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

Study Overview
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Brief Summary
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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.

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

Conditions
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Healthy

Intervention / Treatment
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* Drug: Administration of intra-dermal Endorem
* Biological: Mantoux test
* Biological: Autologous Endorem-labelled mononuclear cells
* Drug: Administration of Endorem


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Administration of Intra-dermal SPIO<br>MRI scanning before and after intra-dermal injection of SPIO. | Drug: Administration of intra-dermal Endorem<br>* single dose, intradermal<br>|
| Experimental: Mantoux, Venesection, Labelled cells<br>Mantoux test then MRI scanning before and after administration of iron-labelled cells obtained by venesection. | Biological: Mantoux test<br>* single dose, intradermal<br>Biological: Autologous Endorem-labelled mononuclear cells<br>* single dose, intravenous<br>|
| Experimental: Mantoux, Apheresis, Labelled cells<br>Mantoux test then MRI scanning before and after administration of iron-labelled cells obtained by apheresis. | Biological: Mantoux test<br>* single dose, intradermal<br>Biological: Autologous Endorem-labelled mononuclear cells<br>* single dose, intravenous<br>|
| Experimental: Mantoux, Administration of Endorem<br>Mantoux test then MRI scanning before and after administration of Endorem. | Biological: Mantoux test<br>* single dose, intradermal<br>Drug: Administration of Endorem<br>* single dose, intravenous<br>|
| Experimental: Mantoux only<br>Mantoux test then serial MRI scanning. | Biological: Mantoux test<br>* single dose, intradermal<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in signal intensity in the region of interest on MRI scanning |  | 0 hours, 24 hours, 48 hours, 3 - 5 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MRI, SPIO, Healthy Volunteer