Coronary Artery Disease Clinical Trial
Official title:
Phase I / II Clinical Trial Regarding Vascular Regeneration Therapy by Transplantation of Autologous Peripheral Blood Endothelial Progenitor Cells (CD34+ Cells) in No-Option Patients With Chronic Myocardial Ischemia
The purpose of this study is to determine if stem cell therapy with your own cells (autologous cells) delivered with a catheter to regions of the heart with poor blood flow will be safe and if it will relieve your chest pain, increase the blood flow, and/or improve the cardiac contractility (function) by regenerating blood vessels in your heart.
Chronic myocardial ischemia (MI) is a progressive disease, which arises as a result of atherosclerosis in coronary arteries. Prognosis of chronic MI is poor, and no effective treatments have been established in patients who are not eligible for the traditional revascularization therapies such as angioplasty and bypass procedures due to the inappropriate anatomy of the coronary arteries or frequent reocclusion following revascularization. Therefore, it is necessary to establish novel revascularization treatment to improve prognosis of the no-option patients. We will study the safety and clinical efficiency of vascular regeneration by means of transplantation of autologous peripheral blood endothelial progenitor cells (CD34 positive cells) in patients with severe chronic coronary artery disease (CAD) who are not eligible for traditional revascularization treatments. The primary endpoint is the severity of myocardial ischemia identified by sestamibi SPECT stress myocardial scintigraphy and the evaluation of adverse effect rates, while the secondary endpoints are evaluation of CCSAS and NYHA classification, regional myocardial blood flow as revealed by PET scan, and various left ventricular function indices. ;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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