Endothelial Progenitor CellsNCT02975518
Tracking Endothelial Cells in Arterial Injury
A study testing Administration of radio labelled endothelial outgrowth cells in people with Endothelial Progenitor Cells and Coronary Artery Disease, run by University of Edinburgh at 1 site in United Kingdom.
Trial summary
We plan to track the migratory behaviour of culture-expanded enothelial outgrowth cells in the context of vascular injury sustained during elective coronary angiography. We will use Flouro-deoxyglucose-labelling and PET-CT to track the endothelial cells. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Endothelial Progenitor Cells, Coronary Artery Disease, Vascular Injury
- What is being tested?
- Administration of radio labelled endothelial outgrowth cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Dec 2015to 12 Mar 2018
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Undergoing coronary angiography for known or suspected ischaemic heart disease
Who cannot join
- Previous coronary artery bypass surgery.
- Planned angiography via the femoral artery as a sole arterial access route
- Anaemia <10g/L
- Severe valvular heart disease
- Acute myocardial infarction within previous three months
- Cardiac failure (Killip class ≥II).
Show all 12Show fewer
- Insulin dependent diabetes mellitus
- Hepatic failure (Childs-Pugh grades B or C).
- Renal failure (estimated glomerular filtration rate <25 mL/min).
- Intercurrent illness including patients with a systemic inflammatory disorder or underlying malignancy.
- Women of child-bearing age not ensuring reliable methods of contraception.
- Inability to provide informed consent.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University of Edinburgh
Edinburgh, Midlothian, EH74DL
About this study
We plan to track the migratory behaviour of culture-expanded enothelial outgrowth cells in the context of vascular injury sustained during elective coronary angiography.
We will use Flouro-deoxyglucose-labelling and PET-CT to track the endothelial cells.
Read the detailed description
The radial artery is commonly injured following trans-radial cardiac catheterisation and this injury can be demonstrated as a reduction in endothelial function as measured by flow-mediated dilatation which recovers with time (13-15). Thus the radial artery is useful as a model of mechanical arterial injury as radial artery trauma is common and endothelial function can be followed longitudinally with a non-invasive test.
Endothelial progenitor cells localise to sites of arterial injury in animal models both in vitro and in vivo and accelerate re-endothelialisation as well as attenuating neointimal hyperplasia (16-18), This has however not been demonstrated in man.
Our research group, in collaboration with the Scottish Blood Transfusion Service (SNBTS) have developed a good manufacturing practice (GMP)-compliant process for manufacturing an endothelial progenitor cell (EPC) product (SNBTS will manufacture the final product administered to patients). We have also demonstrated in vitro that we can label these cells with the radioisotope 18 F-fluorodeoxyglucose (18F-FDG) and that activity can be detected in as few as 200 cells using a hybrid positron emission and computed tomography (PET-CT) scanner (Biograph mCT Siemens Medical Systems, Erlangen, Germany). We will therefore be able to track the fate of these cells in vivo. The major potential advantage of imaging in this way is that only 18F-FDG associated with EPCs will be delivered to the patient, removing the issue of background attenuation due to "free" circulating 18F-FDG. A similar technique has previously been employed in vivo to track homing of unselected autologous bone marrow cells to infarcted myocardium(19). Following intracoronary delivery using this technique, the authors were able to detect 1.3% - 2.6% of 18F-FDG-labelled cells in the infarcted myocardium. Demonstrating that EPCs are able to home to and integrate at sites of vascular injury in man is a critical step in understanding the role of EPCs in vascular repair
- Conditions
- Endothelial Progenitor Cells, Coronary Artery Disease, Vascular Injury, Coronary Angiography
- Being tested
- Administration of radio labelled endothelial outgrowth cells
- Medical subject headings
- Coronary Artery Disease, Vascular System Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Administration of radio labelled endothelial outgrowth cellsBiological
Radio labelled endothelial outgrowth cells will be administered to patients undergoing elective coronary angiography and stenting. They will be administered intra-venously and intra-arterially (right radial artery) in separate arms. Migratory behaviour of these cells will be defined using PET CT. Intra-venous and intra-arterial injection of free radio tracer will serve as a control comparator arms.
| Study group | Role | What they receive |
|---|---|---|
| Intra-venous infusion of Flourodeoxyglucose | Active comparator | As a control for radio labelled cells, Flourodeoxyglucose will be administered intra-venously at an activity equal to that injected with the labelled endothelial cells. Receives: Biological: Administration of radio labelled endothelial outgrowth cells |
| Intra-Arterial infusion of Flourodeoxyglucose | Active comparator | As a control for radio labelled cells, Flourodeoxyglucose will be administered intra-arterially at an activity equal to that injected with the labelled endothelial cells. Receives: Biological: Administration of radio labelled endothelial outgrowth cells |
| Intra-venous injection of radio-labelled endothelial cells | Experimental | Endothelial cells labelled with flourodeoxyglucose will be injected intra-venously with their distribution tracked using PET CT. Receives: Biological: Administration of radio labelled endothelial outgrowth cells |
| Intra-Arterial injection of radio-labelled endothelial cells | Experimental | Endothelial cells labelled with flourodeoxyglucose will be injected intra-arterially with their distribution tracked using PET CT. Receives: Biological: Administration of radio labelled endothelial outgrowth cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Standard uptake value
Standard-uptake values of injured sections of artery will be compared to remote uninjured artery
Measured: 0-4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2016 (estimated)
- Study startDec 2015
- Primary completion12 Mar 2018
- Study completion12 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endothelial Progenitor CellsStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Edinburgh
- Sponsor type
- University, hospital or other
- Collaborators
- British Heart Foundation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02975518
- Sponsor's protocol ID
- Protocol v 3
- Status last verified
- Jul 2021
- First submitted
- 23 Nov 2016
- Last updated
- 16 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tracking Endothelial Cells in Arterial Injury
- ClinicalTrials.gov ID
- NCT02975518
- Acronym / sponsor ID
- Protocol v 3
- Conditions
- Endothelial Progenitor Cells, Coronary Artery Disease, Vascular Injury, Coronary Angiography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- University of EdinburghUniversity, hospital or other
- Collaborators
- British Heart Foundation
- Study start
- Dec 2015 (actual)
- Primary completion
- 12 Mar 2018 (actual)
- Study completion
- 12 Mar 2018 (actual)
- First posted
- 29 Nov 2016 (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.
We plan to track the migratory behaviour of culture-expanded enothelial outgrowth cells in the context of vascular injury sustained during elective coronary angiography.
We will use Flouro-deoxyglucose-labelling and PET-CT to track the endothelial cells.
Detailed description
The radial artery is commonly injured following trans-radial cardiac catheterisation and this injury can be demonstrated as a reduction in endothelial function as measured by flow-mediated dilatation which recovers with time (13-15). Thus the radial artery is useful as a model of mechanical arterial injury as radial artery trauma is common and endothelial function can be followed longitudinally with a non-invasive test.
Endothelial progenitor cells localise to sites of arterial injury in animal models both in vitro and in vivo and accelerate re-endothelialisation as well as attenuating neointimal hyperplasia (16-18), This has however not been demonstrated in man.
Our research group, in collaboration with the Scottish Blood Transfusion Service (SNBTS) have developed a good manufacturing practice (GMP)-compliant process for manufacturing an endothelial progenitor cell (EPC) product (SNBTS will manufacture the final product administered to patients). We have also demonstrated in vitro that we can label these cells with the radioisotope 18 F-fluorodeoxyglucose (18F-FDG) and that activity can be detected in as few as 200 cells using a hybrid positron emission and computed tomography (PET-CT) scanner (Biograph mCT Siemens Medical Systems, Erlangen, Germany). We will therefore be able to track the fate of these cells in vivo. The major potential advantage of imaging in this way is that only 18F-FDG associated with EPCs will be delivered to the patient, removing the issue of background attenuation due to "free" circulating 18F-FDG. A similar technique has previously been employed in vivo to track homing of unselected autologous bone marrow cells to infarcted myocardium(19). Following intracoronary delivery using this technique, the authors were able to detect 1.3% - 2.6% of 18F-FDG-labelled cells in the infarcted myocardium. Demonstrating that EPCs are able to home to and integrate at sites of vascular injury in man is a critical step in understanding the role of EPCs in vascular repair
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Intra-venous infusion of Flourodeoxyglucose | Active comparator | Biological: Administration of radio labelled endothelial outgrowth cellsAs a control for radio labelled cells, Flourodeoxyglucose will be administered intra-venously at an activity equal to that injected with the labelled endothelial cells. |
| Intra-Arterial infusion of Flourodeoxyglucose | Active comparator | Biological: Administration of radio labelled endothelial outgrowth cellsAs a control for radio labelled cells, Flourodeoxyglucose will be administered intra-arterially at an activity equal to that injected with the labelled endothelial cells. |
| Intra-venous injection of radio-labelled endothelial cells | Experimental | Biological: Administration of radio labelled endothelial outgrowth cellsEndothelial cells labelled with flourodeoxyglucose will be injected intra-venously with their distribution tracked using PET CT. |
| Intra-Arterial injection of radio-labelled endothelial cells | Experimental | Biological: Administration of radio labelled endothelial outgrowth cellsEndothelial cells labelled with flourodeoxyglucose will be injected intra-arterially with their distribution tracked using PET CT. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Undergoing coronary angiography for known or suspected ischaemic heart disease
Key exclusion criteria (12 listed)
- Previous coronary artery bypass surgery.
- Planned angiography via the femoral artery as a sole arterial access route
- Anaemia <10g/L
- Severe valvular heart disease
- Acute myocardial infarction within previous three months
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 radio labelled endothelial outgrowth cellsRadio labelled endothelial outgrowth cells will be administered to patients undergoing elective coronary angiography and stenting. They will be administered intra-venously and intra-arterially (right radial artery) in separate arms. Migratory behaviour of these cells will be defined using PET CT. Intra-venous and intra-arterial injection of free radio tracer will serve as a control comparator arms. | Biological | Intra-Arterial infusion of Flourodeoxyglucose, Intra-Arterial injection of radio-labelled endothelial cells, Intra-venous infusion of Flourodeoxyglucose, Intra-venous injection of radio-labelled endothelial cells |
Primary outcome
Standard uptake value
Time frame: 0-4 hours
Standard-uptake values of injured sections of artery will be compared to remote uninjured artery
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 16 Jul 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 radio labelled endothelial outgrowth cells in people with Endothelial Progenitor Cells and Coronary Artery Disease, 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 1 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 16 Jul 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?
Standard uptake value (time frame: 0-4 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Jul 2021.