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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
31
Patient will undergo 3D electric and mechanical intracardiac mapping; based on maps generated intramyocardial administration of autologous CD133+ cells or placebo will be performed.
Patients in the placebo group receive 0.9% NaCl solution with 0.5% solution of the patient's own serum.
Samodzielny Publiczny Szpital Kliniczny nr 7 Śląskiego Uniwersytetu Medycznego w Katowicach Górnośląskie Centrum Medyczne im. prof. Leszka Gieca
Katowice-Ochojec, Silesian, Poland
Myocardial perfusion change
Myocardial perfusion change assessed by perfusion scintigraphy (99mTc SPECT)
Time frame: 4 months after application of cell therapy
Global and segmental contractility change and myocardial perfusion change
Global and segmental contractility change and myocardial perfusion change assessed by magnetic resonance imaging with adenosine administration, and echocardiography with contrast
Time frame: MRI 4 months and echocardiography 4 and 12 months after application of cell therapy
Exercise tolerance
Exercise tolerance assessed in a treadmill test (TET, ESTD, TTLA)
Time frame: 4 and 12 months after application of cell therapy
Occurrence of symptomatic angina
CCS, nitrates usage
Time frame: 1, 4, 6 and 12 months after application of cell therapy
Quality of life
Quality of life assessed by standard questionnaires: SF37, Seattle Angina
Time frame: 1, 4, 6 and 12 months after application of cell therapy
Occurrence of ventricular arrhythmia
24 hrs ECG monitoring
Time frame: 1, 4, 6 and 12 months after application of cell therapy
Occurrence of in-stent restenosis and progression of artherosclerotic lesions in remained coronary artery segments
Assessed by Intravascular Ultrasound (IVUS) and Optical coherence tomography (OCT) examination
Time frame: 4 months after application of cell therapy
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