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.
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
5
USPIO labeled MSC injection
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
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
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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