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

This study has been completed.
Sponsor:
Collaborators:
Translational Medicine Research Collaboration
British Heart Foundation
Information provided by (Responsible Party):
University of Edinburgh
ClinicalTrials.gov Identifier:
NCT01169935
First received: July 23, 2010
Last updated: February 4, 2013
Last verified: February 2013
History of Changes

July 23, 2010
February 4, 2013
July 2010
April 2011   (final data collection date for primary outcome measure)
Change in signal intensity in the region of interest on MRI scanning [ Time Frame: 0 hours, 24 hours, 48 hours, 3 - 5 days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01169935 on ClinicalTrials.gov Archive Site
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Tracking Inflammatory Cells Using Superparamagnetic Particles of Iron Oxide (SPIO) and Magnetic Resonance Imaging (MRI)
In Vivo Tracking of Magnetically-labelled Human Mononuclear Cells Using MRI Scanning

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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Interventional
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Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Healthy
  • Drug: Administration of intra-dermal Endorem
    single dose, intradermal
  • Biological: Mantoux test
    single dose, intradermal
  • Biological: Autologous Endorem-labelled mononuclear cells
    single dose, intravenous
  • Drug: Administration of Endorem
    single dose, intravenous
  • Experimental: Administration of Intra-dermal SPIO
    MRI scanning before and after intra-dermal injection of SPIO.
    Intervention: Drug: Administration of intra-dermal Endorem
  • Experimental: Mantoux, Venesection, Labelled cells
    Mantoux test then MRI scanning before and after administration of iron-labelled cells obtained by venesection.
    Interventions:
    • Biological: Mantoux test
    • Biological: Autologous Endorem-labelled mononuclear cells
  • Experimental: Mantoux, Apheresis, Labelled cells
    Mantoux test then MRI scanning before and after administration of iron-labelled cells obtained by apheresis.
    Interventions:
    • Biological: Mantoux test
    • Biological: Autologous Endorem-labelled mononuclear cells
  • Experimental: Mantoux, Administration of Endorem
    Mantoux test then MRI scanning before and after administration of Endorem.
    Interventions:
    • Biological: Mantoux test
    • Drug: Administration of Endorem
  • Experimental: Mantoux only
    Mantoux test then serial MRI scanning.
    Intervention: Biological: Mantoux test
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
12
Not Provided
April 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT01169935
10/S1102/31
No
University of Edinburgh
University of Edinburgh
  • Translational Medicine Research Collaboration
  • British Heart Foundation
Principal Investigator: Jenny M Richards, MBChB MRCS University of Edinburgh
University of Edinburgh
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP