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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2009 by Postgraduate Institute of Medical Education and Research.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Postgraduate Institute of Medical Education and Research
ClinicalTrials.gov Identifier:
NCT01065298
First received: February 8, 2010
Last updated: February 10, 2010
Last verified: November 2009
  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 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Any reduction in requirement of insulin dosage and any improvement of HbA1c levels as compared to controls. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: November 2009
Estimated Study Completion Date: July 2011
Estimated 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

Ages Eligible for Study:   30 Years to 75 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01065298

Contacts
Contact: Anil Bhansali, MD.,DM 2756583 ext 0172 anilbhansali_endocrine@rediffmail.com
Contact: Prem kumar, MD 09872308780 prem.kkumar@rediffmail.com

Locations
India
Post Graduate Institute of Medical Education and Research Recruiting
Chandigarh, Chandigarh UT, India
Principal Investigator: Prem Kumar, MD         
Sub-Investigator: Shobhit Bhansali, Msc         
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, PIMERindia
ClinicalTrials.gov Identifier: NCT01065298     History of Changes
Other Study ID Numbers: ABMSCT2
Study First Received: February 8, 2010
Last Updated: February 10, 2010
Health Authority: India: Indian Council of Medical Research

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on August 19, 2014