Ischemic Heart DiseasePhase 1USPIO-MSCNCT03651791
In Vivo Tracking of USPIO Labeled MSC in the Heart
A Phase 1 study testing USPIO labeled MSC injection in people with Ischemic Heart Disease, run by Copenhagen University Hospital, Rigshospitalet.
Trial summary
To evaluate the ability to trace iron oxide-labeled mesenchymal stromal cells with magnetic resonance imaging (MRI) after NOGA-guided injection therapy into the myocardium in patients with ischemic heart disease. Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Ischemic Heart Disease
- What is being tested?
- USPIO labeled MSC injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- No sites listed yet
- Study dates
- May 2013to Oct 2017
- Phase
- Phase 1
- 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 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 30 and 80 years.
- Signed informed consent.
- Chronic stable ischemic heart disease
- New York Heart Association (NYHA) class II-IV or Canadian Cardiovascular Society (CCS) class II-IV
- Maximal tolerable angina and/or heart failure medication.
- Angiography within 12 months of inclusion. Angiography must have at least one larger coronary vessel with a significant stenosis with no option for revascularization (Angiographies evaluated by an independent thoracic surgeon and an interventional cardiologist).
- Patients who have had revascularization done within 6 months of inclusion must have a new angiography at least 4 months after the intervention to rule out early restenosis.
Who cannot join
- Pregnant or fertile women.
- Clinical significant anemia, leukopenia, leukocytosis or thrombocythemia.
- Diminished functional capacity for other reasons such as: chronic obstructive pulmonary disease (COLD) with Forced Expiratory Volume in 1 second (FEV1)<1 L/min, moderate to severe claudication or morbid obesity.
- Patients with reduced immune response or treated with immunosuppressive medication.
- Moderate to severe valvular disease or valvular disease with option for valvular surgery.
- Acute coronary syndrome with elevation of coronary markers, stroke or Transitory Cerebral Ischemia (TCI) within 6 weeks of inclusion.
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- History with malignant disease within 5 years of inclusion or suspected malignity.
- Other experimental treatment within 4 weeks of baseline evaluation.
- Other revascularization treatment within 4 months of treatment.
- Contraindications for Magnetic Resonance Imaging (MRI) such as: Claustrophobia, pacemaker, Implantable Cardioverter Defibrillator (ICD) unit, metal fragments or metal implants in the cranium
About this study
Official title: In Vivo MRI Tracking of Mesenchymal Stromal Cells Labeled With Ultra-Small Paramagnetic Iron Oxide Particles After Intramyocardial Transplantation in Patients With Chronic Ischemic Heart Disease
To evaluate the ability to trace iron oxide-labeled mesenchymal stromal cells with magnetic resonance imaging (MRI) after NOGA-guided injection therapy into the myocardium in patients with ischemic heart disease.
Read the detailed description
Aims:
To evaluate the ability to trace iron oxide-labeled mesenchymal stromal cells with magnetic resonance imaging (MRI) after NOGA-guided injection therapy into the myocardium.
To evaluate the safety and efficacy of treatment with iron oxide-labeled mesenchymal stromal cells to form new heart muscle cells and blood vessels in the myocardium submitted by NOGA-guided injection therapy in the myocardium in order to improve myocardial blood flow and reduce patients' symptoms.
Patient Population:
Patients with coronary artery disease not treatable with additional bypass surgery or percutaneous coronary intervention who have angina pectoris (Canadian Cardiovascular Society (CCS) class II-III) or angina equivalent shortness of breath (New York Heart Association (NYHA) class II -III).
Study Design A prospective, non-randomized, pilot study including 5-10 patients. Patients will by means of the percutaneous NOGA injection catheter system receive 12-15 intramyocardial injections. The number depending on the amount of cultured cells and distributed uniformly in the peripheral zone of a presumed ischemic area in the left ventricle demonstrated by angiography, magnetic resonance imaging and NOGA mapping.
- Conditions
- Ischemic Heart Disease
- Being tested
- USPIO labeled MSC injection
- Medical subject headings
- Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
USPIO labeled MSC injectionCombination product
USPIO labeled MSC injection
| Study group | Role | What they receive |
|---|---|---|
| USPIO labeled MSC injection | Experimental | USPIO labeled MSC injection Receives: Combination Product: USPIO labeled MSC injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
MSC identification using MRI in-vivo on day 0
Being able to identify the iron-oxide labeled mesenchymal stromal cells on day 0 after injection into the myocardium by MRI.
Measured: 24 hours
Secondary outcomes (18)
MSC identification using MRI in-vivo on day 1
Being able to identify the iron-oxide labeled mesenchymal stromal cells on day 1
Measured: 1 day
MSC identification using MRI in-vivo on day 7
Being able to identify the iron-oxide labeled mesenchymal stromal cells on day 7
Measured: 7 days
MSC identification using MRI in-vivo after 2 weeks
Being able to identify the iron-oxide labeled mesenchymal stromal cells after 2 weeks
Measured: 2 weeks
MSC identification using MRI in-vivo after 4 weeks
Being able to identify the iron-oxide labeled mesenchymal stromal cells after 4 weeks
Measured: 4 weeks
MSC identification using MRI in-vivo after 8 weeks
Being able to identify the iron-oxide labeled mesenchymal stromal cells after 8 weeks
Measured: 8 weeks
MSC identification using MRI in-vivo after 12 weeks
Being able to identify the iron-oxide labeled mesenchymal stromal cells after 12 weeks
Measured: 12 weeks
MSC identification using MRI in-vivo after 26 weeks
Being able to identify the iron-oxide labeled mesenchymal stromal cells after 26 weeks
Measured: 26 weeks
Cardiac pump function changes
Left ventricular ejection fraction, systolic and diastolic volumes after 12 weeks
Measured: 12 weeks
Cardiac pump function changes
Left ventricular ejection fraction, systolic and diastolic volumes after 26 weeks
Measured: 26 weeks
CCS class
Canadian Cardiovascular Society (CCS) class after 12 weeks
Measured: 12 weeks
CCS class
Canadian Cardiovascular Society (CCS) class after 26 weeks
Measured: 26 weeks
Seattle Angina Questionnaire
Seattle Angina Questionnaire after 12 weeks
Measured: 12 weeks
Seattle Angina Questionnaire
Seattle Angina Questionnaire after 26 weeks
Measured: 26 weeks
Weekly number of angina attacks
Weekly number of angina attacks after 12 weeks
Measured: 12 weeks
Weekly number of angina attacks
Weekly number of angina attacks after 26 weeks
Measured: 26 weeks
Weekly nitroglycerin consumption
Weekly nitroglycerin consumption after 12 weeks
Measured: 12 weeks
Weekly nitroglycerin consumption
Weekly nitroglycerin consumption after 26 weeks
Measured: 26 weeks
Adverse events
Adverse events registration
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2018
- Study startMay 2013
- Primary completionJun 2014
- Study completionOct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Ischemic Heart DiseaseStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anders Bruun Mathiasen, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Jens Kastrup, MD DMSc, Study director, The Heart Centre, Rigshospitalet, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03651791
- Sponsor's protocol ID
- USPIO-MSC1
- Acronym
- USPIO-MSC
- Status last verified
- Aug 2018
- First submitted
- 23 Aug 2018
- Last updated
- 29 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Mathiasen AB, Hansen L, Friis T, Thomsen C, Bhakoo K, Kastrup J. Optimal labeling dose, labeling time, and magnetic resonance imaging detection limits of ultrasmall superparamagnetic iron-oxide nanoparticle labeled mesenchymal stromal cells. Stem Cells Int. 2013;2013:353105. doi: 10.1155/2013/353105. Epub 2013 Mar 19.
PubMed 23577035Hansen L, Hansen AB, Mathiasen AB, Ng M, Bhakoo K, Ekblond A, Kastrup J, Friis T. Ultrastructural characterization of mesenchymal stromal cells labeled with ultrasmall superparamagnetic iron-oxide nanoparticles for clinical tracking studies. Scand J Clin Lab Invest. 2014 Aug;74(5):437-46. doi: 10.3109/00365513.2014.900698. Epub 2014 Apr 15.
PubMed 24734781Mathiasen AB, Qayyum AA, Jorgensen E, Helqvist S, Ekblond A, Ng M, Bhakoo K, Kastrup J. In Vivo MRI Tracking of Mesenchymal Stromal Cells Labeled with Ultrasmall Paramagnetic Iron Oxide Particles after Intramyocardial Transplantation in Patients with Chronic Ischemic Heart Disease. Stem Cells Int. 2019 Nov 14;2019:2754927. doi: 10.1155/2019/2754927. eCollection 2019.
PubMed 31814830
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In Vivo MRI Tracking of Mesenchymal Stromal Cells Labeled With Ultra-Small Paramagnetic Iron Oxide Particles After Intramyocardial Transplantation in Patients With Chronic Ischemic Heart Disease
- ClinicalTrials.gov ID
- NCT03651791
- Acronym / sponsor ID
- USPIO-MSC / USPIO-MSC1
- Conditions
- Ischemic Heart Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- May 2013 (actual)
- Primary completion
- Jun 2014 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 29 Aug 2018 (actual)
- 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.
To evaluate the ability to trace iron oxide-labeled mesenchymal stromal cells with magnetic resonance imaging (MRI) after NOGA-guided injection therapy into the myocardium in patients with ischemic heart disease.
Detailed description
Aims:
To evaluate the ability to trace iron oxide-labeled mesenchymal stromal cells with magnetic resonance imaging (MRI) after NOGA-guided injection therapy into the myocardium.
To evaluate the safety and efficacy of treatment with iron oxide-labeled mesenchymal stromal cells to form new heart muscle cells and blood vessels in the myocardium submitted by NOGA-guided injection therapy in the myocardium in order to improve myocardial blood flow and reduce patients' symptoms.
