<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/NCT01677013</url>
  </required_header>
  <id_info>
    <org_study_id>PUACH-721002</org_study_id>
    <nct_id>NCT01677013</nct_id>
  </id_info>
  <brief_title>Autologous Bone Marrow Mononuclear Cell Transplantation in Treating Type 2 Diabetes Mellitus</brief_title>
  <official_title>Efficacy of Autologous Bone Marrow Mononuclear Cell Transplantation in Treating Selective Type 2 Diabetes Mellitus</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Peking University Aerospace Centre Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Peking University Aerospace Centre Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study is aimed to evaluate the safety and efficiency of autologous bone marrow&#xD;
      mononuclear cell transplantation in treating selective patients with type 2 Diabetes&#xD;
      Mellitus. We hypothesized that autologous bone marrow stem cell transplantation would promote&#xD;
      β-cells regeneration by directly differentiated from the transplanted BMMCs or stimulate&#xD;
      local stem cells regeneration and thus decrease or eliminate the need of exogenous insulin&#xD;
      and improve β-cells function.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      To study the safety and efficacy of bone marrow mononuclear cell transplantation in type 2&#xD;
      diabetics. According to the intervention and baseline characteristics, patients are divided&#xD;
      into 4 arms.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>May 2011</start_date>
  <completion_date type="Actual">July 2017</completion_date>
  <primary_completion_date type="Actual">May 2015</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>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>C-peptide</measure>
    <time_frame>1 year</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>reduction of medication</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>HbA1c</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>adverse event</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">1026</enrollment>
  <condition>Type 2 Diabetes Mellitus</condition>
  <arm_group>
    <arm_group_label>Oral medication treatment</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>type 2 diabetics with only oral medications</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Oral medication plus BMMCT</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Collect mononuclear cells from bone marrow aspiration, administer to pancreas via selective catheterization to splenic artery.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Oral medication plus insulin treatment</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Type 2 diabetics who need insulin therapy with oral medications</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Oral medication plus insulin plus BMMCT</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Collect mononuclear cells from bone marrow aspiration, administer to pancreas via selective catheterization to splenic artery.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>BMMCT</intervention_name>
    <description>Bone marrow mononuclear cell transplantation via selective catheterization</description>
    <arm_group_label>Oral medication plus BMMCT</arm_group_label>
    <arm_group_label>Oral medication plus insulin plus BMMCT</arm_group_label>
    <other_name>Bone marrow mononuclear cell transplantation</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Type 2 diabetes mellitus&#xD;
&#xD;
          -  age 30-70&#xD;
&#xD;
          -  stable doses of medication for at least 3 months&#xD;
&#xD;
          -  BMI &lt;35 and &gt;18.5&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  secondary cause for hyperglycemia&#xD;
&#xD;
          -  pregnancy or nursing&#xD;
&#xD;
          -  positive autoimmune antibody of diabetes&#xD;
&#xD;
          -  severe complication or concurrent diseases&#xD;
&#xD;
          -  active infection or febrile illness&#xD;
&#xD;
          -  allergy to iodine&#xD;
&#xD;
          -  history or signs of aortic aneurysm&#xD;
&#xD;
          -  history or active pancreatic diseases&#xD;
&#xD;
          -  known substance abuse or alcoholism or heavy smoking&#xD;
&#xD;
          -  not suitable for other conditions upon investigators' expertise&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yizhong Wang, M.D., Ph.D.</last_name>
    <role>Study Chair</role>
    <affiliation>Division of Hematology and Endocrinology, Peking University Aerospace Centre Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Yuanjie Mao, M.D., Ph.D.</last_name>
    <role>Study Director</role>
    <affiliation>Department of Biochemisty, National Cerebral and Cardiovascular Center; Department of Cardiology, China-Japan Friendship Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Lei Lei, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Division of Hematology and Endocrinology, Peking University Aerospace Centre Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Danping Meng, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Division of Hematology and Endocrinology, Peking University Aerospace Centre Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Xiyang Zhang, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Division of Hematology and Endocrinology, Peking University Aerospace Centre Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Xiaolin Jia, M.D.</last_name>
    <role>Study Director</role>
    <affiliation>Division of Hematology and Endocrinology, Peking University Aerospace Centre Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Qiuming Jiang, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Division of Hematology and Endocrinology, Peking University Aerospace Centre Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Yufang Li, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Division of Hematology and Endocrinology, Peking University Aerospace Centre Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Song Dong, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Division of Hematology and Endocrinology, Peking University Aerospace Centre Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Liyan Yang, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Division of Hematology and Endocrinology, Peking University Aerospace Centre Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Hong Wang, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Division of Hematology and Endocrinology, Peking University Aerospace Centre Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Mingchao Ding, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Division of Hematology and Endocrinology, Peking University Aerospace Centre Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Liqin Cui, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Division of Hematology and Endocrinology, Peking University Aerospace Centre Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Bin Wang, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Division of Hematology and Endocrinology, Peking University Aerospace Centre Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Xin Lin, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Division of Hematology and Endocrinology, Peking University Aerospace Centre Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Han Shi, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Division of Hematology and Endocrinology, Peking University Aerospace Centre Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Division of Hematology and Endocrinology, Peking University Aerospace Centre Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100049</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>August 29, 2012</study_first_submitted>
  <study_first_submitted_qc>August 29, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 31, 2012</study_first_posted>
  <last_update_submitted>September 30, 2017</last_update_submitted>
  <last_update_submitted_qc>September 30, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 3, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Peking University Aerospace Centre Hospital</investigator_affiliation>
    <investigator_full_name>Lei Lei, MD</investigator_full_name>
    <investigator_title>Endocrinologist</investigator_title>
  </responsible_party>
  <keyword>Type 2; diabetes mellitus; stem cell; safety; efficacy</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/NCT01677013
org study id: PUACH-721002
nct id: NCT01677013
lead sponsor: 
has dmc: Yes
The study is aimed to evaluate the safety and efficiency of autologous bone marrow
      mononuclear cell transplantation in treating selective patients with type 2 Diabetes
      Mellitus. We hypothesized that autologous bone marrow stem cell transplantation would promote
      β-cells regeneration by directly differentiated from the transplanted BMMCs or stimulate
      local stem cells regeneration and thus decrease or eliminate the need of exogenous insulin
      and improve β-cells function.
