Cultured Mesenchymal Stem Cell Transplantation in T2DM
This study is currently recruiting participants.
Verified January 2013 by Postgraduate Institute of Medical Education and Research
Sponsor:
Postgraduate Institute of Medical Education and Research
Information provided by (Responsible Party):
pinaki dutta, Postgraduate Institute of Medical Education and Research
ClinicalTrials.gov Identifier:
NCT01759823
First received: December 30, 2012
Last updated: January 2, 2013
Last verified: January 2013
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Purpose
The purpose of this study is to improve the blood glucose level in type 2 diabetic patients.
| Condition | Intervention | Phase |
|---|---|---|
|
Type 2 Diabetes Mellitus |
Biological: Cultured mesenchymal stem cell transplantation Other: control |
Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment |
| Official Title: | Efficacy and Safety of Autologous Bone Marrow Derived Mesenchymal Stem Cell Transplantation in Patients With Type 2 Diabetes Mellitus |
Resource links provided by NLM:
Further study details as provided by Postgraduate Institute of Medical Education and Research:
Primary Outcome Measures:
- Reduction of insulin requirement by ≥ 50% by the end of 6 months of autologous bone marrow mesenchymal stem cell transplantation and Improvement in Glucagon stimulated C - peptide levels and insulin sensitivity by HYPERINSULINEMIC EUGLYCEMIC CLAMP [ Time Frame: 6 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 30 |
| Study Start Date: | December 2012 |
| Estimated Study Completion Date: | June 2015 |
| Estimated Primary Completion Date: | December 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Cultured mesenchymal stem cell transplantation
Patients with Type 2 Diabetes mellitus on full doses of Vildagliptin+Pioglitazone+Metformin and requiring Insulin at dose of >0.4unit/Kg for blood glucose control.
|
Biological: Cultured mesenchymal stem cell transplantation
20 - 30 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 be dissolved in minimum essential medium and inoculated in culturing flask and mesenchymal will be allowed to adhere to culturing flask and mesenchymal stem cell will be injected into superior pancreatic duodenal artery . Patients will be urged to monitor and document blood glucose readings for next 6 months. Glucagon stimulated C - peptide,hyperinsulinemic euglycemic clamp for assessment of insulin resistance, plasma Insulin, Homeostasis Model of Assessment - Insulin Resistance and Beta cell function ,HbA1c, lipid profile and biochemistry will be done at baseline and 6 months .
|
|
Sham Comparator: Control
vildagliptin+metformin+pioglitazone and on Insulin >0.4unit/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
|
Other: control
5 ml of bone marrow will be aspirated and 3 mL of Vitamin B complex will be injected through transfemoral route into superior pancreatico-duodenal artery. Patients will be urged to monitor and document blood glucose readings for next 6 months. Glucagon stimulated C - peptide,hyperinsulinemic euglycemic clamp for assessment of insulin resistance, plasma Insulin, Homeostasis Model of Assessment - Insulin Resistance and Beta cell function ,HbA1c, lipid profile and biochemistry will be done at baseline and 6 months .
|
Detailed Description:
We hypothesize that Autologous bone marrow derived mesenchymal stem cells which would be expanded into culture and their subsequent transplant 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 cultured mesenchymal stem cell 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 micro-environment which supports beta cell/resident stem cell activation and survival.
Eligibility| Ages Eligible for Study: | 30 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
Patients with type 2 diabetes mellitus between 30 and 70 years of age.
- 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01759823
Contacts
| Contact: Pinaki Dutta, MBBS, MD,DM | 9463001233 | bhansali.o4@gmail.com |
Locations
| India | |
| Postgraduate Institute of Medical Education and Research | Recruiting |
| Chandigarh, UT, India, 160012 | |
| Contact: Pinaki Dutta, MBBS,MD,DM 9463001233 bhansali.o4@gmail.com | |
| Principal Investigator: Pinaki Dutta | |
Sponsors and Collaborators
Postgraduate Institute of Medical Education and Research
Investigators
| Study Chair: | Pinaki Dutta | Post Graduate Institute Of Medical Education And Research, Chandigarh |
| Principal Investigator: | V Jha | Postgraduate Institute of Medical Education and Research, Chandigarh |
| Principal Investigator: | Neelam Marwaha | Postgraduate Institute of Medical Education and Research , Chandigarh |
More Information
Publications:
| Responsible Party: | pinaki dutta, Assistant Professor, Postgraduate Institute of Medical Education and Research |
| ClinicalTrials.gov Identifier: | NCT01759823 History of Changes |
| Other Study ID Numbers: | Mesenchymal stem cell in T2DM |
| Study First Received: | December 30, 2012 |
| Last Updated: | January 2, 2013 |
| Health Authority: | India: Indian Council of Medical Research |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |
ClinicalTrials.gov processed this record on May 19, 2013