peripheral blood (PBMCs and serums)of those patients at baseline and every 4 weeks for basic study after they signed informed consent.
arm group label: NSAID
arm group type: Experimental
description: non-steroid anti-inflammatory drugs (NSAID: "celecoxib", "Celebrex®" 0.2g Bid(twice a day),PO (Per Os);a total of 24 weeks for follow up;collect peripheral blood (PBMCs and serums)of those patients at baseline and every 4 weeks for basic study after they signed informed consent.
intervention type: Biological
intervention name: MSC
description: human mesenchymal stem cells,1*10^4-6 cells /Kg , IV (in the vein) on day 1 of each 14-60 day cycle,1-6 times treatment.
a total of 24 weeks for follow up.
arm group label: MSC plus NSAID
intervention type: Drug
intervention name: "celecoxib", "Celebrex®"
description: non-steroid anti-inflammatory drugs (NSAID):"celecoxib", "Celebrex®" 0.2g Bid(twice a day),PO (Per Os);a total of 24 weeks for follow up
arm group label: MSC plus NSAID
arm group label: NSAID
criteria: 
gender: All
minimum age: 16 Years
maximum age: 65 Years
healthy volunteers: No
last name: Jieruo Gu, M.D.
role: Principal Investigator
affiliation: Department of Rheumatology , Third Affiliated Hospital of Sun Yat-sen University
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Sun Yat-sen University
investigator full name: Gu Jieruo
investigator title: Department of Rheumatology, Third Affiliated Hospital of Sun Yat-sen University
mesh term: Spondylitis
mesh term: Spondylarthritis
mesh term: Spondylitis, Ankylosing
mesh term: Celecoxib