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Cell Tracking Using Superparamagnetic Particles of Iron Oxide (SPIO) and Magnetic Resonance Imaging (MRI) - A Pilot Study

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.
ClinicalTrials.gov Identifier: NCT00972946
Recruitment Status : Unknown
Verified September 2009 by University of Edinburgh.
Recruitment status was:  Recruiting
First Posted : September 9, 2009
Last Update Posted : September 9, 2009
Information provided by:

Study Description
Brief Summary:

The ability to label specific cells and image their natural movements in vivo would allow researchers to investigate the mechanisms of disease progression. In addition, cell-based therapy, especially stem cell therapy, requires non-invasive monitoring of transplanted cells to follow their bio-distribution and biological function. Because of recent interest in stem cell treatment, several methods have been investigated for in vivo cell tracking. The investigators propose to assess whether the magnetic resonance imaging (MRI) contrast agent Endorem (superparamagnetic particles of iron oxide) can be used to label cells for in vivo tracking using MRI. The investigators will use 20 healthy human volunteers to:

  1. Assess the feasibility of imaging Endorem-labelled cells in vivo
  2. Compare the distribution of Endorem-labelled cells with that of intravenous injection of Endorem

Condition or disease Intervention/treatment
Healthy Volunteer Biological: Administration of autologous Endorem-labelled mononuclear cells intravenously Drug: Administration of Endorem

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: The Use of Magnetic Resonance Imaging and Superparamagnetic Particles of Iron Oxide in Cardiovascular Disease - a Pilot Study in Healthy Volunteers
Study Start Date : September 2009
Estimated Primary Completion Date : September 2011
Estimated Study Completion Date : September 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Iron MRI Scans
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Administration of labelled cells
MRI scanning before and after administration of iron-labelled cells
Biological: Administration of autologous Endorem-labelled mononuclear cells intravenously
single dose
Experimental: Administration of Endorem
MRI scanning before and after intravenous administration of Endorem
Drug: Administration of Endorem
single dose, intravenous

Outcome Measures

Primary Outcome Measures :
  1. Change in signal intensity in the region of interest on MRI scanning [ Time Frame: 0 hours, 24 hours, 48 hours, 5-7 days ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Healthy volunteers
  • Age >18 years

Exclusion Criteria:

  • Pregnancy
  • Contraindication to MRI scanning (detected by safety questionnaire) including severe claustrophobia
  • Inability or refusal to give informed consent
  • Renal or hepatic dysfunction
  • HIV/hepatitis B/ hepatitis C/ HTLV/ syphilis
  • Intercurrent illness
  • Blood dyscrasias
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): NCT00972946

Contact: Jennifer MJ Richards, MBChB BSc MRCS 0131 242 3621 jenny.richards@ed.ac.uk
Contact: David E Newby 0131 242 6515 d.e.newby@ed.ac.uk

United Kingdom
University of Edinburgh/Royal Infirmary of Edinburgh Recruiting
Edinburgh, United Kingdom, EH16 4SA
Sponsors and Collaborators
University of Edinburgh
Royal College of Surgeons of Edinburgh
Translational Medicine Research Collaboration
Principal Investigator: David E Newby University of Edinburgh