A Phase 2/3 interventional study of mesenchymal stem cell transplantation and control in Type 2 Diabetes Mellitus, sponsored by Post Graduate Institute of Medical Education and Research, Chandigarh. Completed at 1 site in India. Open to participants aged 30 Years to 70 Years. Per ClinicalTrials.gov, last updated 2015-10-27.
Sponsored by Post Graduate Institute of Medical Education and Research, Chandigarh · Phase 2/3, Interventional, and Treatment
The purpose of this study is to improve the blood glucose level in type 2 diabetic patients.
We hypothesize that Autologous bone marrow derived stem cells which would be expanded into culture and their subsequent transplant into the pancreas of patients with T2DM, aged 30 - 70 years with triple oral hypoglycemic agent failure and on insulin(>0.4 U/ kg body weight/day) will lead to abolition or reduction of insulin requirement by more than or equal to 50% in these patients over a period of 6 months. It is assumed that stem cell in these patients leads to increased angiogenesis, secretion of various cytokines and upregulation of pancreatic transcription factors and Vascular endothelial growth factor(VEGF) and creates a micro-environment which supports beta cell/resident stem cell activation and survival.
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's enrollment of 30 is below the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →Post Graduate Institute of Medical Education and Research, Chandigarh is the lead sponsor of 290 studies on the registry; 42 are open to participants now.
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Patients with type 2 diabetes mellitus between 30 and 70 years of age.
Exclusion Criteria:
Patients with Type 2 Diabetes mellitus on full doses of Vildagliptin+Pioglitazone+Metformin and requiring Insulin at dose of \>0.4unit/Kg for blood glucose control.
Biological: mesenchymal stem cell transplantation
vildagliptin+metformin+pioglitazone and on Insulin \>0.4unit/Kg who will act as active control.They will receive injectable placebo at Day 1 in addition to above and will be followed up for 6 months.Follow up investigation and Insulin dose titration will be similar to Group 1
Other: control
Patients with Type 2 Diabetes mellitus on full doses of Vildagliptin+Pioglitazone+Metformin and requiring Insulin at dose of \>0.4unit/Kg for blood glucose control.
Biological: MNC's TRANSPLANTATION
20 - 30 ml of bone marrow will be aspirated and layered on density gradient medium (Ficoll - hypaque ) and stem cells will be separated. Separated mono nucleated cells will be dissolved in minimum essential medium and inoculated in culturing flask and mesenchymal will be allowed to adhere to culturing flask and mesenchymal stem cell will be injected into superior pancreatic duodenal artery . Patients will be urged to monitor and document blood glucose readings for next 6 months. Glucagon stimulated C - peptide HYPERGLYCEMIC CLAMP FOR ASSESSMENT OF BETA CELL FUNCTION , Homeostasis Model of Assessment - Insulin Resistance and Beta cell function ,HbA1c, lipid profile and biochemistry will be done at baseline and 6 months .
5 ml of bone marrow will be aspirated and 3 mL of Vitamin B complex will be injected through transfemoral route into superior pancreatico-duodenal artery. Patients will be urged to monitor and document blood glucose readings for next 6 months. Glucagon stimulated C - peptide,HYPERGLYCEMIC CLAMP TO ASSESS BETA CELL FUNCTION. Homeostasis Model of Assessment - Insulin Resistance and Beta cell function ,HbA1c, lipid profile and biochemistry will be done at baseline and 6 months .
20 - 30 ml of bone marrow will be aspirated and layered on density gradient medium (Ficoll - hypaque ) and stem cells will be separated. Separated mono nucleated cells will injected into superior pancreatico duodenal artery. Patients will be urged to monitor and document blood glucose readings for next 6 months. Glucagon stimulated C - peptide HYPERGLYCEMIC CLAMP FOR ASSESSMENT OF BETA CELL FUNCTION , AND EUGLYCEMIC CLAMP TO ASSESS INSULIN SENSITIVITY .Homeostasis Model of Assessment - Insulin Resistance and Beta cell function ,HbA1c, lipid profile and biochemistry will be done at baseline and 6 months .
Reduction of insulin requirement by ≥ 50% by the end of 6 months of autologous bone marrow derived stem cell transplantation and Improvement in Glucagon stimulated C - peptide levels and hyperglycemic clamp for assessment of beta cell function
Time frame: 6 months
This study is completed, as verified in Oct 2015. You cannot join it, but the record below documents what was studied.
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Post Graduate Institute of Medical Education and Research, Chandigarh