Healthy VolunteerNCT00972946
Cell Tracking Using Superparamagnetic Particles of Iron Oxide (SPIO) and Magnetic Resonance Imaging (MRI) - A Pilot Study
A study testing Administration of autologous Endorem-labelled mononuclear cells intravenously and Administration of Endorem in people with Healthy Volunteer, run by University of Edinburgh at 1 site in United Kingdom.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer
- What is being tested?
- Administration of autologous Endorem-labelled mononuclear cells intravenously and Administration of Endorem
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2009to 6 Jan 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy volunteers
- Age >18 years
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University of Edinburgh/Royal Infirmary of Edinburgh
Edinburgh, EH16 4SA
About this study
Official title: The Use of Magnetic Resonance Imaging and Superparamagnetic Particles of Iron Oxide in Cardiovascular Disease - a Pilot Study in Healthy Volunteers
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:
- Assess the feasibility of imaging Endorem-labelled cells in vivo
- Compare the distribution of Endorem-labelled cells with that of intravenous injection of Endorem
- Conditions
- Healthy Volunteer
- Being tested
- Administration of autologous Endorem-labelled mononuclear cells intravenously, Administration of Endorem
- Keywords
- MRI, SPIO
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Administration of autologous Endorem-labelled mononuclear cells intravenouslyBiological
single dose
Administration of EndoremDrug
single dose, intravenous
| Study group | Role | What they receive |
|---|---|---|
| Administration of labelled cells | Experimental | MRI scanning before and after administration of iron-labelled cells Receives: Biological: Administration of autologous Endorem-labelled mononuclear cells intravenously |
| Administration of Endorem | Experimental | MRI scanning before and after intravenous administration of Endorem Receives: Drug: Administration of Endorem |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in signal intensity in the region of interest on MRI scanning
Measured: 0 hours, 24 hours, 48 hours, 5-7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2009 (estimated)
- Study startSep 2009
- Primary completion6 Jan 2012
- Study completion6 Jan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteerStudies of the same condition, open and under way.
- More trials run by University of EdinburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Edinburgh
- Sponsor type
- University, hospital or other
- Collaborators
- Royal College of Surgeons of Edinburgh, Translational Medicine Research Collaboration
- Responsible party
- Sponsor
- Investigators
- David E Newby, Principal investigator, University of Edinburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00972946
- Sponsor's protocol ID
- 2007/R/CAR/15.2
- Status last verified
- Jun 2021
- First submitted
- 7 Sep 2009
- Last updated
- 15 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 22787016
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Magnetic Resonance Imaging and Superparamagnetic Particles of Iron Oxide in Cardiovascular Disease - a Pilot Study in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT00972946
- Acronym / sponsor ID
- 2007/R/CAR/15.2
- Conditions
- Healthy Volunteer
- Keywords
- MRI, SPIO
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of EdinburghUniversity, hospital or other
- Collaborators
- Royal College of Surgeons of Edinburgh, Translational Medicine Research Collaboration
- Study start
- Sep 2009 (actual)
- Primary completion
- 6 Jan 2012 (actual)
- Study completion
- 6 Jan 2012 (actual)
- First posted
- 9 Sep 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Assess the feasibility of imaging Endorem-labelled cells in vivo
- Compare the distribution of Endorem-labelled cells with that of intravenous injection of Endorem
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Administration of labelled cells | Experimental | Biological: Administration of autologous Endorem-labelled mononuclear cells intravenouslyMRI scanning before and after administration of iron-labelled cells |
| Administration of Endorem | Experimental | Drug: Administration of EndoremMRI scanning before and after intravenous administration of Endorem |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Healthy volunteers
- Age >18 years
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Administration of autologous Endorem-labelled mononuclear cells intravenouslysingle dose | Biological | Administration of labelled cells |
| Administration of Endoremsingle dose, intravenous | Drug | Administration of Endorem |
Primary outcome
Change in signal intensity in the region of interest on MRI scanning
Time frame: 0 hours, 24 hours, 48 hours, 5-7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2021.
- Results publication: PubMed 22787016Richards 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David E Newby principal investigator
University of Edinburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Administration of autologous Endorem-labelled mononuclear cells intravenously and Administration of Endorem in people with Healthy Volunteer, run by University of Edinburgh at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in signal intensity in the region of interest on MRI scanning (time frame: 0 hours, 24 hours, 48 hours, 5-7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00972946, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2021.