The Use of Magnetic Resonance Imaging and Superparamagnetic Particles of Iron Oxide in Cardiovascular Disease - a Pilot Study in Healthy Volunteers
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Edinburgh
- Enrollment
- 12
- Locations
- 1
- Primary Endpoint
- Change in signal intensity in the region of interest on MRI scanning
Study Overview
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:
- Assess the feasibility of imaging Endorem-labelled cells in vivo
- Compare the distribution of Endorem-labelled cells with that of intravenous injection of Endorem
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- 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
Arms & Interventions
Administration of labelled cells
MRI scanning before and after administration of iron-labelled cells
Intervention: Administration of autologous Endorem-labelled mononuclear cells intravenously (Biological)
Administration of Endorem
MRI scanning before and after intravenous administration of Endorem
Intervention: Administration of Endorem (Drug)
Outcomes
Primary Outcomes
Change in signal intensity in the region of interest on MRI scanning
Time Frame: 0 hours, 24 hours, 48 hours, 5-7 days
Secondary Outcomes
No secondary outcomes reported