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| Name | Class |
|---|---|
| Indian Council of Medical Research | OTHER_GOV |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stem cell therapy - SPD artery | Experimental | Stem cells will be infused into the superior pancreaticoduodenal artery. |
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| Stem cell therapy - splenic artery | Active Comparator | Stem cells will be infused into the splenic artery. |
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| Stem cell therapy-intravenous | Active Comparator | Stem cells will be given intravenously. |
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| Normal saline placebo -sham procedure | Placebo Comparator | Sham procedure with infusion of normal saline. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stem cell therapy- SPD artery | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| • Increment in glucagon stimulated C - peptide levels at the end of 6 months of ABMSCT, as compared to baseline | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| • Any reduction in requirement of insulin dosage measured as a percentage decrease from baseline • Improvement of HbA1c levels as compared to baseline | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Vikas Sood, MBBS, DRM | Contact | 9779737349 | vikasvineeta@rediffmail.com | |
| Anil Bhansali, MBBS, MD, DM | Contact | anilbhansali_endocrine@rediffmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Bhagwant R Mittal, MBBS,DRM,MD | Post Graduate Institute of Medical Education and Research, Chandigarh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PGIMER | Recruiting | Chandigarh | Chandigarh | India |
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| Stem cell therapy- splenic artery | Other | 7 patients will receive stem cells infusion through splenic artery. |
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| Stem cell therapy-intravenous | Other | 7 patients will receive stem cells infusion through peripheral intravenous route. |
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| Normal saline placebo -sham procedure | Other | 7 patients will receive infusion of normal saline and will act as control groups |
|
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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