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

NCT01065298 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 30

Last updated 2015-10-21

No results posted yet for this study

Summary

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

Conditions

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 .

Sponsors & Collaborators

  • Post Graduate Institute of Medical Education and Research, Chandigarh

    lead OTHER

Principal Investigators

  • Anil Bhansali, MD.,DM · Post Graduate Institute of Medical Education and Research, Chandigarh

  • Neelam Marwaha, MD.,DM · Post Graduate Institute of Medical Education and Research, Chandigarh

  • N Khandelwal, MD · Post Graduate Institute of Medical Education and Research, Chandigarh

  • B.R. Mittal, MD · Post Graduate Institute of Medical Education and Research, Chandigarh

  • Prem Kumar, MD · Post Graduate Institute of Medical Education and Research, Chandigarh

  • Rama Walia, MD.,DM · Post Graduate Institute of Medical Education and Research, Chandigarh

Eligibility

Min Age
30 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-11-30
Primary Completion
2011-07-31
Completion
2011-07-31

Countries

  • India

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01065298 on ClinicalTrials.gov