<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/NCT01694173</url>
  </required_header>
  <id_info>
    <org_study_id>STEM CELL PGI</org_study_id>
    <nct_id>NCT01694173</nct_id>
  </id_info>
  <brief_title>Tissue Distribution of F18-FDG Labelled Autologous Bone Marrow Derived Stem Cells in Patients With Type 2 DM</brief_title>
  <official_title>Tissue Distribution of F18-FDG Labelled Autologous Bone Marrow Derived Stem Cells in Patients With Type 2 Diabetes Mellitus</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Postgraduate Institute of Medical Education and Research</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Indian Council of Medical Research</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Postgraduate Institute of Medical Education and Research</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Investigators purpose is to track stem cells in vivo in the type 2 diabetes mellitus patients&#xD;
      after the same have been labelled with positron emission tomography tracer F18-FDG; as it is&#xD;
      assumed that the therapeutic outcome will profoundly depend on the delivery of these cells to&#xD;
      pancreas. Biodistribution and quantification studies will be done at 30 minutes and 90&#xD;
      minutes of stem cell infusion.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Autologous bone marrow derived stem cells have a promising potential in regenerative&#xD;
      medicine. In particular the past decade has garnered a great interest in cellular therapy for&#xD;
      treating Type2 diabetes mellitus. The pertinent questions in regenerative medicine today are&#xD;
      to know about the homing, survival, differentiation and functionality of the cells and based&#xD;
      on these to find out the adequate administration methods and choose the optimal dose and cell&#xD;
      types. Various modalities have been used in the preclinical and clinical trials. These&#xD;
      include MRI,optical imaging in the form of bioluminescence and fluorescence, quantum dots,&#xD;
      SPECT and PET/CT imaging. However the methods which are suitable for stem cell tracking in&#xD;
      small animals are not easily translated for human trials. In humans PET/CT imaging with its&#xD;
      reasonable resolution and unique ability to combine anatomical and functional imaging is&#xD;
      considered to be the best bet yet. Hence we intend to label the autologous bone marrow&#xD;
      derived stem cells with PET tracer F18-FDG and carry out biodistribution studies, our&#xD;
      ultimate aim being to study how in vivo distribution of the cells affect therapeutic&#xD;
      efficacy.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>December 2010</start_date>
  <completion_date type="Anticipated">February 2013</completion_date>
  <primary_completion_date type="Actual">August 2012</primary_completion_date>
  <phase>Phase 2/Phase 3</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>• Increment in glucagon stimulated C - peptide levels at the end of 6 months of ABMSCT, as compared to baseline</measure>
    <time_frame>6 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>• Any reduction in requirement of insulin dosage measured as a percentage decrease from baseline • Improvement of HbA1c levels as compared to baseline</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Anticipated">28</enrollment>
  <condition>Type 2 Diabetes Mellitus</condition>
  <arm_group>
    <arm_group_label>Stem cell therapy - SPD artery</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Stem cells will be infused into the superior pancreaticoduodenal artery.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Stem cell therapy - splenic artery</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Stem cells will be infused into the splenic artery.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Stem cell therapy-intravenous</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Stem cells will be given intravenously.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Normal saline placebo -sham procedure</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Sham procedure with infusion of normal saline.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Stem cell therapy- SPD artery</intervention_name>
    <description>A total of 28 patients will be enrolled and randomized to four groups of 7 patients each. 7 patients will receive stem cell infusion into the superior pancreaticoduodenal artery. Another 7 patients will be given stem cell infusion into the splenic artery. The next batch of 7 patients will receive stem cell infusion from the peripheral intravenous route and 7 patients will act as controls undergoing a sham procedure with infusion of normal saline.</description>
    <arm_group_label>Stem cell therapy - SPD artery</arm_group_label>
    <other_name>Autologous bone marrow derived stem cells</other_name>
    <other_name>Bone marrow mononuclear cells</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Stem cell therapy- splenic artery</intervention_name>
    <description>7 patients will receive stem cells infusion through splenic artery.</description>
    <arm_group_label>Stem cell therapy - splenic artery</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Stem cell therapy-intravenous</intervention_name>
    <description>7 patients will receive stem cells infusion through peripheral intravenous route.</description>
    <arm_group_label>Stem cell therapy-intravenous</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Normal saline placebo -sham procedure</intervention_name>
    <description>7 patients will receive infusion of normal saline and will act as control groups</description>
    <arm_group_label>Normal saline placebo -sham procedure</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with T2DM between 30 and 70 years of age.&#xD;
&#xD;
          -  Failure to triple OHA and on stable doses of insulin for at least 3 months.&#xD;
&#xD;
          -  On vildagliptin, pioglitazone and metformin for at least 3 months along with Insulin&#xD;
             to maintain euglycemia.&#xD;
&#xD;
          -  HbA1c of 6.5-7.5%&#xD;
&#xD;
          -  Insulin requirement ≥0.4 IU/kg/d.&#xD;
&#xD;
          -  Glutamic acid decarboxylase (GAD 65) antibody negative status.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with T1DM or secondary diabetes.&#xD;
&#xD;
          -  Patients with serum creatinine &gt; 1.5 mg/dl.&#xD;
&#xD;
          -  Abnormal liver function tests (defined as value of transaminases &gt; 3 times the upper&#xD;
             value of normal or serum bilirubin higher than normal for the reference value for the&#xD;
             laboratory).&#xD;
&#xD;
          -  History of pancreatitis&#xD;
&#xD;
          -  Seropositivity for HIV, HBsAg and HCV.&#xD;
&#xD;
          -  History of myocardial infarction or unstable angina in the previous 3 months.&#xD;
&#xD;
          -  History of malignancy&#xD;
&#xD;
          -  Patients with active infections.&#xD;
&#xD;
          -  Female patients who are pregnant or lactating&#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>Bhagwant R Mittal, MBBS,DRM,MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Post Graduate Institute of Medical Education and Research</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Vikas Sood, MBBS, DRM</last_name>
    <phone>9779737349</phone>
    <email>vikasvineeta@rediffmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Anil Bhansali, MBBS, MD, DM</last_name>
    <email>anilbhansali_endocrine@rediffmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>PGIMER</name>
      <address>
        <city>Chandigarh</city>
        <country>India</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Vikas Sood, MBBS, DRM</last_name>
      <phone>009779737349</phone>
      <email>vikasvineeta@rediffmail.com</email>
    </contact>
    <contact_backup>
      <last_name>Anil Bhansali, MBBS,MD,DM</last_name>
      <phone>001722756583</phone>
      <email>anilbhansali_endocrine@rediffmail.com</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>India</country>
  </location_countries>
  <verification_date>September 2012</verification_date>
  <study_first_submitted>September 24, 2012</study_first_submitted>
  <study_first_submitted_qc>September 24, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 27, 2012</study_first_posted>
  <last_update_submitted>September 28, 2012</last_update_submitted>
  <last_update_submitted_qc>September 28, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 1, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Postgraduate Institute of Medical Education and Research</investigator_affiliation>
    <investigator_full_name>Dr Vikas Sood</investigator_full_name>
    <investigator_title>Ph D Student, Dept of Nuclear medicine</investigator_title>
  </responsible_party>
  <keyword>Type 2 diabetes mellitus, F18-FDG labelled stem cells</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/NCT01694173
org study id: STEM CELL PGI
nct id: NCT01694173
lead sponsor: 
collaborator: 
has dmc: Yes
Investigators purpose is to track stem cells in vivo in the type 2 diabetes mellitus patients
      after the same have been labelled with positron emission tomography tracer F18-FDG; as it is
      assumed that the therapeutic outcome will profoundly depend on the delivery of these cells to
      pancreas. Biodistribution and quantification studies will be done at 30 minutes and 90
      minutes of stem cell infusion.
