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

NCT01694173 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2012-10-01

No results posted yet for this study

Summary

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.

Conditions

Interventions

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

Stem cell therapy- splenic artery

7 patients will receive stem cells infusion through splenic artery.

OTHER

Stem cell therapy-intravenous

7 patients will receive stem cells infusion through peripheral intravenous route.

OTHER

Normal saline placebo -sham procedure

7 patients will receive infusion of normal saline and will act as control groups

Sponsors & Collaborators

  • Indian Council of Medical Research

    collaborator OTHER_GOV

  • Post Graduate Institute of Medical Education and Research, Chandigarh

    lead OTHER

Principal Investigators

  • Bhagwant R Mittal, MBBS,DRM,MD · Post Graduate Institute of Medical Education and Research, Chandigarh

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2010-12-31
Primary Completion
2012-08-31
Completion
2013-02-28

Countries

  • India

Study Locations

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Entities

Diseases

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 NCT01694173 on ClinicalTrials.gov