NCT01169935

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2010

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

July 23, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 26, 2010

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed
Last Updated

February 5, 2013

Status Verified

February 1, 2013

Enrollment Period

9 months

First QC Date

July 23, 2010

Last Update Submit

February 4, 2013

Conditions

Healthy

Keywords

MRISPIOHealthy Volunteer

Outcome Measures

Primary Outcomes (1)

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

    0 hours, 24 hours, 48 hours, 3 - 5 days

Study Arms (5)

Administration of Intra-dermal SPIO

EXPERIMENTAL

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

Drug: Administration of intra-dermal Endorem

Mantoux, Venesection, Labelled cells

EXPERIMENTAL

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

Biological: Mantoux testBiological: Autologous Endorem-labelled mononuclear cells

Mantoux, Apheresis, Labelled cells

EXPERIMENTAL

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

Biological: Mantoux testBiological: Autologous Endorem-labelled mononuclear cells

Mantoux, Administration of Endorem

EXPERIMENTAL

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

Biological: Mantoux testDrug: Administration of Endorem

Mantoux only

EXPERIMENTAL

Mantoux test then serial MRI scanning.

Biological: Mantoux test

Interventions

Administration of intra-dermal EndoremDRUG

single dose, intradermal

Administration of Intra-dermal SPIO
Mantoux testBIOLOGICAL

single dose, intradermal

Mantoux onlyMantoux, Administration of EndoremMantoux, Apheresis, Labelled cellsMantoux, Venesection, Labelled cells
Autologous Endorem-labelled mononuclear cellsBIOLOGICAL

single dose, intravenous

Mantoux, Apheresis, Labelled cellsMantoux, Venesection, Labelled cells
Administration of EndoremDRUG

single dose, intravenous

Mantoux, Administration of Endorem

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy male or female volunteers age 18 to 65 years
  • Previous vaccine for tuberculosis more than 5 years ago

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Edinburgh / Royal Infirmary of Edinburgh

Edinburgh, Scotland, EH16SU4, 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: 22787016DERIVED

Study Officials

  • Jenny M Richards, MBChB MRCS

    University of Edinburgh

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

July 23, 2010

First Posted

July 26, 2010

Study Start

July 1, 2010

Primary Completion

April 1, 2011

Last Updated

February 5, 2013

Record last verified: 2013-02

Locations

GB(1)