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

Healthy Volunteer Clinical Trial

Official title:

The Use of Magnetic Resonance Imaging and Superparamagnetic Particles of Iron Oxide in Cardiovascular Disease - a Pilot Study in Healthy Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00972946
• Other study ID #: 2007/R/CAR/15.2
• Status: Completed
• Phase: N/A
• Start date: September 2009
• Est. completion date: January 6, 2012

Study information

• Verified date: June 2021
• Source: University of Edinburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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. Assess the feasibility of imaging Endorem-labelled cells in vivo

2. Compare the distribution of Endorem-labelled cells with that of intravenous injection of Endorem

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: January 6, 2012
• Est. primary completion date: January 6, 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Healthy volunteers

• Age >18 years

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Healthy Volunteer

Intervention

Biological:
• Administration of autologous Endorem-labelled mononuclear cells intravenously
single dose

Drug:
• Administration of Endorem
single dose, intravenous

Locations

Country	Name	City	State
United Kingdom	University of Edinburgh/Royal Infirmary of Edinburgh	Edinburgh

Sponsors (3)

Lead Sponsor	Collaborator
University of Edinburgh	Royal College of Surgeons of Edinburgh, Translational Medicine Research Collaboration

Country where clinical trial is conducted

United Kingdom, 

References & 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, B — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in signal intensity in the region of interest on MRI scanning		0 hours, 24 hours, 48 hours, 5-7 days