NCT01694173

Tissue Distribution of F18-FDG Labelled Autologous Bone Marrow Derived Stem Cells in Patients With Type 2 DM

Tissue Distribution of F18-FDG Labelled Autologous Bone Marrow Derived Stem Cells in Patients With Type 2 Diabetes Mellitus

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 28 (estimated)
• Sponsor: Post Graduate Institute of Medical Education and Research, Chandigarh · Academic / Other
• Sex: All
• Age: 30 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Investigators purpose is to track stem cells in vivo in the type 2 diabetes mellitus patients after the same have been labelled with positron emission tomography tracer F18-FDG; as it is assumed that the therapeutic outcome will profoundly depend on the delivery of these cells to pancreas. Biodistribution and quantification studies will be done at 30 minutes and 90 minutes of stem cell infusion.

Detailed description

Autologous bone marrow derived stem cells have a promising potential in regenerative medicine. In particular the past decade has garnered a great interest in cellular therapy for treating Type2 diabetes mellitus. The pertinent questions in regenerative medicine today are to know about the homing, survival, differentiation and functionality of the cells and based on these to find out the adequate administration methods and choose the optimal dose and cell types. Various modalities have been used in the preclinical and clinical trials. These include MRI,optical imaging in the form of bioluminescence and fluorescence, quantum dots, SPECT and PET/CT imaging. However the methods which are suitable for stem cell tracking in small animals are not easily translated for human trials. In humans PET/CT imaging with its reasonable resolution and unique ability to combine anatomical and functional imaging is considered to be the best bet yet. Hence we intend to label the autologous bone marrow derived stem cells with PET tracer F18-FDG and carry out biodistribution studies, our ultimate aim being to study how in vivo distribution of the cells affect therapeutic efficacy.

Conditions

• Type 2 Diabetes Mellitus

Interventions

Type	Name	Description
OTHER	Stem cell therapy- SPD artery	A total of 28 patients will be enrolled and randomized to four groups of 7 patients each. 7 patients will receive stem cell infusion into the superior pancreaticoduodenal artery. Another 7 patients will be given stem cell infusion into the splenic artery. The next batch of 7 patients will receive stem cell infusion from the peripheral intravenous route and 7 patients will act as controls undergoing a sham procedure with infusion of normal saline.
OTHER	Stem cell therapy- splenic artery	7 patients will receive stem cells infusion through splenic artery.
OTHER	Stem cell therapy-intravenous	7 patients will receive stem cells infusion through peripheral intravenous route.
OTHER	Normal saline placebo -sham procedure	7 patients will receive infusion of normal saline and will act as control groups

Timeline

• Start date: 2010-12-01
• Primary completion: 2012-08-01
• Completion: 2013-02-01
• First posted: 2012-09-27
• Last updated: 2012-10-01

Locations

1 site across 1 country: India