- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02662400
Assessment of Insulin Sensitivity and β Cell Function by Clamps Studies
Assessment of Insulin Sensitivity and β Cell Function by Clamps Studies After Stem Cell Transplantation in T2DM
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The shortcomings can be overcome by the use of stem cells which is an inexhaustible source of β -cells. Stem cells are primitive cells capable of differentiating into mature cells of the body of various lineages. Stem cells can be obtained from various sources like blastocyst (embryonal stem cells), umbilical cord or bone marrow. There is an evidence to suggest that stem cell transplantation can lead to improvement in pancreatic endocrine function and improvement in glycemic control in diabetic mice through various mechanisms such as transdifferentiation or regeneration of endothelial cell in the damaged islets which in turn lead to regeneration of islet cells by paracrine action. However, till date there is no study that demonstrates that stem cell therapy can be effective in patients with T2DM for their glycemic control.
The investigators propose to carry out autologous bone marrow - derived stem cell transplantation (ABMSCT) in patients of T2DM, obtained from their own bone marrow and its superselective injection into the gastroduodenal artery after purification without any immunosuppressive regimen.
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 3
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: MNCs GROUP
Patients with Type 2 Diabetes mellitus
|
200 - 300 ml of bone marrow will be aspirated and layered on density gradient medium (Ficoll - hypaque ) and stem cells will be separated.
Separated mono nucleated cells will injected into superior pancreatico duodenal artery.
Patients will be urged to monitor and document blood glucose readings for next 6 months.
Glucagon stimulated C - peptide HYPERGLYCEMIC CLAMP FOR ASSESSMENT OF BETA CELL FUNCTION , AND EUGLYCEMIC CLAMP TO ASSESS INSULIN SENSITIVITY .Homeostasis Model of Assessment - Insulin Resistance and Beta cell function ,HbA1c, lipid profile and biochemistry will be done at baseline and 6 months
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Improvement in insulin sensitivity after stem cell transplantation
Time Frame: 6 months
|
Stem cells will be transplanted in patients with T2DM.
Pre and Pro stem cell transplantation Insulin sensitivity(pmol/l) will be assessed by euglycemic clamp .
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Improvement in β cell function after stem cell transplantation
Time Frame: 6 months
|
Stem cells will be transplanted in patients with T2DM.
Pre and Pro stem cell transplantation β cell function(nmol/L) will be assessed by hyperglycemia clamp .
|
6 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: anil Bhansali, DM, Postgraduate Institute of Medical Education and Research
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MNCs IN Diabetes
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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