Tissue Distribution of F18-FDG Labelled Autologous Bone Marrow Derived Stem Cells in Patients With Type 2 DM

September 28, 2012 updated by: Dr Vikas Sood, Postgraduate Institute of Medical Education and Research

Tissue Distribution of F18-FDG Labelled Autologous Bone Marrow Derived Stem Cells in Patients With Type 2 Diabetes Mellitus

Investigators purpose is to track stem cells in vivo in the type 2 diabetes mellitus patients after the same have been labelled with positron emission tomography tracer F18-FDG; as it is assumed that the therapeutic outcome will profoundly depend on the delivery of these cells to pancreas. Biodistribution and quantification studies will be done at 30 minutes and 90 minutes of stem cell infusion.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Autologous bone marrow derived stem cells have a promising potential in regenerative medicine. In particular the past decade has garnered a great interest in cellular therapy for treating Type2 diabetes mellitus. The pertinent questions in regenerative medicine today are to know about the homing, survival, differentiation and functionality of the cells and based on these to find out the adequate administration methods and choose the optimal dose and cell types. Various modalities have been used in the preclinical and clinical trials. These include MRI,optical imaging in the form of bioluminescence and fluorescence, quantum dots, SPECT and PET/CT imaging. However the methods which are suitable for stem cell tracking in small animals are not easily translated for human trials. In humans PET/CT imaging with its reasonable resolution and unique ability to combine anatomical and functional imaging is considered to be the best bet yet. Hence we intend to label the autologous bone marrow derived stem cells with PET tracer F18-FDG and carry out biodistribution studies, our ultimate aim being to study how in vivo distribution of the cells affect therapeutic efficacy.

Study Type

Interventional

Enrollment (Anticipated)

28

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with T2DM between 30 and 70 years of age.
  • Failure to triple OHA and on stable doses of insulin for at least 3 months.
  • On vildagliptin, pioglitazone and metformin for at least 3 months along with Insulin to maintain euglycemia.
  • HbA1c of 6.5-7.5%
  • Insulin requirement ≥0.4 IU/kg/d.
  • Glutamic acid decarboxylase (GAD 65) 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 pancreatitis
  • 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.
  • Female patients who are pregnant or lactating

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Stem cell therapy - SPD artery
Stem cells will be infused into the superior pancreaticoduodenal artery.
Other: Stem cell therapy- SPD artery
A total of 28 patients will be enrolled and randomized to four groups of 7 patients each. 7 patients will receive stem cell infusion into the superior pancreaticoduodenal artery. Another 7 patients will be given stem cell infusion into the splenic artery. The next batch of 7 patients will receive stem cell infusion from the peripheral intravenous route and 7 patients will act as controls undergoing a sham procedure with infusion of normal saline.
Other Names:
  • Autologous bone marrow derived stem cells
  • Bone marrow mononuclear cells
Active Comparator: Stem cell therapy - splenic artery
Stem cells will be infused into the splenic artery.
Other: Stem cell therapy- splenic artery
7 patients will receive stem cells infusion through splenic artery.
Active Comparator: Stem cell therapy-intravenous
Stem cells will be given intravenously.
Other: Stem cell therapy-intravenous
7 patients will receive stem cells infusion through peripheral intravenous route.
Placebo Comparator: Normal saline placebo -sham procedure
Sham procedure with infusion of normal saline.
Other: Normal saline placebo -sham procedure
7 patients will receive infusion of normal saline and will act as control groups

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
• Increment in glucagon stimulated C - peptide levels at the end of 6 months of ABMSCT, as compared to baseline
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
• Any reduction in requirement of insulin dosage measured as a percentage decrease from baseline • Improvement of HbA1c levels as compared to baseline
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Postgraduate Institute of Medical Education and Research

Collaborators

Indian Council of Medical Research

Investigators

  • Principal Investigator: Bhagwant R Mittal, MBBS,DRM,MD, Post Graduate Institute of Medical education and Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2010

Primary Completion (Actual)

August 1, 2012

Study Completion (Anticipated)

February 1, 2013

Study Registration Dates

First Submitted

September 24, 2012

First Submitted That Met QC Criteria

September 24, 2012

First Posted (Estimate)

September 27, 2012

Study Record Updates

Last Update Posted (Estimate)

October 1, 2012

Last Update Submitted That Met QC Criteria

September 28, 2012

Last Verified

September 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STEM CELL PGI

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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