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

Not Applicable

Completed

• Conditions: Healthy Volunteer
• Interventions: Drug: Administration of Endorem; Biological: Administration of autologous Endorem-labelled mononuclear cells intravenously

• Registration Number: NCT00972946
• Lead Sponsor: University of Edinburgh

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

Detailed Description

Not available

Study Timeline

• Study Start: 2009-09
• Study First Submitted: 2009-09-07
• Study First Submitted QC: 2009-09-08
• Study First Posted: 2009-09-09
• Primary Completion: 2012-01-06
• Study Completion: 2012-01-06
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-10
• Last Update Posted: 2021-06-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Administration of Endorem	Administration of Endorem	MRI scanning before and after intravenous administration of Endorem
Administration of labelled cells	Administration of autologous Endorem-labelled mononuclear cells intravenously	MRI scanning before and after administration of iron-labelled cells

Primary Outcome Measures

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

Trial Locations

Locations (1)

University of Edinburgh/Royal Infirmary of Edinburgh; 🇬🇧 Edinburgh, United Kingdom