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NCT Number: NCT02585505

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

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.

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Key information

Conditions

Diabetes Mellitus, Non-Insulin-Dependent Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

30 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Stem cells

Procedure

stem cell will be injected

Primary outcomes

  1. Increase in glucagon stimulated C peptide level

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Post Graduate Institute of Medical Education and Research, Chandigarh

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Oct 23, 2015
Registry last updated
Oct 23, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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