CompletedNCT03651791USPIO-MSCUpdated Aug 29, 2018

In Vivo Tracking of USPIO Labeled MSC in the Heart

A Phase 1 interventional study of USPIO labeled MSC injection in Ischemic Heart Disease, sponsored by Rigshospitalet, Denmark. Completed. Open to participants aged 30 Years to 80 Years. Per ClinicalTrials.gov, last updated 2018-08-29.

Sponsored by Rigshospitalet, Denmark · Phase 1, Interventional, and Treatment

From the registry’s dates

Registered 5 years 3 months after the study started (first participant enrolled May 2013, registered Aug 2018).

Phase: Phase 1
Study type: Interventional
Enrollment: 5
Allocation: Not applicable
Ages: 30 Years to 80 Years
Sex: All

Study 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 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 studied

Ischemic Heart Disease

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In context

Heart Diseases

3,639 studies on the registry are indexed under Heart Diseases; 461 are open to participants now.

This study's enrollment of 5 is below the median of 100 across 1,778 interventional studies indexed under Heart Diseases.

Browse Heart Diseases studies →

Lead sponsor

Rigshospitalet, Denmark is the lead sponsor of 1,017 studies on the registry; 183 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 30 Years to 80 Years
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

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.

Exclusion criteria

Exclusion Criteria:

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.
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

Study design

Phase: Phase 1
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 5 participants (actual)

Study arms

Experimental
USPIO labeled MSC injection
USPIO labeled MSC injection
Combination Product: USPIO labeled MSC injection

Interventions

Combination productUSPIO labeled MSC injection
USPIO labeled MSC injection

What researchers measure

Primary outcomes

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.
Time frame: 24 hours

Secondary outcomes

MSC identification using MRI in-vivo on day 1
Being able to identify the iron-oxide labeled mesenchymal stromal cells on day 1
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 26 weeks
Cardiac pump function changes
Left ventricular ejection fraction, systolic and diastolic volumes after 12 weeks
Time frame: 12 weeks
Cardiac pump function changes
Left ventricular ejection fraction, systolic and diastolic volumes after 26 weeks
Time frame: 26 weeks
CCS class
Canadian Cardiovascular Society (CCS) class after 12 weeks
Time frame: 12 weeks
CCS class
Canadian Cardiovascular Society (CCS) class after 26 weeks
Time frame: 26 weeks
Seattle Angina Questionnaire
Seattle Angina Questionnaire after 12 weeks
Time frame: 12 weeks
Seattle Angina Questionnaire
Seattle Angina Questionnaire after 26 weeks
Time frame: 26 weeks
Weekly number of angina attacks
Weekly number of angina attacks after 12 weeks
Time frame: 12 weeks
Weekly number of angina attacks
Weekly number of angina attacks after 26 weeks
Time frame: 26 weeks
Weekly nitroglycerin consumption
Weekly nitroglycerin consumption after 12 weeks
Time frame: 12 weeks
Weekly nitroglycerin consumption
Weekly nitroglycerin consumption after 26 weeks
Time frame: 26 weeks
Adverse events
Adverse events registration
Time frame: 6 months

Study locations

No study locations are listed for this record.

References and documents

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 23577035 ↗
Hansen 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 24734781 ↗
Mathiasen 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 ↗

Individual participant data

Plan to share: Undecided

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Aug 29, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT03651791
Lead sponsor: Rigshospitalet, Denmark
Responsible party: Anders Bruun Mathiasen (Principal Investigator, Rigshospitalet, Denmark) — Principal investigator
First posted: Aug 29, 2018
Start date: May 2013
Primary completion: Jun 2014
Completion: Oct 2017
Last update: Aug 29, 2018

Study contacts

Jens Kastrup, MD DMSc

study director · The Heart Centre, Rigshospitalet, University of Copenhagen

Oversight

Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.

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