HealthyNCT01169935
Tracking Inflammatory Cells Using Superparamagnetic Particles of Iron Oxide (SPIO) and Magnetic Resonance Imaging (MRI)
A study testing Administration of intra-dermal Endorem, Mantoux test and Autologous Endorem-labelled mononuclear cells in people with Healthy, run by University of Edinburgh at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Administration of intra-dermal Endorem, Mantoux test and Autologous Endorem-labelled mononuclear cells
- 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
- Jul 2010to Apr 2011
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy male or female volunteers age 18 to 65 years
- Previous vaccine for tuberculosis more than 5 years ago
Who cannot join
- 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
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University of Edinburgh / Royal Infirmary of Edinburgh
Edinburgh, Scotland, EH16SU4
About this study
Official title: In Vivo Tracking of Magnetically-labelled Human Mononuclear Cells Using MRI Scanning
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.
- Conditions
- Healthy
- Being tested
- Administration of intra-dermal Endorem, Mantoux test, Autologous Endorem-labelled mononuclear cells, Administration of Endorem
- Keywords
- MRI, SPIO, Healthy Volunteer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Administration of intra-dermal EndoremDrug
single dose, intradermal
Mantoux testBiological
single dose, intradermal
Autologous Endorem-labelled mononuclear cellsBiological
single dose, intravenous
Administration of EndoremDrug
single dose, intravenous
| Study group | Role | What they receive |
|---|---|---|
| Administration of Intra-dermal SPIO | Experimental | MRI scanning before and after intra-dermal injection of SPIO. Receives: 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. Receives: Biological: Mantoux test; Biological: 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. Receives: Biological: Mantoux test; Biological: Autologous Endorem-labelled mononuclear cells |
| Mantoux, Administration of Endorem | Experimental | Mantoux test then MRI scanning before and after administration of Endorem. Receives: Biological: Mantoux test; Drug: Administration of Endorem |
| Mantoux only | Experimental | Mantoux test then serial MRI scanning. Receives: Biological: Mantoux test |
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, 3 - 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2010 (estimated)
- Study startJul 2010
- Primary completionApr 2011
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 HealthyStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Edinburgh
- Sponsor type
- University, hospital or other
- Collaborators
- Translational Medicine Research Collaboration, British Heart Foundation
- Responsible party
- Sponsor
- Investigators
- Jenny M Richards, MBChB MRCS, Principal investigator, University of Edinburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01169935
- Sponsor's protocol ID
- 10/S1102/31
- Status last verified
- Feb 2013
- First submitted
- 23 Jul 2010
- Last updated
- 5 Feb 2013
- 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 5 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In Vivo Tracking of Magnetically-labelled Human Mononuclear Cells Using MRI Scanning
- ClinicalTrials.gov ID
- NCT01169935
- Acronym / sponsor ID
- 10/S1102/31
- Conditions
- Healthy
- Keywords
- MRI, SPIO, Healthy Volunteer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of EdinburghUniversity, hospital or other
- Collaborators
- Translational Medicine Research Collaboration, British Heart Foundation
- Study start
- Jul 2010
- Primary completion
- Apr 2011 (actual)
- First posted
- 26 Jul 2010 (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.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Administration of Intra-dermal SPIO | Experimental | Drug: Administration of intra-dermal EndoremMRI scanning before and after intra-dermal injection of SPIO. |
| Mantoux, Venesection, Labelled cells | Experimental | Biological: Mantoux test, Biological: Autologous Endorem-labelled mononuclear cellsMantoux test then MRI scanning before and after administration of iron-labelled cells obtained by venesection. |
| Mantoux, Apheresis, Labelled cells | Experimental | Biological: Mantoux test, Biological: Autologous Endorem-labelled mononuclear cellsMantoux test then MRI scanning before and after administration of iron-labelled cells obtained by apheresis. |
| Mantoux, Administration of Endorem | Experimental | Biological: Mantoux test, Drug: Administration of EndoremMantoux test then MRI scanning before and after administration of Endorem. |
| Mantoux only | Experimental | Biological: Mantoux testMantoux test then serial MRI scanning. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Healthy male or female volunteers age 18 to 65 years
- Previous vaccine for tuberculosis more than 5 years ago
Key exclusion criteria (12 listed)
- 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
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 intra-dermal Endoremsingle dose, intradermal | Drug | Administration of Intra-dermal SPIO |
| Mantoux testsingle dose, intradermal | Biological | Mantoux only, Mantoux, Administration of Endorem, Mantoux, Apheresis, Labelled cells, Mantoux, Venesection, Labelled cells |
| Autologous Endorem-labelled mononuclear cellssingle dose, intravenous | Biological | Mantoux, Apheresis, Labelled cells, Mantoux, Venesection, Labelled cells |
| Administration of Endoremsingle dose, intravenous | Drug | Mantoux, 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, 3 - 5 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 5 Feb 2013.
- Derived from this study: 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.
Jenny M Richards, MBChB MRCS 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 intra-dermal Endorem, Mantoux test and Autologous Endorem-labelled mononuclear cells in people with Healthy, 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 12 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 5 Feb 2013. 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, 3 - 5 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 NCT01169935, 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 5 Feb 2013.