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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00972946

Enrollment

Registered

2009-09-09

Start date

2009-09-30

Completion date

2012-01-06

Last updated

2021-06-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteer

Keywords

MRI, SPIO

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: 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

Interventions

BIOLOGICALAdministration of autologous Endorem-labelled mononuclear cells intravenously

single dose

DRUGAdministration of Endorem

single dose, intravenous

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Change in signal intensity in the region of interest on MRI scanning	0 hours, 24 hours, 48 hours, 5-7 days

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 26, 2026