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| Name | Class |
|---|---|
| Translational Medicine Research Collaboration | OTHER |
| British Heart Foundation | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Administration of Intra-dermal SPIO | Experimental | MRI scanning before and after intra-dermal injection of SPIO. |
|
| Mantoux, Venesection, Labelled cells | Experimental | Mantoux test then MRI scanning before and after administration of iron-labelled cells obtained by venesection. |
|
| Mantoux, Apheresis, Labelled cells | Experimental | Mantoux test then MRI scanning before and after administration of iron-labelled cells obtained by apheresis. |
|
| Mantoux, Administration of Endorem | Experimental | Mantoux test then MRI scanning before and after administration of Endorem. |
|
| Mantoux only | Experimental | Mantoux test then serial MRI scanning. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Administration of intra-dermal Endorem | Drug | single dose, intradermal |
|
| 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 |
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| Name | Affiliation | Role |
|---|---|---|
| Jenny M Richards, MBChB MRCS | University of Edinburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Edinburgh / Royal Infirmary of Edinburgh | Edinburgh | Scotland | EH16SU4 | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22787016 | Derived | 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. |
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| Mantoux test | Biological | single dose, intradermal |
|
| Autologous Endorem-labelled mononuclear cells | Biological | single dose, intravenous |
|
| Administration of Endorem | Drug | single dose, intravenous |
|