Efficacy Of Autologous Bone Marrow Derived Stem Cell Transplantation In Patients With Type 2 Diabetes Mellitus-2

Overview

The purpose of this study is to improve blood glucose control in Type 2 Diabetes mellitus patients.

Full Title of Study: “Efficacy Of Autologous Bone Marrow Derived Stem Cell Transplantation In Patients With Type 2 Diabetes Mellitus”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: July 2011

Detailed Description

We hypothesize that Autologous bone marrow derived stem cell transplantation(ABMSCT)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 ABMSCT 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 microenvironment which supports beta cell/resident stem cell activation and survival.

Interventions

  • Biological: stem cell transplantation
    • Group 1: 200 – 250 ml of bone marrow will be aspirated and layered on density gradient medium (Ficoll – Hyperaque) and stem cells will be separated. Separated MNC’s will be tagged with FDG-PET and injected into superior pancreatico duodenal artery and an PET scan will be done 2 hours later to see the percentage of stem cells homing in to pancreas. After 8 weeks G-CSF(10mcg/Kg/day) will be given subcutaneous for 5 days to achieve a Leucocyte count of >40,000/mm3. Patients will be urged to monitor and document blood glucose readings for next 6 months. Glucagon stimulated C – peptide, plasma Insulin, HOMA-IR , HOMA-B ,HbA1c, lipid profile and biochemistry will be done at baseline and 6 months .

Arms, Groups and Cohorts

  • Group 1:Stem cell Recipient
    • Patients with Type 2 Diabetes mellitus on full doses of Vildagliptin+Pioglitazone+Metformin and requiring Insulin at dose of >0.4U/Kg for blood glucose control. They will undergo stem cell therapy initialy and G-CSF therapy at 2 months
  • Group-2: Controls
    • Type 2 Diabetes mellitus patients on full doses of vildagliptin+metformin+pioglitazone and on Insulin >0.4U/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.

Clinical Trial Outcome Measures

Primary Measures

  • Reduction of insulin requirement by ≥ 50% by the end of 6 months of ABMSCT and Improvement in Glucagon stimulated C – peptide levels .
    • Time Frame: 6 months

Secondary Measures

  • Any reduction in requirement of insulin dosage and any improvement of HbA1c levels as compared to controls.
    • Time Frame: 6 months

Participating in This Clinical Trial

Inclusion Criteria

1. Patients with type 2 diabetes mellitus between 30 and 70 years of age. 2. Failure to triple OHA and on stable doses of insulin for atleast 3 months. 3. On vildagliptin,pioglitazone and metformin for atleast 3 months along with Insulin to maintain euglycemia. 4. HbA1c < 8.5%. 5. Insulin requirement ≥0.4 IU/kg/d. 6. GAD antibody negative status. Exclusion Criteria:

1. Patients with T1DM or secondary diabetes. 2. Patients with serum creatinine > 1.5 mg/dl. 3. 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). 4. History of cholecystitis/ cholelitiasis/ cholecystectomy 5. Seropositivity for HIV, HBsAg and HCV. 6. History of myocardial infarction or unstable angina in the previous 3 months. 7. History of malignancy 8. Patients with active infections.

Gender Eligibility: All

Minimum Age: 30 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Post Graduate Institute of Medical Education and Research, Chandigarh
  • Provider of Information About this Clinical Study
    • Principal Investigator: Anil Bhansali, head of department – Post Graduate Institute of Medical Education and Research, Chandigarh
  • Overall Official(s)
    • Anil Bhansali, MD.,DM, Study Chair, Post Graduate Institute of Medical Education and Research, Chandigarh
    • Neelam Marwaha, MD.,DM, Principal Investigator, Post Graduate Institute of Medical Education and Research, Chandigarh
    • N Khandelwal, MD, Principal Investigator, Post Graduate Institute of Medical Education and Research, Chandigarh
    • B.R. Mittal, MD, Principal Investigator, Post Graduate Institute of Medical Education and Research, Chandigarh
    • Prem Kumar, MD, Principal Investigator, Post Graduate Institute of Medical Education and Research, Chandigarh
    • Rama Walia, MD.,DM, Principal Investigator, Post Graduate Institute of Medical Education and Research, Chandigarh

Citations Reporting on Results

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.

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