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Tissue Distribution of F18-FDG Labeled ABMSCT in Patients With Type2 Diabetes Mellitus

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ClinicalTrials.gov Identifier: NCT02585505
Recruitment Status : Completed
First Posted : October 23, 2015
Last Update Posted : October 23, 2015
Sponsor:
Information provided by (Responsible Party):
Anil Bhansali, Postgraduate Institute of Medical Education and Research

Brief Summary:
Stem cells have promising potential in treating diabetes. However the therapeutic outcome in diabetic patients will profoundly depend on their delivery to pancreas. Our objective is to label stem cells with PET tracer F18-FDG to carry out in vivo cell tracking. The labeled stem cells will be given through different routes (intravenous and intraarterial)and tissue distribution studied. Patients will be followed up for the next 6 months. Glucagon stimulated C peptide will be measured at baseline and at 6 months and HOMA IR and HOMA beta will be calculated.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Non-Insulin-Dependent Procedure: stem cells Phase 1 Phase 2

Detailed Description:
Our objective is to label stem cells with PET tracer F18-FDG to carry out in vivo cell tracking. The labeled stem cells will be given through different routes (intravenous and intraarterial)and tissue distribution studied. Patients will be followed up for the next 6 months. Glucagon stimulated C peptide will be measured at baseline and at 6 months and HOMA IR and HOMA beta will be calculated.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Tissue Distribution of F18-FDG Labeled Autologous Bone Marrow Derived Stem Cells in Patients With Type2 Diabetes Mellitus
Study Start Date : December 2010
Actual Primary Completion Date : June 2012
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Intravenous
stem cells will be injected through intravenously in the subjects
Procedure: stem cells
stem cell will be injected

Active Comparator: superior pancreaticoduodenal
stem cells
Procedure: stem cells
stem cell will be injected

Active Comparator: splenic artery
stem cells will be injected through splenic in the subjects
Procedure: stem cells
stem cell will be injected




Primary Outcome Measures :
  1. Increase in glucagon stimulated C peptide level [ Time Frame: 6 months ]


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Ages Eligible for Study:   30 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • • Patients with type 2 diabetes mellitus between 30 and 65 years of age.

    • Duration of diabetes ≥ 5 years.
    • Failure to triple OHA in optimal doses {glimepiride (4 gm), metformin(2-2.5 gm) and pioglitazone(15mg)}.
    • Requiring insulin therapy for last six month
    • On stable doses of insulin (≥0.4 IU/kg/day, Vildagliptin, metformin (2 gm), pioglitazone (15mg) for last three months.
    • GAD antibody negative status.

Exclusion Criteria:

  • Patients with type 1 diabetes mellitus or secondary diabetes
  • Patients with serum creatinine > 1.5 mg/dL
  • Abnormal liver function tests (defined as value of transaminases > 3 times the upper value of normal or serum bilirubin higher than normal for the reference value for the laboratory).
  • History of cholecystitis/ cholelithiasis/ cholecystectomy.
  • Seropositivity for HIV, HBsAg and HCV.
  • History of myocardial infarction or unstable angina or any cardiovascular events in the previous 3 months.

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Responsible Party: Anil Bhansali, Head, Dept of Endocrinology, Postgraduate Institute of Medical Education and Research
ClinicalTrials.gov Identifier: NCT02585505     History of Changes
Other Study ID Numbers: PGI NUC MED
First Posted: October 23, 2015    Key Record Dates
Last Update Posted: October 23, 2015
Last Verified: October 2015

Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases