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

Phase 1

Completed

• Conditions: Diabetes Mellitus, Non-Insulin-Dependent
• Interventions: Procedure: stem cells

• Registration Number: NCT02585505
• Lead Sponsor: Post Graduate Institute of Medical Education and Research, Chandigarh

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.

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.

Study Timeline

• Study Start: 2010-12
• Primary Completion: 2012-06
• Study Completion: 2012-12
• Status Verified: 2015-10
• Study First Submitted: 2015-10-19
• Study First Submitted QC: 2015-10-22
• Last Update Submitted: 2015-10-22
• Study First Posted: 2015-10-23
• Last Update Posted: 2015-10-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
superior pancreaticoduodenal	stem cells	stem cells
splenic artery	stem cells	stem cells will be injected through splenic in the subjects
Intravenous	stem cells	stem cells will be injected through intravenously in the subjects

Primary Outcome Measures

Name	Time	Method
Increase in glucagon stimulated C peptide level	6 months