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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2009 by University of Edinburgh.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Royal College of Surgeons of Edinburgh
Translational Medicine Research Collaboration
Information provided by:
University of Edinburgh
ClinicalTrials.gov Identifier:
NCT00972946
First received: September 7, 2009
Last updated: September 8, 2009
Last verified: September 2009

September 7, 2009
September 8, 2009
September 2009
September 2011   (final data collection date for primary outcome measure)
Change in signal intensity in the region of interest on MRI scanning [ Time Frame: 0 hours, 24 hours, 48 hours, 5-7 days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00972946 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Cell Tracking Using Superparamagnetic Particles of Iron Oxide (SPIO) and Magnetic Resonance Imaging (MRI) - A Pilot Study
The Use of Magnetic Resonance Imaging and Superparamagnetic Particles of Iron Oxide in Cardiovascular Disease - a Pilot Study in Healthy Volunteers

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
Not Provided
Interventional
Not Provided
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Healthy Volunteer
  • Biological: Administration of autologous Endorem-labelled mononuclear cells intravenously
    single dose
  • Drug: Administration of Endorem
    single dose, intravenous
  • Experimental: Administration of labelled cells
    MRI scanning before and after administration of iron-labelled cells
    Intervention: Biological: Administration of autologous Endorem-labelled mononuclear cells intravenously
  • Experimental: Administration of Endorem
    MRI scanning before and after intravenous administration of Endorem
    Intervention: Drug: Administration of Endorem
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
20
September 2011
September 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
Yes
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
 
NCT00972946
2007/R/CAR/15.2
No
Elspeth Currie, University of Edinburgh
University of Edinburgh
  • Royal College of Surgeons of Edinburgh
  • Translational Medicine Research Collaboration
Principal Investigator: David E Newby University of Edinburgh
University of Edinburgh
September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP