Bone Marrow Derived Stem Cell Transplantation in T2DM
- Conditions
- Type 2 Diabetes Mellitus
- Registration Number
- NCT01759823
- Lead Sponsor
- Post Graduate Institute of Medical Education and Research, Chandigarh
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method 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 6 months
- Secondary Outcome Measures
Name Time Method
Related Research Topics
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Trial Locations
- Locations (1)
Postgraduate Institute of Medical Education and Research
🇮🇳Chandigarh, UT, India
Postgraduate Institute of Medical Education and Research🇮🇳Chandigarh, UT, India