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

Post Graduate Institute of Medical Education and Research, Chandigarh

Status and phase: Completed; Phase 2; Phase 1

Conditions: Diabetes Mellitus, Non-Insulin-Dependent

Treatments: Procedure: stem cells

Study type: Interventional

Funder types: Other

Identifiers

NCT02585505

PGI NUC MED

Details and patient eligibility

About

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.

Full 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.

Enrollment: 21 patients

Sex: All

Ages: 30 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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21 participants in 3 patient groups

Intravenous

Active Comparator group

Description:

stem cells will be injected through intravenously in the subjects

Treatment:

Procedure: stem cells

superior pancreaticoduodenal

Active Comparator group

Description:

stem cells

Treatment:

Procedure: stem cells

splenic artery

Active Comparator group

Description:

stem cells will be injected through splenic in the subjects

Treatment:

Procedure: stem cells