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Completed

NCT Number: NCT00972946

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

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

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Key information

Conditions

Healthy Volunteer

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Edinburgh/Royal Infirmary of Edinburgh

Edinburgh, EH16 4SA, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Administration of autologous Endorem-labelled mononuclear cells intravenously

Biological

single dose

Administration of Endorem

Drug

single dose, intravenous

Primary outcomes

  1. Change in signal intensity in the region of interest on MRI scanning

    Time frame: 0 hours, 24 hours, 48 hours, 5-7 days

Sponsors and collaborators

Lead sponsor

University of Edinburgh

Other

Collaborators

  • Royal College of Surgeons of Edinburgh
  • Translational Medicine Research Collaboration

Registry information

Official study title

The Use of Magnetic Resonance Imaging and Superparamagnetic Particles of Iron Oxide in Cardiovascular Disease - a Pilot Study in Healthy Volunteers

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Sep 9, 2009
Registry last updated
Jun 15, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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