Bone Marrow Derived Stem Cell Transplantation in T2DM

Efficacy and Safety of Autologous Bone Marrow Derived Stem Cell Transplantation in Patients With Type 2 Diabetes Mellitus

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.

Inclusion Criteria:

Patients with type 2 diabetes mellitus between 30 and 70 years of age.

• Failure to triple oral hypoglycemic agent and on stable doses of insulin for at least 3 months.
• On vildagliptin,pioglitazone and metformin for at least 3 months along with Insulin to maintain euglycemia.
• HbA1c < 7.5%.
• Insulin requirement ≥0.4 IU/kg/d.
• 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 hepatitis C virus (HCV).
• History of myocardial infarction or unstable angina in the previous 3 months.
• History of malignancy
• Patients with active infections.