Intracardiac CD133+ Cells in Patients With No-option Resistant Angina (RegentVsel)
|Stable Angina||Biological: intramyocardial injection (electromechanical mapping based) Biological: Placebo||Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Treatment
|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|
- Myocardial perfusion change [ Time Frame: 4 months after application of cell therapy ]Myocardial perfusion change assessed by perfusion scintigraphy (99mTc SPECT)
- Global and segmental contractility change and myocardial perfusion change [ Time Frame: 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
- Exercise tolerance [ Time Frame: 4 and 12 months after application of cell therapy ]Exercise tolerance assessed in a treadmill test (TET, ESTD, TTLA)
- Occurrence of symptomatic angina [ Time Frame: 1, 4, 6 and 12 months after application of cell therapy ]CCS, nitrates usage
- Quality of life [ Time Frame: 1, 4, 6 and 12 months after application of cell therapy ]Quality of life assessed by standard questionnaires: SF37, Seattle Angina
- Occurrence of ventricular arrhythmia [ Time Frame: 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 [ Time Frame: 4 months after application of cell therapy ]Assessed by Intravascular Ultrasound (IVUS) and Optical coherence tomography (OCT) examination
|Study Start Date:||June 2012|
|Estimated Study Completion Date:||December 2016|
|Estimated Primary Completion Date:||December 2016 (Final data collection date for primary outcome measure)|
intramyocardial injection (electromechanical mapping based) of autological CD133+ cells, isolated from bone marrow
Biological: intramyocardial 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.
Placebo Comparator: Placebo
intramyocardial injection (electromechanical mapping based) of placebo - 0,9% NaCl plus 0,5% solution of patients' serum
Patients in the placebo group receive 0.9% NaCl solution with 0.5% solution of the patient's own serum.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01660581
|Contact: Wojciech Wojakowski, MD, PhD||+48 32 firstname.lastname@example.org|
|Samodzielny Publiczny Szpital Kliniczny nr 7 Śląskiego Uniwersytetu Medycznego w Katowicach Górnośląskie Centrum Medyczne im. prof. Leszka Gieca||Recruiting|
|Katowice-Ochojec, Silesian, Poland, 40-635|
|Contact: Wojciech Wojakowski, MD, PhD +48 32 2523930 email@example.com|
|Principal Investigator: Wojciech Wojakowski, MD, PhD|
|Principal Investigator:||Wojciech Wojakowski, MD, PhD||Samodzielny Publiczny Szpital Kliniczny nr 7 Śląskiego Uniwersytetu Medycznego w Katowicach Górnośląskie Centrum Medyczne III Klinika Kardiologii|