Bone Marrow Derived Stem Cell Transplantation in T2DM

Phase 2

Completed

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Biological: MNC's TRANSPLANTATION; Other: control; Biological: mesenchymal stem cell transplantation

• Registration Number: NCT01759823
• Lead Sponsor: Post Graduate Institute of Medical Education and Research, Chandigarh

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 Timeline

• Study Start: 2012-12
• Study First Submitted: 2012-12-30
• Study First Submitted QC: 2013-01-02
• Study First Posted: 2013-01-03
• Primary Completion: 2014-12
• Status Verified: 2015-10
• Study Completion: 2015-10
• Last Update Submitted: 2015-10-24
• Last Update Posted: 2015-10-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MNC's TRANSPLANTATION	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.
Control	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
mesenchymal stem cell transplantation	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.

Primary Outcome Measures

Name	Time	Method
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	6 months

Trial Locations

Locations (1)

Postgraduate Institute of Medical Education and Research; 🇮🇳 Chandigarh, UT, India