Bone Marrow Derived Stem Cell Transplantation in T2DM
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of this study is to improve the blood glucose level in type 2 diabetic patients.
    

Detailed description: 
      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.
    

Intervention name(s): mesenchymal stem cell transplantation; control; MNC's TRANSPLANTATION
Intervention type(s): Biological; Other; Biological
Intervention description(s): 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 .
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment