Efficacy Of Autologous Bone Marrow Derived Stem Cell Transplantation In Patients With Type 2 Diabetes Mellitus
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Reduction of insulin requirement by ≥ 50% by the end of 6 months of ABMSCT and Improvement in Glucagon stimulated C - peptide levels .
Study Overview
Brief Summary
The purpose of this study is to improve blood glucose control in Type 2 Diabetes mellitus patients.
Detailed Description
We hypothesize that Autologous bone marrow derived stem cell transplantation(ABMSCT)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 ABMSCT 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 microenvironment which supports beta cell/resident stem cell activation and survival.
Study Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 30 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients with type 2 diabetes mellitus between 30 and 70 years of age.
- •Failure to triple OHA and on stable doses of insulin for atleast 3 months.
- •On vildagliptin,pioglitazone and metformin for atleast 3 months along with Insulin to maintain euglycemia.
- •HbA1c < 8.5%.
- •Insulin requirement ≥0.4 IU/kg/d.
- •GAD antibody negative status.
Exclusion Criteria
- •Patients with T1DM 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/ cholelitiasis/ cholecystectomy
- •Seropositivity for HIV, HBsAg and HCV.
- •History of myocardial infarction or unstable angina in the previous 3 months.
- •History of malignancy
- •Patients with active infections.
Outcomes
Primary Outcomes
Reduction of insulin requirement by ≥ 50% by the end of 6 months of ABMSCT and Improvement in Glucagon stimulated C - peptide levels .
Time Frame: 6 months
Secondary Outcomes
- Any reduction in requirement of insulin dosage and any improvement of HbA1c levels as compared to controls.(6 months)
Investigators
Anil Bhansali
head of department
Post Graduate Institute of Medical Education and Research, Chandigarh