To study the safety and efficacy of bone marrow mononuclear cell transplantation in type 2
      diabetics. According to the intervention and baseline characteristics, patients are divided
      into 4 arms.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: C-peptide
time frame: 1 year
measure: reduction of medication
time frame: 1 year
measure: HbA1c
time frame: 1 year
measure: adverse event
time frame: 1 year
arm group label: Oral medication treatment
arm group type: No Intervention
description: type 2 diabetics with only oral medications
arm group label: Oral medication plus BMMCT
arm group type: Experimental
description: Collect mononuclear cells from bone marrow aspiration, administer to pancreas via selective catheterization to splenic artery.
arm group label: Oral medication plus insulin treatment
arm group type: No Intervention
description: Type 2 diabetics who need insulin therapy with oral medications
arm group label: Oral medication plus insulin plus BMMCT
arm group type: Experimental
description: Collect mononuclear cells from bone marrow aspiration, administer to pancreas via selective catheterization to splenic artery.
intervention type: Other
intervention name: BMMCT
description: Bone marrow mononuclear cell transplantation via selective catheterization
arm group label: Oral medication plus BMMCT
arm group label: Oral medication plus insulin plus BMMCT
other name: Bone marrow mononuclear cell transplantation
criteria: 
gender: All
minimum age: 30 Years
maximum age: 70 Years
healthy volunteers: No
last name: Yizhong Wang, M.D., Ph.D.
role: Study Chair
affiliation: Division of Hematology and Endocrinology, Peking University Aerospace Centre Hospital
last name: Yuanjie Mao, M.D., Ph.D.
role: Study Director
affiliation: Department of Biochemisty, National Cerebral and Cardiovascular Center; Department of Cardiology, China-Japan Friendship Hospital
last name: Lei Lei, M.D.
role: Principal Investigator
affiliation: Division of Hematology and Endocrinology, Peking University Aerospace Centre Hospital
last name: Danping Meng, M.D.
role: Principal Investigator
affiliation: Division of Hematology and Endocrinology, Peking University Aerospace Centre Hospital
last name: Xiyang Zhang, M.D.
role: Principal Investigator
affiliation: Division of Hematology and Endocrinology, Peking University Aerospace Centre Hospital
last name: Xiaolin Jia, M.D.
role: Study Director
affiliation: Division of Hematology and Endocrinology, Peking University Aerospace Centre Hospital
last name: Qiuming Jiang, M.D.
role: Principal Investigator
affiliation: Division of Hematology and Endocrinology, Peking University Aerospace Centre Hospital
last name: Yufang Li, M.D.
role: Principal Investigator
affiliation: Division of Hematology and Endocrinology, Peking University Aerospace Centre Hospital
last name: Song Dong, M.D.
role: Principal Investigator
affiliation: Division of Hematology and Endocrinology, Peking University Aerospace Centre Hospital
last name: Liyan Yang, M.D.
role: Principal Investigator
affiliation: Division of Hematology and Endocrinology, Peking University Aerospace Centre Hospital
last name: Hong Wang, M.D.
role: Principal Investigator
affiliation: Division of Hematology and Endocrinology, Peking University Aerospace Centre Hospital
last name: Mingchao Ding, M.D.
role: Principal Investigator
affiliation: Division of Hematology and Endocrinology, Peking University Aerospace Centre Hospital
last name: Liqin Cui, M.D.
role: Principal Investigator
affiliation: Division of Hematology and Endocrinology, Peking University Aerospace Centre Hospital
last name: Bin Wang, M.D.
role: Principal Investigator
affiliation: Division of Hematology and Endocrinology, Peking University Aerospace Centre Hospital
last name: Xin Lin, M.D.
role: Principal Investigator
affiliation: Division of Hematology and Endocrinology, Peking University Aerospace Centre Hospital
last name: Han Shi, M.D.
role: Principal Investigator
affiliation: Division of Hematology and Endocrinology, Peking University Aerospace Centre Hospital
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Peking University Aerospace Centre Hospital
investigator full name: Lei Lei, MD
investigator title: Endocrinologist
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2