<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/NCT04441658</url>
  </required_header>
  <id_info>
    <org_study_id>DFSC-2020(CR)-02</org_study_id>
    <nct_id>NCT04441658</nct_id>
  </id_info>
  <brief_title>Efficacy and Safety of Umbilical Cord Mesenchymal Stem Cells Transplantation in Patients With Type 2 Diabetes Mellitus</brief_title>
  <official_title>Efficacy and Safety of Umbilical Cord Mesenchymal Stem Cells Transplantation in Patients With Type 2 Diabetes Mellitus</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shanghai East Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Shanghai East Hospital</source>
  <oversight_info>
    <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 is a 24-week single-center, randomized, double-blind, placebo-controlled trial.&#xD;
      The trial includes a 3-week early screening and lifestyle education period, 6-week treatment&#xD;
      period, and 18-week follow-up period. Chinese type 2 diabetic subjects receiving traditional&#xD;
      hypoglycemic treatment were randomly assigned to umbilical cord mesenchymal stem cell or&#xD;
      placebo infusion therapy to observe the efficacy and safety of umbilical cord mesenchymal&#xD;
      stem cell infusion therapy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is a 24-week single-center, randomized, double-blind, placebo-controlled trial.&#xD;
      The trial includes a 3-week early screening and lifestyle education period, 6-week treatment&#xD;
      period, and 18-week follow-up period. Chinese type 2 diabetic subjects receiving traditional&#xD;
      hypoglycemic treatment（including insulin） were randomly assigned to umbilical cord&#xD;
      mesenchymal stem cell or placebo infusion therapy to observe the efficacy and safety of&#xD;
      umbilical cord mesenchymal stem cell infusion therapy.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">April 10, 2020</start_date>
  <completion_date type="Anticipated">December 2022</completion_date>
  <primary_completion_date type="Anticipated">July 2022</primary_completion_date>
  <phase>Phase 1/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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The changes in HbA1C level</measure>
    <time_frame>24 weeks after treatment</time_frame>
    <description>The changes in HbA1C level after transplantation</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Reduction of insulin requirement</measure>
    <time_frame>24 weeks after treatment</time_frame>
    <description>Reduction of insulin requirement after transplantation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The changes in blood glucose level</measure>
    <time_frame>24 weeks after treatment</time_frame>
    <description>The changes in blood glucose level after transplantation</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Type 2 Diabetes</condition>
  <condition>Mesenchymal Stem Cells</condition>
  <arm_group>
    <arm_group_label>experimental group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The volunteers of the experimental group will be given peripheral intravenously a dose of 0.75*10^6/ kg human umbilical cord mesenchymal stem cells at 0,1,5,6 week.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>The control group will be given the same dose of saline containing human albumin.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Umbilical Cord Mesenchymal Stem Cells</intervention_name>
    <description>human umbilical cord mesenchymal stem cells were peripheral intravenous infused to experimental group</description>
    <arm_group_label>experimental group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>saline</intervention_name>
    <description>saline containing human albumin will be infused to the control group</description>
    <arm_group_label>control group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Type 2 diabetes；&#xD;
&#xD;
          2. The course of diabetes is 5-15 years;&#xD;
&#xD;
          3. 20kg/m2≤body mass index (BMI)≤30 kg /m2；&#xD;
&#xD;
          4. 7.5% ≤HbA1c≤10%；&#xD;
&#xD;
          5. Insulin dose and other oral antidiabetic drugs doses should be stable over the 3&#xD;
             months prior to randomization.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Heavy allergic constitution or an allergy to any component used in cell culture.&#xD;
&#xD;
          2. Being treated with drug (Glucocorticoids，Tricyclic Antidepressive Agents,etc.) affect&#xD;
             the metabolism of glucose in the past 1 month;&#xD;
&#xD;
          3. other causes of diabetes;&#xD;
&#xD;
          4. All kinds of acute complications such as diabetic ketoacidosis and&#xD;
             non-ketohyperosmotic syndrome were screened in the past 6 months;&#xD;
&#xD;
          5. Having evidence of ongoing or frequent/severe hypoglycemia in the past 6 months;&#xD;
&#xD;
          6. Severe cardiovascular and cerebral events：occurrence of heart failure NYHA&#xD;
             Classification III or IV, myocardial infarction, cerebral infarction, cerebral&#xD;
             hemorrhage within 6 months before the observation period;&#xD;
&#xD;
          7. Patients with abnormal liver and kidney function: AST and ALT exceeding 2.5 times of&#xD;
             the normal upper limit, and serum creatinine exceeding 1.5 mg/dl for men, exceeding&#xD;
             1.4 mg/dl for women;&#xD;
&#xD;
          8. Positive results of HbsAg、Anti-HCV、HIV or syphilis;&#xD;
&#xD;
          9. Patients suffering from other serious systemic diseases (such as malignancy, central&#xD;
             nervous system,cardiovascular system, blood system, digestive system,endocrine&#xD;
             system,respiratory system, genitourinary system, immune system and);&#xD;
&#xD;
         10. Ongoing pregnancy or absence of effective contraception in women with childbearing&#xD;
             potential;&#xD;
&#xD;
         11. Patients who had received other stem cell therapy before screening.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>wang congrong, doctor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Shanghai East Hospital, China</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>wang congrong, doctor</last_name>
    <phone>+86-021-38804518</phone>
    <email>wcr601@163.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>liu zhongmin, doctor</last_name>
    <phone>+86-021-38804518</phone>
    <email>liu.zhongmin@tongji.edu.cn</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Shanghai East Hospital, Shanghai Tongji University</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200120</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>wang congrong, doctor</last_name>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 19, 2020</study_first_submitted>
  <study_first_submitted_qc>June 19, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 22, 2020</study_first_posted>
  <last_update_submitted>June 19, 2020</last_update_submitted>
  <last_update_submitted_qc>June 19, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 22, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Umbilical Cord Mesenchymal Stem Cells</keyword>
  <keyword>Type 2 Diabetes</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 2</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/NCT04441658
org study id: DFSC-2020(CR)-02
nct id: NCT04441658
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
This study is a 24-week single-center, randomized, double-blind, placebo-controlled trial.
      The trial includes a 3-week early screening and lifestyle education period, 6-week treatment
      period, and 18-week follow-up period. Chinese type 2 diabetic subjects receiving traditional
      hypoglycemic treatment were randomly assigned to umbilical cord mesenchymal stem cell or
      placebo infusion therapy to observe the efficacy and safety of umbilical cord mesenchymal
      stem cell infusion therapy.
This study is a 24-week single-center, randomized, double-blind, placebo-controlled trial.
      The trial includes a 3-week early screening and lifestyle education period, 6-week treatment
      period, and 18-week follow-up period. Chinese type 2 diabetic subjects receiving traditional
      hypoglycemic treatment（including insulin） were randomly assigned to umbilical cord
      mesenchymal stem cell or placebo infusion therapy to observe the efficacy and safety of
      umbilical cord mesenchymal stem cell infusion therapy.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: The changes in HbA1C level
time frame: 24 weeks after treatment
description: The changes in HbA1C level after transplantation
measure: Reduction of insulin requirement
time frame: 24 weeks after treatment
description: Reduction of insulin requirement after transplantation
measure: The changes in blood glucose level
time frame: 24 weeks after treatment
description: The changes in blood glucose level after transplantation
arm group label: experimental group
arm group type: Experimental
description: The volunteers of the experimental group will be given peripheral intravenously a dose of 0.75*10^6/ kg human umbilical cord mesenchymal stem cells at 0,1,5,6 week.
arm group label: control group
arm group type: Placebo Comparator
description: The control group will be given the same dose of saline containing human albumin.
intervention type: Biological
intervention name: Umbilical Cord Mesenchymal Stem Cells
description: human umbilical cord mesenchymal stem cells were peripheral intravenous infused to experimental group
arm group label: experimental group
intervention type: Biological
intervention name: saline
description: saline containing human albumin will be infused to the control group
arm group label: control group
criteria: 
gender: All
minimum age: 30 Years
maximum age: 75 Years
healthy volunteers: No
last name: wang congrong, doctor
role: Principal Investigator
affiliation: Shanghai East Hospital, China
last name: wang congrong, doctor
phone: +86-021-38804518
email: wcr601@163.com
last name: liu zhongmin, doctor
phone: +86-021-38804518
email: liu.zhongmin@tongji.edu.cn
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Sponsor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2