<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/NCT03798028</url>
  </required_header>
  <id_info>
    <org_study_id>2014ZX09508002</org_study_id>
    <nct_id>NCT03798028</nct_id>
  </id_info>
  <brief_title>The Safety and Effects of Mesenchymal Stem Cell (MSCs) in the Treatment of Rheumatoid Arthritis</brief_title>
  <official_title>The Effects and Safety of Mesenchymal Stem Cells in the Treatment of Moderate/Severe Rheumatoid Arthritis， a Multicenter Randomized Controlled Clinical Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Xijing Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Changhai Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Southwest Hospital, China</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Xijing Hospital</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>
      This study evaluates the safety and therapeutic effects of single-dose human umbilical cord&#xD;
      blood mesenchymal stem cells (UC-MSCs) on the adult patients with moderate/severe Rheumatoid&#xD;
      Arthritis accompany with anemia or/and Interstitial pulmonary disease. Half of participants&#xD;
      will receive UC-MSCs and keep the present medication,while the other half will receive a&#xD;
      placebo and keep the present medication.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">December 26, 2017</start_date>
  <completion_date type="Anticipated">June 30, 2020</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2019</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Improvement rate of blood routine hemoglobin (HGB) compared to baseline.</measure>
    <time_frame>24 weeks</time_frame>
    <description>The HGB increases by 10g compared to the baseline is considered improvement.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Improvement rate of forced vital capacity (FVC) and/or carbon monoxide diffusing capacity (DLCO) compared to baseline.</measure>
    <time_frame>24 weeks</time_frame>
    <description>FVC increases by 0.5% and DLCO increases by 10% compared to baseline are considered improvement.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The remission rates of American College of Rheumatology (ACR) 20, ACR 50 and ACR 70.</measure>
    <time_frame>12 weeks and 24 weeks</time_frame>
    <description>The patients achieves 20%, 50%, or 70% remission according to American College of Rheumatology (ACR) criteria.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>White blood cell count and platelet count improved compared to the baseline.</measure>
    <time_frame>12 weeks and 24 weeks</time_frame>
    <description>White blood cell count increases to the 3.5×10^9/L and platelet count increases to 80×10^ 9.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Improvement rate of blood routine hemoglobin (HGB) compared to baseline.</measure>
    <time_frame>12 weeks</time_frame>
    <description>The HGB increases by 10 g compared to the baseline is considered improvement.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Improvement rate of forced vital capacity (FVC) and/or carbon monoxide</measure>
    <time_frame>12 weeks</time_frame>
    <description>FVC increases by 0.5% and DLCO increases by 10% compared to baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Image improvement of lung on high resolution CT.</measure>
    <time_frame>24 weeks</time_frame>
    <description>The area change of image of lung.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Improvement of 6-minute walking distance compared to baseline.</measure>
    <time_frame>12 weeks and 24 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">250</enrollment>
  <condition>Rheumatoid Arthritis</condition>
  <arm_group>
    <arm_group_label>UC-MSCs treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>the participants will receive the single-dose UC-MSCs (1×10^6 cells/kg ) in combined with the present treatment.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>no UC-MSCs treatment</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>the participants will receive the placebo in combined with the present treatment.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>UC-MSCs</intervention_name>
    <description>The UC-MSCs will be administrated by intravenous injection at the dose of 1×10^6 cells/kg.</description>
    <arm_group_label>UC-MSCs treatment</arm_group_label>
    <other_name>placebo</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Fulfill 2010 ACR/ the European League Against Rheumatism (EULAR) classification&#xD;
             criteria or the 1987 ACR classification criteria.&#xD;
&#xD;
          2. Age limits:18 to 70 years old.&#xD;
&#xD;
          3. Freely given informed consent.&#xD;
&#xD;
          4. Disease Activity Score (DAS) 28≥3.2或 Simple Disease Activity Index (SDAI)&gt;11.0或&#xD;
             Clinical Disease Activity Index (CDAI) &gt;10.0.&#xD;
&#xD;
          5. Hemoglobin &lt; 90 g/L and/or interstitial lung disease shown in high resolution CT.&#xD;
&#xD;
          6. Poor response to current treatment. The current treatment refers to receive the&#xD;
             medicines (including Leflunomide, Methotrexate, Sulphasalazine, Hydroxychloroquine,&#xD;
             Cyclosporine A,and Tacrolimus, alone or in combination ) for 3 months, and maintain&#xD;
             the stable-dose of drugs for at least 1 month.&#xD;
&#xD;
          7. More than 3 months and a stable dose for at least 1 month are required if&#xD;
             glucocorticoid is used. The dose of glucocorticoid is less than or equal to10mg/ day&#xD;
             of prednisone.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Participants who received glucocorticoid therapy by intra-articular injection within 1&#xD;
             week.&#xD;
&#xD;
          2. Glucocorticoid that participants received is more than 10 mg/day of prednisone within&#xD;
             1 months.&#xD;
&#xD;
          3. Complication with other connective tissue disease (except for Sjogren syndrome) .&#xD;
&#xD;
