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Completed

NCT Number: NCT01169935

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

Treatment of a wide range of diseases using stem cells and other types of cell appears promising. Following administration of cells it is often not clear where exactly the cells have gone and how many of them have reached the target site. This has been one of the challenges of developing these treatment options further. We have developed a method of labelling human cells with a magnetic resonance imaging (MRI) "contrast agent" which contains tiny iron filings. Following intravenous administration it is possible to see where the iron-labelled cells have gone using MRI scanning. We would like to do is to demonstrate that these cells behave normally and migrate to a site of inflammation. We plan to induce an area of inflammation in the forearm of healthy volunteers using the Mantoux test (a test of immunity against tuberculosis) before giving the labelled cells intravenously. After the Mantoux test we will give these volunteers iron-labelled cells and do MRI scans of their forearm to determine whether these cells can be seen accumulating in the target site.

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Key information

Conditions

Healthy

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Edinburgh / Royal Infirmary of Edinburgh

Edinburgh, Scotland, EH16SU4, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy male or female volunteers age 18 to 65 years
  • Previous vaccine for tuberculosis more than 5 years ago

Exclusion criteria

  • pregnancy / breast feeding
  • Contra-indication to MRI scanning
  • Inability or refusal to give informed consent
  • Renal failure (eGFR <25mL/min) or hepatic dysfunction (Child's B or C)
  • HIV/hepatitis B/hepatitis C/HTLV/syphilis
  • Active malignant disease
  • Anaemia
  • Blood dyscrasia
  • High risk of allergy to protamine sulphate (fish allergy, infertile men, vasectomy)
  • Known history of tuberculosis infection.
  • History of prolonged residence (> 6 months) in a region or country with a high prevalence of tuberculosis.
  • Previous Mantoux reaction of 15mm of greater.

Treatment and study plan

Administration of intra-dermal Endorem

Drug

single dose, intradermal

Mantoux test

Biological

single dose, intradermal

Autologous Endorem-labelled mononuclear cells

Biological

single dose, intravenous

Administration of Endorem

Drug

single dose, intravenous

Primary outcomes

  1. Change in signal intensity in the region of interest on MRI scanning

    Time frame: 0 hours, 24 hours, 48 hours, 3 - 5 days

Sponsors and collaborators

Lead sponsor

University of Edinburgh

Other

Collaborators

  • British Heart Foundation
  • Translational Medicine Research Collaboration

Registry information

Official study title

In Vivo Tracking of Magnetically-labelled Human Mononuclear Cells Using MRI Scanning

Important dates

Study start
2010
Primary completion
2011
First posted
Jul 26, 2010
Registry last updated
Feb 5, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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