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

Diabetes Mellitus, Non-Insulin-Dependent Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02585505
• Other study ID #: PGI NUC MED
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: October 19, 2015
• Last updated: October 22, 2015
• Start date: December 2010
• Est. completion date: December 2012

Study information

• Verified date: October 2015
• Source: Postgraduate Institute of Medical Education and Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: December 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Non-Insulin-Dependent
• Diabetes Mellitus, Type 2

Intervention

Procedure:
• stem cells
stem cell will be injected

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Postgraduate Institute of Medical Education and Research

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Increase in glucagon stimulated C peptide level		6 months	No