Stable Angina
Conditions
Keywords
CD133+, stem cells, Coronary Artery Disease, Stable Angina Pectoris
Brief summary
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.
Detailed description
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.
Interventions
BIOLOGICALintramyocardial injection (electromechanical mapping based)
Patient will undergo 3D electric and mechanical intracardiac mapping; based on maps generated intramyocardial administration of autologous CD133+ cells or placebo will be performed.
BIOLOGICALPlacebo
Patients in the placebo group receive 0.9% NaCl solution with 0.5% solution of the patient's own serum.
Sponsors
Medical University of Silesia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Stable angina CCS II-IV despite maximum pharmacotherapy for at least 2 weeks since last medications change 2. Presence of ≥ 1 myocardial segment with ischemia features in Tc-99m SPECT 3. Patients disqualified from revascularization procedures by Heart Team 4. Patient age \> 18 and \< 75 year old 5. Patient must provide written informed consent for participation in study
Exclusion criteria
1. Acute coronary syndrome in less than 6 months prior to enrollment 2. Heart failure NYHA III-IV 3. LVEF \<35% 4. Presence of intracardiac thrombus (echocardiography confirmed), massive calcification of the aortic valve and left ventricular aneurysm 5. Previous cardioverter-defibrillator or cardiac stimulator implantation 6. Allergy to contrast agents 7. History of malignancy 8. HIV, HBV, HCV infection 9. Life expectancy less than 6 months 10. Bleeding diathesis 11. Renal insufficiency (GFR \< 30 mL/min/1.73m2) 12. Pregnancy, lactation, or ineffective contraception in women of childbearing potential
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Myocardial perfusion change | 4 months after application of cell therapy | Myocardial perfusion change assessed by perfusion scintigraphy (99mTc SPECT) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Exercise tolerance | 4 and 12 months after application of cell therapy | Exercise tolerance assessed in a treadmill test (TET, ESTD, TTLA) |
| Occurrence of symptomatic angina | 1, 4, 6 and 12 months after application of cell therapy | CCS, nitrates usage |
| Global and segmental contractility change and myocardial perfusion change | MRI 4 months and echocardiography 4 and 12 months after application of cell therapy | Global and segmental contractility change and myocardial perfusion change assessed by magnetic resonance imaging with adenosine administration, and echocardiography with contrast |
| Occurrence of ventricular arrhythmia | 1, 4, 6 and 12 months after application of cell therapy | 24 hrs ECG monitoring |
| Occurrence of in-stent restenosis and progression of artherosclerotic lesions in remained coronary artery segments | 4 months after application of cell therapy | Assessed by Intravascular Ultrasound (IVUS) and Optical coherence tomography (OCT) examination |
| Quality of life | 1, 4, 6 and 12 months after application of cell therapy | Quality of life assessed by standard questionnaires: SF37, Seattle Angina |
Countries
Poland
Outcome results
None listed