Intracardiac CD133+ Cells in Patients With No-option Resistant Angina (RegentVsel)
|ClinicalTrials.gov Identifier: NCT01660581|
Recruitment Status : Completed
First Posted : August 8, 2012
Last Update Posted : September 28, 2017
|Condition or disease||Intervention/treatment||Phase|
|Stable Angina||Biological: intramyocardial injection (electromechanical mapping based) Biological: Placebo||Phase 2|
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 (Clinical Trial)|
|Actual Enrollment :||31 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|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|
|Study Start Date :||June 2012|
|Primary Completion Date :||September 2016|
|Study Completion Date :||September 2016|
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.
- 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01660581
|Samodzielny Publiczny Szpital Kliniczny nr 7 Śląskiego Uniwersytetu Medycznego w Katowicach Górnośląskie Centrum Medyczne im. prof. Leszka Gieca|
|Katowice-Ochojec, Silesian, Poland, 40-635|
|Principal Investigator:||Wojciech Wojakowski, MD, PhD||Samodzielny Publiczny Szpital Kliniczny nr 7 Śląskiego Uniwersytetu Medycznego w Katowicach Górnośląskie Centrum Medyczne III Klinika Kardiologii|