Ischemic Heart Disease Clinical Trial
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.
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.
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