Intracardiac CD133+ Cells in Patients With No-option Resistant 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.

Inclusion criteria

• Stable angina CCS II-IV despite maximum pharmacotherapy for at least 2 weeks since last medications change
• Presence of ≥ 1 myocardial segment with ischemia features in Tc-99m SPECT
• Patients disqualified from revascularization procedures by Heart Team
• Patient age > 18 and < 75 year old
• Patient must provide written informed consent for participation in study

Exclusion criteria

• Acute coronary syndrome in less than 6 months prior to enrollment
• Heart failure NYHA III-IV
• LVEF <35%
• Presence of intracardiac thrombus (echocardiography confirmed), massive calcification of the aortic valve and left ventricular aneurysm
• Previous cardioverter-defibrillator or cardiac stimulator implantation
• Allergy to contrast agents
• History of malignancy
• HIV, HBV, HCV infection
• Life expectancy less than 6 months
• Bleeding diathesis
• Renal insufficiency (GFR < 30 mL/min/1.73m2)
• Pregnancy, lactation, or ineffective contraception in women of childbearing potential