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Completed

NCT Number: NCT01065298

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

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

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Key information

Age range

30 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Post Graduate Institute of Medical Education and Research

Chandigarh, Chandigarh UT, India

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Patients with T1DM 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/ cholelitiasis/ cholecystectomy
  • Seropositivity for HIV, HBsAg and HCV.
  • History of myocardial infarction or unstable angina in the previous 3 months.
  • History of malignancy
  • Patients with active infections.

Treatment and study plan

Stem Cell Transplantation

Biological

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 .

Other names: Autologous Bone marrow derived stem cell transplantation

Primary outcomes

  1. 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 outcomes

  1. Any reduction in requirement of insulin dosage and any improvement of HbA1c levels as compared to controls.

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Post Graduate Institute of Medical Education and Research, Chandigarh

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Feb 9, 2010
Registry last updated
Oct 21, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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