Cultured Mesenchymal Stem Cell Transplantation in T2DM

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by Postgraduate Institute of Medical Education and Research
Sponsor:
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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 18, 2014