Efficacy Of Autologous Bone Marrow Derived Stem Cell Transplantation In Patients With Type 2 Diabetes Mellitus-2
1 other identifier
observational
30
1 country
1
Brief Summary
The purpose of this study is to improve blood glucose control in Type 2 Diabetes mellitus patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Nov 2009
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2009
CompletedFirst Submitted
Initial submission to the registry
February 8, 2010
CompletedFirst Posted
Study publicly available on registry
February 9, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2011
CompletedOctober 21, 2015
October 1, 2015
1.7 years
February 8, 2010
October 19, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Reduction of insulin requirement by ≥ 50% by the end of 6 months of ABMSCT and Improvement in Glucagon stimulated C - peptide levels .
6 months
Secondary Outcomes (1)
Any reduction in requirement of insulin dosage and any improvement of HbA1c levels as compared to controls.
6 months
Study Arms (2)
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
Group-2: Controls
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.
Interventions
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 .
Eligibility Criteria
Patients with type 2 Diabetes mellitus with triple Oral hypoglycemic failure and on Insulin for glycemic control
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Post Graduate Institute of Medical Education and Research
Chandigarh, Chandigarh UT, India
Related Publications (1)
Bhansali A, Upreti V, Khandelwal N, Marwaha N, Gupta V, Sachdeva N, Sharma RR, Saluja K, Dutta P, Walia R, Minz R, Bhadada S, Das S, Ramakrishnan S. Efficacy of autologous bone marrow-derived stem cell transplantation in patients with type 2 diabetes mellitus. Stem Cells Dev. 2009 Dec;18(10):1407-16. doi: 10.1089/scd.2009.0164.
PMID: 19686048RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Anil Bhansali, MD.,DM
Post Graduate Institute of Medical Education and Research, Chandigarh
- PRINCIPAL INVESTIGATOR
Neelam Marwaha, MD.,DM
Post Graduate Institute of Medical Education and Research, Chandigarh
- PRINCIPAL INVESTIGATOR
N Khandelwal, MD
Post Graduate Institute of Medical Education and Research, Chandigarh
- PRINCIPAL INVESTIGATOR
B.R. Mittal, MD
Post Graduate Institute of Medical Education and Research, Chandigarh
- PRINCIPAL INVESTIGATOR
Prem Kumar, MD
Post Graduate Institute of Medical Education and Research, Chandigarh
- PRINCIPAL INVESTIGATOR
Rama Walia, MD.,DM
Post Graduate Institute of Medical Education and Research, Chandigarh
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- head of department
Study Record Dates
First Submitted
February 8, 2010
First Posted
February 9, 2010
Study Start
November 1, 2009
Primary Completion
July 1, 2011
Study Completion
July 1, 2011
Last Updated
October 21, 2015
Record last verified: 2015-10