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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2009 by University of Edinburgh.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Royal College of Surgeons of Edinburgh
Translational Medicine Research Collaboration
Information provided by:
University of Edinburgh
ClinicalTrials.gov Identifier:
NCT00972946
First received: September 7, 2009
Last updated: September 8, 2009
Last verified: September 2009
  Purpose

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

Condition Intervention
Healthy Volunteer
Biological: Administration of autologous Endorem-labelled mononuclear cells intravenously
Drug: Administration of Endorem

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: The Use of Magnetic Resonance Imaging and Superparamagnetic Particles of Iron Oxide in Cardiovascular Disease - a Pilot Study in Healthy Volunteers

Resource links provided by NLM:


Further study details as provided by University of Edinburgh:

Primary Outcome Measures:
  • Change in signal intensity in the region of interest on MRI scanning [ Time Frame: 0 hours, 24 hours, 48 hours, 5-7 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: September 2009
Estimated Study Completion Date: September 2011
Estimated Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Administration of labelled cells
MRI scanning before and after administration of iron-labelled cells
Biological: Administration of autologous Endorem-labelled mononuclear cells intravenously
single dose
Experimental: Administration of Endorem
MRI scanning before and after intravenous administration of Endorem
Drug: Administration of Endorem
single dose, intravenous

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00972946

Contacts
Contact: Jennifer MJ Richards, MBChB BSc MRCS 0131 242 3621 jenny.richards@ed.ac.uk
Contact: David E Newby 0131 242 6515 d.e.newby@ed.ac.uk

Locations
United Kingdom
University of Edinburgh/Royal Infirmary of Edinburgh Recruiting
Edinburgh, United Kingdom, EH16 4SA
Sponsors and Collaborators
University of Edinburgh
Royal College of Surgeons of Edinburgh
Translational Medicine Research Collaboration
Investigators
Principal Investigator: David E Newby University of Edinburgh
  More Information

No publications provided

Responsible Party: Elspeth Currie, University of Edinburgh
ClinicalTrials.gov Identifier: NCT00972946     History of Changes
Other Study ID Numbers: 2007/R/CAR/15.2
Study First Received: September 7, 2009
Last Updated: September 8, 2009
Health Authority: United Kingdom: none

Keywords provided by University of Edinburgh:
MRI
SPIO

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 20, 2014