Stable Angina Clinical Trial
Official title:
A Randomized,Prospective,Double-blind Study to Evaluate Intracardiac Injections of Bone Marrow,Autologous CD133+Cells(Electromechanical Mapping Based)in Patients With Resistant Angina and no Effective Revascularization Option. RegentVsel
The purpose of the study is to evaluate the efficacy of therapy with autological CD133+ cells in patients with angina resistant to pharmacological treatment and without the possibility of effective revascularization. Cells will be isolated from patients bone marrow and administered directly into the muscle of left ventricle. The main objective is to assess the treatments' influence on improvement of myocardial perfusion and function, and on decrease of occurrence of symptomatic angina.
Patients with a Stable angina pectoris (CCS II-IV) can potentially benefit from treatment
with autological CD133+ cell populations, which include cells with a higher expression of
cardiac and endothelial differentiation markers.
REGENT VSEL Trial will include Patients with Angina resistant to pharmacological treatment
and without the possibility of effective revascularization.
The main objective of the study is to assess the treatments influence on:
- improvement of myocardial perfusion
- global and segmental contractility (LVEF)
- occurrence of symptomatic angina
- quality of life
Regent Vsel is a prospective, randomized, double blind, placebo-controlled study with a
planned number of 60 Patients.
Randomization will be carried out according to a 1:1 mode. Every Patient will undergo a bone
marrow aspiration. CD133+ cells will be isolated from bone marrow aspirates. Patients
randomized to experimental group will receive isolated cells (direct left ventricular muscle
administration). Patients enrolled to control group will get only a placebo solution injected
into the muscle.
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