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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2012-01-06

Brief Summary

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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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Detailed Description

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Conditions

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Healthy Volunteer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Administration of labelled cells

MRI scanning before and after administration of iron-labelled cells

Group Type EXPERIMENTAL

Administration of autologous Endorem-labelled mononuclear cells intravenously

Intervention Type BIOLOGICAL

single dose

Administration of Endorem

MRI scanning before and after intravenous administration of Endorem

Group Type EXPERIMENTAL

Administration of Endorem

Intervention Type DRUG

single dose, intravenous

Interventions

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Administration of autologous Endorem-labelled mononuclear cells intravenously

single dose

Intervention Type BIOLOGICAL

Administration of Endorem

single dose, intravenous

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes