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

NCT ID: NCT01169935

Last Updated: 2013-02-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-07-31

Brief Summary

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.

Conditions

Healthy

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Administration of Intra-dermal SPIO

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

Group Type: EXPERIMENTAL

Administration of intra-dermal Endorem

Intervention Type: DRUG

single dose, intradermal

Mantoux, Venesection, Labelled cells

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

Group Type: EXPERIMENTAL

Mantoux test

Intervention Type: BIOLOGICAL

single dose, intradermal

Autologous Endorem-labelled mononuclear cells

Intervention Type: BIOLOGICAL

single dose, intravenous

Mantoux, Apheresis, Labelled cells

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

Group Type: EXPERIMENTAL

Mantoux test

Intervention Type: BIOLOGICAL

single dose, intradermal

Autologous Endorem-labelled mononuclear cells

Intervention Type: BIOLOGICAL

single dose, intravenous

Mantoux, Administration of Endorem

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

Group Type: EXPERIMENTAL

Mantoux test

Intervention Type: BIOLOGICAL

single dose, intradermal

Administration of Endorem

Intervention Type: DRUG

single dose, intravenous

Mantoux only

Mantoux test then serial MRI scanning.

Group Type: EXPERIMENTAL

Mantoux test

Intervention Type: BIOLOGICAL

single dose, intradermal

Interventions

Administration of intra-dermal Endorem

single dose, intradermal

Intervention Type: DRUG

Mantoux test

single dose, intradermal

Intervention Type: BIOLOGICAL

Autologous Endorem-labelled mononuclear cells

single dose, intravenous

Intervention Type: BIOLOGICAL

Administration of Endorem

single dose, intravenous

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Translational Medicine Research Collaboration

OTHER

Sponsor Role: collaborator

British Heart Foundation

OTHER

Sponsor Role: collaborator

University of Edinburgh

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jenny M Richards, MBChB MRCS

Role: PRINCIPAL_INVESTIGATOR

University of Edinburgh

Locations

University of Edinburgh / Royal Infirmary of Edinburgh

Edinburgh, Scotland, United Kingdom

Countries

United Kingdom

References

Richards JM, Shaw CA, Lang NN, Williams MC, Semple SI, MacGillivray TJ, Gray C, Crawford JH, Alam SR, Atkinson AP, Forrest EK, Bienek C, Mills NL, Burdess A, Dhaliwal K, Simpson AJ, Wallace WA, Hill AT, Roddie PH, McKillop G, Connolly TA, Feuerstein GZ, Barclay GR, Turner ML, Newby DE. In vivo mononuclear cell tracking using superparamagnetic particles of iron oxide: feasibility and safety in humans. Circ Cardiovasc Imaging. 2012 Jul;5(4):509-17. doi: 10.1161/CIRCIMAGING.112.972596. Epub 2012 Jul 10.

Reference Type: DERIVED

PMID: 22787016 (View on PubMed)

Other Identifiers

10/S1102/31

Identifier Type: -

Identifier Source: org_study_id