Autologous bone marrow derived stem cells have a promising potential in regenerative
      medicine. In particular the past decade has garnered a great interest in cellular therapy for
      treating Type2 diabetes mellitus. The pertinent questions in regenerative medicine today are
      to know about the homing, survival, differentiation and functionality of the cells and based
      on these to find out the adequate administration methods and choose the optimal dose and cell
      types. Various modalities have been used in the preclinical and clinical trials. These
      include MRI,optical imaging in the form of bioluminescence and fluorescence, quantum dots,
      SPECT and PET/CT imaging. However the methods which are suitable for stem cell tracking in
      small animals are not easily translated for human trials. In humans PET/CT imaging with its
      reasonable resolution and unique ability to combine anatomical and functional imaging is
      considered to be the best bet yet. Hence we intend to label the autologous bone marrow
      derived stem cells with PET tracer F18-FDG and carry out biodistribution studies, our
      ultimate aim being to study how in vivo distribution of the cells affect therapeutic
      efficacy.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: • Increment in glucagon stimulated C - peptide levels at the end of 6 months of ABMSCT, as compared to baseline
time frame: 6 months
measure: • Any reduction in requirement of insulin dosage measured as a percentage decrease from baseline • Improvement of HbA1c levels as compared to baseline
time frame: 6 months
arm group label: Stem cell therapy - SPD artery
arm group type: Experimental
description: Stem cells will be infused into the superior pancreaticoduodenal artery.
arm group label: Stem cell therapy - splenic artery
arm group type: Active Comparator
description: Stem cells will be infused into the splenic artery.
arm group label: Stem cell therapy-intravenous
arm group type: Active Comparator
description: Stem cells will be given intravenously.
arm group label: Normal saline placebo -sham procedure
arm group type: Placebo Comparator
description: Sham procedure with infusion of normal saline.
intervention type: Other
intervention name: Stem cell therapy- SPD artery
description: A total of 28 patients will be enrolled and randomized to four groups of 7 patients each. 7 patients will receive stem cell infusion into the superior pancreaticoduodenal artery. Another 7 patients will be given stem cell infusion into the splenic artery. The next batch of 7 patients will receive stem cell infusion from the peripheral intravenous route and 7 patients will act as controls undergoing a sham procedure with infusion of normal saline.
arm group label: Stem cell therapy - SPD artery
other name: Autologous bone marrow derived stem cells
other name: Bone marrow mononuclear cells
intervention type: Other
intervention name: Stem cell therapy- splenic artery
description: 7 patients will receive stem cells infusion through splenic artery.
arm group label: Stem cell therapy - splenic artery
intervention type: Other
intervention name: Stem cell therapy-intravenous
description: 7 patients will receive stem cells infusion through peripheral intravenous route.
arm group label: Stem cell therapy-intravenous
intervention type: Other
intervention name: Normal saline placebo -sham procedure
description: 7 patients will receive infusion of normal saline and will act as control groups
arm group label: Normal saline placebo -sham procedure
criteria: 
gender: All
minimum age: 30 Years
maximum age: 70 Years
healthy volunteers: No
last name: Bhagwant R Mittal, MBBS,DRM,MD
role: Principal Investigator
affiliation: Post Graduate Institute of Medical Education and Research
last name: Vikas Sood, MBBS, DRM
phone: 9779737349
email: vikasvineeta@rediffmail.com
last name: Anil Bhansali, MBBS, MD, DM
email: anilbhansali_endocrine@rediffmail.com
facility: 
status: Recruiting
contact: 
contact backup: 
country: India
responsible party type: Principal Investigator
investigator affiliation: Postgraduate Institute of Medical Education and Research
investigator full name: Dr Vikas Sood
investigator title: Ph D Student, Dept of Nuclear medicine
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2