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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:
ClinicalTrials.gov Identifier:
NCT01169935
First Posted: July 26, 2010
Last Update Posted: February 5, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Translational Medicine Research Collaboration
British Heart Foundation
Information provided by (Responsible Party):
University of Edinburgh
  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: None (Open Label)
Primary Purpose: Diagnostic
Official Title: In Vivo Tracking of Magnetically-labelled Human Mononuclear Cells Using MRI Scanning

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, 3 - 5 days ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Edinburgh
ClinicalTrials.gov Identifier: NCT01169935     History of Changes
Other Study ID Numbers: 10/S1102/31
First Submitted: July 23, 2010
First Posted: July 26, 2010
Last Update Posted: February 5, 2013
Last Verified: February 2013

Keywords provided by University of Edinburgh:
MRI
SPIO
Healthy Volunteer