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Bone Marrow Derived Stem Cell Transplantation in T2DM

Primary Purpose

Type 2 Diabetes Mellitus

Status
Completed
Phase
Phase 2
Locations
India
Study Type
Interventional
Intervention
mesenchymal stem cell transplantation
control
MNC's TRANSPLANTATION
Sponsored by
Postgraduate Institute of Medical Education and Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes Mellitus

Eligibility Criteria

30 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Postgraduate Institute of Medical Education and Research

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Sham Comparator

Experimental

Arm Label

mesenchymal stem cell transplantation

Control

MNC's TRANSPLANTATION

Arm Description

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.

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

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
December 30, 2012
Last Updated
October 24, 2015
Sponsor
Postgraduate Institute of Medical Education and Research
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1. Study Identification

Unique Protocol Identification Number
NCT01759823
Brief Title
Bone Marrow Derived Stem Cell Transplantation in T2DM
Official Title
Efficacy and Safety of Autologous Bone Marrow Derived Stem Cell Transplantation in Patients With Type 2 Diabetes Mellitus
Study Type
Interventional

2. Study Status

Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
December 2012 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
October 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Postgraduate Institute of Medical Education and Research

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
mesenchymal stem cell transplantation
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
Sham Comparator
Arm Description
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
Arm Title
MNC's TRANSPLANTATION
Arm Type
Experimental
Arm Description
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 Type
Biological
Intervention Name(s)
mesenchymal stem cell transplantation
Intervention Description
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 .
Intervention Type
Other
Intervention Name(s)
control
Intervention Description
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 .
Intervention Type
Biological
Intervention Name(s)
MNC's TRANSPLANTATION
Intervention Description
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 .
Primary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
A Bhansali
Organizational Affiliation
Post Graduate Institute of Medical Education and Research, Chandigarh
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
V Jha
Organizational Affiliation
Postgraduate Institute of Medical Education and Research, Chandigarh
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Neelam Marwaha
Organizational Affiliation
Postgraduate Institute of Medical Education and Research, Chandigarh
Official's Role
Principal Investigator
Facility Information:
Facility Name
Postgraduate Institute of Medical Education and Research
City
Chandigarh
State/Province
UT
ZIP/Postal Code
160012
Country
India

12. IPD Sharing Statement

Citations:
PubMed Identifier
19686048
Citation
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.
Results Reference
background
PubMed Identifier
28690682
Citation
Bhansali S, Dutta P, Yadav MK, Jain A, Mudaliar S, Hawkins M, Kurpad AV, Pahwa D, Yadav AK, Sharma RR, Jha V, Marwaha N, Bhansali S, Bhansali A. Autologous bone marrow-derived mononuclear cells transplantation in type 2 diabetes mellitus: effect on beta-cell function and insulin sensitivity. Diabetol Metab Syndr. 2017 Jul 4;9:50. doi: 10.1186/s13098-017-0248-7. eCollection 2017.
Results Reference
derived

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Bone Marrow Derived Stem Cell Transplantation in T2DM

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