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

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:

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

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)

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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