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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01065298
First Posted: February 9, 2010
Last Update Posted: October 21, 2015
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.
Information provided by (Responsible Party):
Anil Bhansali, Postgraduate Institute of Medical Education and Research
  Purpose
The purpose of this study is to improve blood glucose control in Type 2 Diabetes mellitus patients.

Condition Intervention Phase
Type 2 Diabetes Mellitus Biological: stem cell transplantation Phase 2 Phase 3

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Efficacy Of Autologous Bone Marrow Derived Stem Cell Transplantation In Patients With Type 2 Diabetes Mellitus

Resource links provided by NLM:


Further study details as provided by Anil Bhansali, Postgraduate Institute of Medical Education and Research:

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

Enrollment: 30
Study Start Date: November 2009
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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
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 .
Other Name: Autologous Bone marrow derived stem cell transplantation
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.

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.
  Eligibility

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Ages Eligible for Study:   30 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with type 2 Diabetes mellitus with triple Oral hypoglycemic failure and on Insulin for glycemic control
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01065298


Locations
India
Post Graduate Institute of Medical Education and Research
Chandigarh, Chandigarh UT, India
Sponsors and Collaborators
Postgraduate Institute of Medical Education and Research
Investigators
Study Chair: Anil Bhansali, MD.,DM Postgraduate Institute of Medical Education and Research
Principal Investigator: Neelam Marwaha, MD.,DM Postgraduate Institute of Medical Education and Research
Principal Investigator: N Khandelwal, MD Postgraduate Institute of Medical Education and Research
Principal Investigator: B.R. Mittal, MD Postgraduate Institute of Medical Education and Research
Principal Investigator: Prem Kumar, MD Postgraduate Institute of Medical Education and Research
Principal Investigator: Rama Walia, MD.,DM Postgraduate Institute of Medical Education and Research
  More Information

Publications:
Responsible Party: Anil Bhansali, head of department, Postgraduate Institute of Medical Education and Research
ClinicalTrials.gov Identifier: NCT01065298     History of Changes
Other Study ID Numbers: ABMSCT2
First Submitted: February 8, 2010
First Posted: February 9, 2010
Last Update Posted: October 21, 2015
Last Verified: October 2015

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs