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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
  Purpose

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.


Condition Intervention
Healthy
 Drug: Administration of intra-dermal Endorem
Biological: Mantoux test
Biological: Autologous Endorem-labelled mononuclear cells
Drug: Administration of Endorem

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: In Vivo Tracking of Magnetically-labelled Human Mononuclear Cells Using MRI Scanning

Resource links provided by NLM:

Drug Information available for: Ferumoxides
U.S. FDA Resources

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, 3 - 5 days ] [ Designated as safety issue: No ]

Enrollment: 12
Study Start Date: July 2010
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Administration of Intra-dermal SPIO
MRI scanning before and after intra-dermal injection of SPIO.
 Drug: Administration of intra-dermal Endorem
single dose, intradermal
Experimental: Mantoux, Venesection, Labelled cells
Mantoux test then MRI scanning before and after administration of iron-labelled cells obtained by venesection.
 Biological: Mantoux test
single dose, intradermal
Biological: Autologous Endorem-labelled mononuclear cells
single dose, intravenous
Experimental: Mantoux, Apheresis, Labelled cells
Mantoux test then MRI scanning before and after administration of iron-labelled cells obtained by apheresis.
 Biological: Mantoux test
single dose, intradermal
Biological: Autologous Endorem-labelled mononuclear cells
single dose, intravenous
Experimental: Mantoux, Administration of Endorem
Mantoux test then MRI scanning before and after administration of Endorem.
 Biological: Mantoux test
single dose, intradermal
Drug: Administration of Endorem
single dose, intravenous
Experimental: Mantoux only
Mantoux test then serial MRI scanning.
 Biological: Mantoux test
single dose, intradermal

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01169935

Locations
United Kingdom
University of Edinburgh / Royal Infirmary of Edinburgh
Edinburgh, Scotland, United Kingdom, EH16SU4
Sponsors and Collaborators
University of Edinburgh
Translational Medicine Research Collaboration
British Heart Foundation
Investigators
Principal Investigator: Jenny M Richards, MBChB MRCS University of Edinburgh
  More Information

No publications provided

Responsible Party: University of Edinburgh
ClinicalTrials.gov Identifier: NCT01169935     History of Changes
Other Study ID Numbers: 10/S1102/31
Study First Received: July 23, 2010
Last Updated: February 4, 2013
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by University of Edinburgh:
MRI
SPIO
Healthy Volunteer

ClinicalTrials.gov processed this record on May 16, 2013