The purpose of this study is to determine whether transendocardial injections of autologous endothelial progenitor cells CD 133 is safe and feasible in patients with refractory angina.
The PROGENITOR trial is a randomized, double-blinded, multicenter controlled trial including patients with Canadian cardiovascular society angina classification (CCS): II-IV and ischemic zones by SPECT but without any option for revascularization. Primary endpoint was to assess the safety and feasibility of transendocardial injection of selected CD133+cells. All patients were treated for 4-days with granulocyte colony-stimulating factor and underwent apheresis. CD133+ cells were selected with CliniMacs system and were injected transendocardially guided by the NOGA XP system.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
28
Endothelial progenitor cell CD 133
Hospital Clinico San Carlos
Madrid, Madrid, Spain
major adverse cardiac and cerebrovascular event
cardiovascular death, non-fatal myocardial infarction (MI), ischemic stroke, need for revascularization or , procedure-related complications (: pericardial effusion/cardiac tamponade, vascular complications and sustained ventricular arrhythmias).
Time frame: 6, 12 and 24 months
Efficacy
The change in the myocardial perfusion defect at baseline versus follow-up measured by Single Photon Emission Computed Tomography (SPECT). Treadmill test, and clinical evaluation (CCS, nº angina episodes/month, nº nitroglycerin /month, Quality of life by seattle questionnaire)
Time frame: 6 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.