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

U

University of Edinburgh

Status

Completed

Conditions

Healthy Volunteer

Treatments

Biological: Administration of autologous Endorem-labelled mononuclear cells intravenously
Drug: Administration of Endorem

Study type

Interventional

Funder types

Other

Identifiers

NCT00972946
2007/R/CAR/15.2

Details and patient eligibility

About

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

Enrollment

12 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Diagnostic

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

12 participants in 2 patient groups

Administration of labelled cells
Experimental group
Description:
MRI scanning before and after administration of iron-labelled cells
Treatment:
Biological: Administration of autologous Endorem-labelled mononuclear cells intravenously
Administration of Endorem
Experimental group
Description:
MRI scanning before and after intravenous administration of Endorem
Treatment:
Drug: Administration of Endorem

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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