Patient Population:
Patients with coronary artery disease not treatable with additional bypass surgery or percutaneous coronary intervention who have angina pectoris (Canadian Cardiovascular Society (CCS) class II-III) or angina equivalent shortness of breath (New York Heart Association (NYHA) class II -III).
Study Design A prospective, non-randomized, pilot study including 5-10 patients. Patients will by means of the percutaneous NOGA injection catheter system receive 12-15 intramyocardial injections. The number depending on the amount of cultured cells and distributed uniformly in the peripheral zone of a presumed ischemic area in the left ventricle demonstrated by angiography, magnetic resonance imaging and NOGA mapping.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| USPIO labeled MSC injection | Experimental | Combination Product: USPIO labeled MSC injectionUSPIO labeled MSC injection |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age between 30 and 80 years.
- Signed informed consent.
- Chronic stable ischemic heart disease
- New York Heart Association (NYHA) class II-IV or Canadian Cardiovascular Society (CCS) class II-IV
- Maximal tolerable angina and/or heart failure medication.
Key exclusion criteria (10 listed)
- Pregnant or fertile women.
- Clinical significant anemia, leukopenia, leukocytosis or thrombocythemia.
- Diminished functional capacity for other reasons such as: chronic obstructive pulmonary disease (COLD) with Forced Expiratory Volume in 1 second (FEV1)<1 L/min, moderate to severe claudication or morbid obesity.
- Patients with reduced immune response or treated with immunosuppressive medication.
- Moderate to severe valvular disease or valvular disease with option for valvular surgery.
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 |
|---|---|---|
| USPIO labeled MSC injectionUSPIO labeled MSC injection | Combination product | USPIO labeled MSC injection |
Primary outcome
MSC identification using MRI in-vivo on day 0
Time frame: 24 hours
Being able to identify the iron-oxide labeled mesenchymal stromal cells on day 0 after injection into the myocardium by MRI.
18 secondary outcomes
MSC identification using MRI in-vivo on day 1
Time frame: 1 day
MSC identification using MRI in-vivo on day 7
Time frame: 7 days
MSC identification using MRI in-vivo after 2 weeks
Time frame: 2 weeks
MSC identification using MRI in-vivo after 4 weeks
Time frame: 4 weeks
MSC identification using MRI in-vivo after 8 weeks
Time frame: 8 weeks
MSC identification using MRI in-vivo after 12 weeks
Time frame: 12 weeks
MSC identification using MRI in-vivo after 26 weeks
Time frame: 26 weeks
Cardiac pump function changes
Time frame: 12 weeks
Cardiac pump function changes
Time frame: 26 weeks
CCS class
Time frame: 12 weeks
CCS class
Time frame: 26 weeks
Seattle Angina Questionnaire
Time frame: 12 weeks
Seattle Angina Questionnaire
Time frame: 26 weeks
Weekly number of angina attacks
Time frame: 12 weeks
Weekly number of angina attacks
Time frame: 26 weeks
Weekly nitroglycerin consumption
Time frame: 12 weeks
Weekly nitroglycerin consumption
Time frame: 26 weeks
Adverse events
Time frame: 6 months
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 29 Aug 2018.
- Background: PubMed 23577035Mathiasen AB, Hansen L, Friis T, Thomsen C, Bhakoo K, Kastrup J. Optimal labeling dose, labeling time, and magnetic resonance imaging detection limits of ultrasmall superparamagnetic iron-oxide nanoparticle labeled mesenchymal stromal cells. Stem Cells Int. 2013;2013:353105. doi: 10.1155/2013/353105. Epub 2013 Mar 19.
- Background: PubMed 24734781Hansen L, Hansen AB, Mathiasen AB, Ng M, Bhakoo K, Ekblond A, Kastrup J, Friis T. Ultrastructural characterization of mesenchymal stromal cells labeled with ultrasmall superparamagnetic iron-oxide nanoparticles for clinical tracking studies. Scand J Clin Lab Invest. 2014 Aug;74(5):437-46. doi: 10.3109/00365513.2014.900698. Epub 2014 Apr 15.
- Derived from this study: PubMed 31814830Mathiasen AB, Qayyum AA, Jorgensen E, Helqvist S, Ekblond A, Ng M, Bhakoo K, Kastrup J. In Vivo MRI Tracking of Mesenchymal Stromal Cells Labeled with Ultrasmall Paramagnetic Iron Oxide Particles after Intramyocardial Transplantation in Patients with Chronic Ischemic Heart Disease. Stem Cells Int. 2019 Nov 14;2019:2754927. doi: 10.1155/2019/2754927. eCollection 2019.
- Individual participant dataSharing planned: Undecided
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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.
Jens Kastrup, MD DMSc study director
The Heart Centre, Rigshospitalet, University of Copenhagen
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing USPIO labeled MSC injection in people with Ischemic Heart Disease, run by Copenhagen University Hospital, Rigshospitalet.
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 7 inclusion and 10 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 29 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
MSC identification using MRI in-vivo on day 0 (time frame: 24 hours). 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 NCT03651791, which also lists 3 linked publications.
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 29 Aug 2018.