Efficacy Of Autologous Bone Marrow Derived Stem Cell Transplantation In Patients With Type 2 Diabetes Mellitus-2
Recruitment status was Recruiting
The purpose of this study is to improve blood glucose control in Type 2 Diabetes mellitus patients.
Type 2 Diabetes Mellitus
Biological: stem cell transplantation
|Study Design:||Observational Model: Case Control
Time Perspective: Prospective
|Official Title:||Efficacy Of Autologous Bone Marrow Derived Stem Cell Transplantation In Patients With Type 2 Diabetes Mellitus|
- 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 ] [ Designated as safety issue: No ]
- Any reduction in requirement of insulin dosage and any improvement of HbA1c levels as compared to controls. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
|Study Start Date:||November 2009|
|Estimated Study Completion Date:||July 2011|
|Estimated Primary Completion Date:||July 2011 (Final data collection date for primary outcome measure)|
Group 1:Stem cell Recipient
Patients with Type 2 Diabetes mellitus on full doses of Vildagliptin+Pioglitazone+Metformin and requiring Insulin at dose of >0.4U/Kg for blood glucose control. They will undergo stem cell therapy initialy and G-CSF therapy at 2 months
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 .
Other Name: Autologous Bone marrow derived stem cell transplantation
Type 2 Diabetes mellitus patients on full doses of vildagliptin+metformin+pioglitazone and on Insulin >0.4U/Kg who will act as active control.They will receive injectable placebo at Day 1 in addition to above and will be followed up for 6 months.Follow up investigation and Insulin dose titration will be similar to Group 1.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01065298
|Contact: Anil Bhansali, MD.,DM||2756583 ext firstname.lastname@example.org|
|Contact: Prem kumar, MDemail@example.com|
|Post Graduate Institute of Medical Education and Research||Recruiting|
|Chandigarh, Chandigarh UT, India|
|Principal Investigator: Prem Kumar, MD|
|Sub-Investigator: Shobhit Bhansali, Msc|
|Study Chair:||Anil Bhansali, MD.,DM||Postgraduate Institute of Medical Education and Research|
|Principal Investigator:||Neelam Marwaha, MD.,DM||Postgraduate Institute of Medical Education and Research|
|Principal Investigator:||N Khandelwal, MD||Postgraduate Institute of Medical Education and Research|
|Principal Investigator:||B.R. Mittal, MD||Postgraduate Institute of Medical Education and Research|
|Principal Investigator:||Prem Kumar, MD||Postgraduate Institute of Medical Education and Research|
|Principal Investigator:||Rama Walia, MD.,DM||Postgraduate Institute of Medical Education and Research|