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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Tissue Distribution of F18-FDG Labeled Autologous Bone Marrow Derived Stem Cells in Patients With Type2 Diabetes Mellitus

Conditions
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Diabetes Mellitus, Non-Insulin-Dependent

Intervention / Treatment
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* Procedure: stem cells


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intravenous<br>stem cells will be injected through intravenously in the subjects | Procedure: stem cells<br>* stem cell will be injected<br>|
| Active Comparator: superior pancreaticoduodenal<br>stem cells | Procedure: stem cells<br>* stem cell will be injected<br>|
| Active Comparator: splenic artery<br>stem cells will be injected through splenic in the subjects | Procedure: stem cells<br>* stem cell will be injected<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Increase in glucagon stimulated C peptide level |  | 6 months |