NCT01065298

Efficacy Of Autologous Bone Marrow Derived Stem Cell Transplantation In Patients With Type 2 Diabetes Mellitus-2

Efficacy Of Autologous Bone Marrow Derived Stem Cell Transplantation In Patients With Type 2 Diabetes Mellitus

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 30 (actual)
• Sponsor: Post Graduate Institute of Medical Education and Research, Chandigarh · Academic / Other
• Sex: All
• Age: 30 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Type 2 Diabetes Mellitus

Interventions

Type	Name	Description
BIOLOGICAL	stem cell transplantation	Group 1: 200 - 250 ml of bone marrow will be aspirated and layered on density gradient medium (Ficoll - Hyperaque) and stem cells will be separated. Separated MNC's will be tagged with FDG-PET and injected into superior pancreatico duodenal artery and an PET scan will be done 2 hours later to see the percentage of stem cells homing in to pancreas. After 8 weeks G-CSF(10mcg/Kg/day) will be given subcutaneous for 5 days to achieve a Leucocyte count of \>40,000/mm3. Patients will be urged to monitor and document blood glucose readings for next 6 months. Glucagon stimulated C - peptide, plasma Insulin, HOMA-IR , HOMA-B ,HbA1c, lipid profile and biochemistry will be done at baseline and 6 months .

Timeline

• Start date: 2009-11-01
• Primary completion: 2011-07-01
• Completion: 2011-07-01
• First posted: 2010-02-09
• Last updated: 2015-10-21

Locations

1 site across 1 country: India