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

University of Edinburgh

Status: Completed

Conditions: Healthy

Treatments: Biological: Mantoux test; Drug: Administration of intra-dermal Endorem; Drug: Administration of Endorem; Biological: Autologous Endorem-labelled mononuclear cells

Study type: Interventional

Funder types: Other

Identifiers

NCT01169935

10/S1102/31

Details and patient eligibility

About

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.

Enrollment: 12 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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12 participants in 5 patient groups

Administration of Intra-dermal SPIO

Experimental group

Description:

MRI scanning before and after intra-dermal injection of SPIO.

Treatment:

Drug: Administration of intra-dermal Endorem

Mantoux, Venesection, Labelled cells

Experimental group

Description:

Mantoux test then MRI scanning before and after administration of iron-labelled cells obtained by venesection.

Treatment:

Biological: Autologous Endorem-labelled mononuclear cells

Biological: Mantoux test

Mantoux, Apheresis, Labelled cells

Experimental group

Description:

Mantoux test then MRI scanning before and after administration of iron-labelled cells obtained by apheresis.

Treatment:

Biological: Autologous Endorem-labelled mononuclear cells

Biological: Mantoux test

Mantoux, Administration of Endorem

Experimental group

Description:

Mantoux test then MRI scanning before and after administration of Endorem.

Treatment:

Drug: Administration of Endorem

Biological: Mantoux test

Mantoux only

Experimental group

Description:

Mantoux test then serial MRI scanning.

Treatment:

Biological: Mantoux test