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Bone Marrow Derived Stem Cell Transplantation in T2DM

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01759823
Recruitment Status : Completed
First Posted : January 3, 2013
Last Update Posted : October 27, 2015
Sponsor:
Information provided by (Responsible Party):
Anil Bhansali, Postgraduate Institute of Medical Education and Research

Tracking Information
First Submitted Date  ICMJE December 30, 2012
First Posted Date  ICMJE January 3, 2013
Last Update Posted Date October 27, 2015
Study Start Date  ICMJE December 2012
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 17, 2014)
Reduction of insulin requirement by ≥ 50% by the end of 6 months of autologous bone marrow derived stem cell transplantation and Improvement in Glucagon stimulated C - peptide levels and hyperglycemic clamp for assessment of beta cell function [ Time Frame: 6 months ]
Original Primary Outcome Measures  ICMJE
 (submitted: January 2, 2013)
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 ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Bone Marrow Derived Stem Cell Transplantation in T2DM
Official Title  ICMJE Efficacy and Safety of Autologous Bone Marrow Derived Stem Cell Transplantation in Patients With Type 2 Diabetes Mellitus
Brief Summary The purpose of this study is to improve the blood glucose level in type 2 diabetic patients.
Detailed Description We hypothesize that Autologous bone marrow derived 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 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Type 2 Diabetes Mellitus
Intervention  ICMJE
  • Biological: 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 HYPERGLYCEMIC CLAMP FOR ASSESSMENT OF BETA CELL FUNCTION , Homeostasis Model of Assessment - Insulin Resistance and Beta cell function ,HbA1c, lipid profile and biochemistry will be done at baseline and 6 months .
  • 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,HYPERGLYCEMIC CLAMP TO ASSESS BETA CELL FUNCTION. Homeostasis Model of Assessment - Insulin Resistance and Beta cell function ,HbA1c, lipid profile and biochemistry will be done at baseline and 6 months .
  • Biological: MNC's 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 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 .
Study Arms  ICMJE
  • Experimental: 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.
    Intervention: Biological: mesenchymal stem cell transplantation
  • 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
    Intervention: Other: control
  • Experimental: MNC's 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.
    Intervention: Biological: MNC's TRANSPLANTATION
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 2, 2013)
30
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2015
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 30 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE India
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01759823
Other Study ID Numbers  ICMJE stem cell therapy in T2DM
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Anil Bhansali, Postgraduate Institute of Medical Education and Research
Study Sponsor  ICMJE Postgraduate Institute of Medical Education and Research
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: A Bhansali 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
PRS Account Postgraduate Institute of Medical Education and Research
Verification Date October 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP