Ischemic Heart Disease
Conditions
Brief 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.
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.
Interventions
COMBINATION_PRODUCTUSPIO labeled MSC injection
USPIO labeled MSC injection
Sponsors
Rigshospitalet, Denmark
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to 80 Years
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
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| MSC identification using MRI in-vivo on day 0 | 24 hours | Being able to identify the iron-oxide labeled mesenchymal stromal cells on day 0 after injection into the myocardium by MRI. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| MSC identification using MRI in-vivo on day 7 | 7 days | Being able to identify the iron-oxide labeled mesenchymal stromal cells on day 7 |
| MSC identification using MRI in-vivo after 2 weeks | 2 weeks | Being able to identify the iron-oxide labeled mesenchymal stromal cells after 2 weeks |
| MSC identification using MRI in-vivo after 4 weeks | 4 weeks | Being able to identify the iron-oxide labeled mesenchymal stromal cells after 4 weeks |
| MSC identification using MRI in-vivo after 8 weeks | 8 weeks | Being able to identify the iron-oxide labeled mesenchymal stromal cells after 8 weeks |
| MSC identification using MRI in-vivo after 12 weeks | 12 weeks | Being able to identify the iron-oxide labeled mesenchymal stromal cells after 12 weeks |
| MSC identification using MRI in-vivo after 26 weeks | 26 weeks | Being able to identify the iron-oxide labeled mesenchymal stromal cells after 26 weeks |
| MSC identification using MRI in-vivo on day 1 | 1 day | Being able to identify the iron-oxide labeled mesenchymal stromal cells on day 1 |
| CCS class | 12 weeks | Canadian Cardiovascular Society (CCS) class after 12 weeks |
| Seattle Angina Questionnaire | 12 weeks | Seattle Angina Questionnaire after 12 weeks |
| Weekly number of angina attacks | 12 weeks | Weekly number of angina attacks after 12 weeks |
| Weekly nitroglycerin consumption | 12 weeks | Weekly nitroglycerin consumption after 12 weeks |
| Adverse events | 6 months | Adverse events registration |
| Cardiac pump function changes | 12 weeks | Left ventricular ejection fraction, systolic and diastolic volumes after 12 weeks |
Outcome results
None listed