          4. Participants with chronic and acute infection (bacteria, virus and parasite,etc.).&#xD;
&#xD;
          5. Participants with acute and chronic tuberculosis infection.&#xD;
&#xD;
          6. Malignant tumors or participants with a family history of malignant tumors.&#xD;
&#xD;
          7. Participants have a family history of allergic conditions.&#xD;
&#xD;
          8. Participants infected by Hepatitis B Virus(HBV), Hepatitis C Virus (HCV) and Human&#xD;
             Immunodeficiency Virus （HIV）.&#xD;
&#xD;
          9. Participants suffer from central nervous system demyelinating disease or multiple&#xD;
             sclerosis (MS) currently or in the past.&#xD;
&#xD;
         10. Participants received live vaccines with 3 months.&#xD;
&#xD;
         11. Drug abuse and alcoholism.&#xD;
&#xD;
         12. Participants with severe mental or neurological disorders that affect informed consent&#xD;
             and/or the presentation or observer of adverse events.&#xD;
&#xD;
         13. Participants with pregnant or in breast-feeding, and patients who has a pregnancy plan&#xD;
             within 1 year.&#xD;
&#xD;
         14. Participants received stem cell therapy in the past.&#xD;
&#xD;
         15. Participants received any biological agents within 3 months.&#xD;
&#xD;
         16. Anemia (such as anemia with dysplasia) and interstitial lung disease for other&#xD;
             reasons.&#xD;
&#xD;
         17. Participants with cardiovascular and cerebrovascular damage, such as thrombosis.&#xD;
&#xD;
         18. Participants taking drugs that affect the test for blood and lung.&#xD;
&#xD;
         19. Participants taking any traditional Chinese medicine.&#xD;
&#xD;
         20. Participants taking immune modulators such as Transfer Factor, Thymosin and&#xD;
             Intravenous Immunoglobulin (IVIG), and so on.&#xD;
&#xD;
         21. Other cases that participants are considered by investigator that they did not meet&#xD;
             the requirements for enrollment.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Ping Zhu, Doctor</last_name>
    <phone>86-29-84773951</phone>
    <email>zhuping@fmmu.edu.cn</email>
  </overall_contact>
  <location>
    <facility>
      <name>Xijing Hospital</name>
      <address>
        <city>Xi'an</city>
        <state>Shaanxi</state>
        <zip>710032</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ping Zhu</last_name>
      <phone>862984773951</phone>
      <phone_ext>862984773951</phone_ext>
      <email>zhuping@fmmu.edu.cn</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>January 7, 2019</study_first_submitted>
  <study_first_submitted_qc>January 7, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 9, 2019</study_first_posted>
  <last_update_submitted>January 7, 2019</last_update_submitted>
  <last_update_submitted_qc>January 7, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 9, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>anemia</keyword>
  <keyword>Interstitial pulmonary disease</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Arthritis</mesh_term>
    <mesh_term>Arthritis, Rheumatoid</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/NCT03798028
org study id: 2014ZX09508002
nct id: NCT03798028
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study evaluates the safety and therapeutic effects of single-dose human umbilical cord
      blood mesenchymal stem cells (UC-MSCs) on the adult patients with moderate/severe Rheumatoid
      Arthritis accompany with anemia or/and Interstitial pulmonary disease. Half of participants
      will receive UC-MSCs and keep the present medication,while the other half will receive a
      placebo and keep the present medication.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Improvement rate of blood routine hemoglobin (HGB) compared to baseline.
time frame: 24 weeks
description: The HGB increases by 10g compared to the baseline is considered improvement.
measure: Improvement rate of forced vital capacity (FVC) and/or carbon monoxide diffusing capacity (DLCO) compared to baseline.
time frame: 24 weeks
description: FVC increases by 0.5% and DLCO increases by 10% compared to baseline are considered improvement.
measure: The remission rates of American College of Rheumatology (ACR) 20, ACR 50 and ACR 70.
time frame: 12 weeks and 24 weeks
description: The patients achieves 20%, 50%, or 70% remission according to American College of Rheumatology (ACR) criteria.
measure: White blood cell count and platelet count improved compared to the baseline.
time frame: 12 weeks and 24 weeks
description: White blood cell count increases to the 3.5×10^9/L and platelet count increases to 80×10^ 9.
measure: Improvement rate of blood routine hemoglobin (HGB) compared to baseline.
time frame: 12 weeks
description: The HGB increases by 10 g compared to the baseline is considered improvement.
measure: Improvement rate of forced vital capacity (FVC) and/or carbon monoxide
time frame: 12 weeks
description: FVC increases by 0.5% and DLCO increases by 10% compared to baseline
measure: Image improvement of lung on high resolution CT.
time frame: 24 weeks
description: The area change of image of lung.
measure: Improvement of 6-minute walking distance compared to baseline.
time frame: 12 weeks and 24 weeks
arm group label: UC-MSCs treatment
arm group type: Experimental
description: the participants will receive the single-dose UC-MSCs (1×10^6 cells/kg ) in combined with the present treatment.
arm group label: no UC-MSCs treatment
arm group type: No Intervention
description: the participants will receive the placebo in combined with the present treatment.
intervention type: Biological
intervention name: UC-MSCs
description: The UC-MSCs will be administrated by intravenous injection at the dose of 1×10^6 cells/kg.
arm group label: UC-MSCs treatment
other name: placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Ping Zhu, Doctor
phone: 86-29-84773951
email: zhuping@fmmu.edu.cn
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Sponsor
mesh term: Arthritis
mesh term: Arthritis, Rheumatoid