in vivo tracking of uspio labeled msc in the heart

Conditions: Ischemic Heart Disease

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.

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.

Eligibility criteria:
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