Cell Tracking Using Superparamagnetic Particles of Iron Oxide (SPIO) and Magnetic Resonance Imaging (MRI) - A Pilot Study

NCT00972946 | Completed

• 1 other identifier: 2007/R/CAR/15.2
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

The ability to label specific cells and image their natural movements in vivo would allow researchers to investigate the mechanisms of disease progression. In addition, cell-based therapy, especially stem cell therapy, requires non-invasive monitoring of transplanted cells to follow their bio-distribution and biological function. Because of recent interest in stem cell treatment, several methods have been investigated for in vivo cell tracking. The investigators propose to assess whether the magnetic resonance imaging (MRI) contrast agent Endorem (superparamagnetic particles of iron oxide) can be used to label cells for in vivo tracking using MRI. The investigators will use 20 healthy human volunteers to:

1. 1.Assess the feasibility of imaging Endorem-labelled cells in vivo
2. 2.Compare the distribution of Endorem-labelled cells with that of intravenous injection of Endorem

Conditions

Healthy Volunteer

Keywords

MRI; SPIO

Outcome Measures

Primary Outcomes (1)

• Change in signal intensity in the region of interest on MRI scanning

  0 hours, 24 hours, 48 hours, 5-7 days

Study Arms (2)

Administration of labelled cells

EXPERIMENTAL

MRI scanning before and after administration of iron-labelled cells

Biological: Administration of autologous Endorem-labelled mononuclear cells intravenously

Administration of Endorem

EXPERIMENTAL

MRI scanning before and after intravenous administration of Endorem

Drug: Administration of Endorem

Interventions

Administration of autologous Endorem-labelled mononuclear cells intravenously BIOLOGICAL

single dose

Administration of labelled cells

Administration of Endorem DRUG

single dose, intravenous

Administration of Endorem

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy volunteers
• Age \>18 years

You may not qualify if:

• Pregnancy
• Contraindication to MRI scanning (detected by safety questionnaire) including severe claustrophobia
• Inability or refusal to give informed consent
• Renal or hepatic dysfunction
• HIV/hepatitis B/ hepatitis C/ HTLV/ syphilis
• Intercurrent illness
• Blood dyscrasias

Sponsors & Collaborators

• University of Edinburgh: lead
• Royal College of Surgeons of Edinburgh: collaborator
• Translational Medicine Research Collaboration: collaborator

Study Sites (1)

University of Edinburgh/Royal Infirmary of Edinburgh

Edinburgh, EH16 4SA, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 22787016 RESULT

Study Officials

• David E Newby

  University of Edinburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2009
• First Posted: September 9, 2009
• Study Start: September 1, 2009
• Primary Completion: January 6, 2012
• Study Completion: January 6, 2012
• Last Updated: June 15, 2021

Record last verified: 2021-06

Locations

GB (1)