Safety and Efficacy of Autologous Endothelial Progenitor Cell CD 133 for Therapeutic Angiogenesis

Safety and Efficacy of Transendocardial Injection of Autologous Endothelial Progenitor Cell CD 133 for Therapeutics Angiogenesis

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.

Inclusion Criteria:

• Functional class II- IV angina on maximal medical therapy
• Myocardial Ischemia/viability demonstrated by a reversible perfusion defect by means imaging techniques
• Patients should not be amenable to any type of revascularization procedure (percutaneous or surgical)
• Signed informed consent

Exclusion Criteria:

• Age <18 years or >75 years.
• Atrial fibrillation.
• LV thrombus
• Acute myocardial infarction in the last 3 months
• An LV wall thickness of <8 mm at the target site for cell injection
• A history of malignancy in the last 5 years