Trial | NCT00694642  Report issue

Title

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

  • Phase

    Phase 1/Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    28
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 Started
May 31
2008
Primary Completion
May 31
2009
Study Completion
Feb 29
2012
Last Update
Aug 06
2013
Estimate

Biological Selected CD 133+ cells

Endothelial progenitor cell CD 133

selected CD133+cells Active Comparator

Transendocardial injection of selected CD133+cells

no injection No Intervention

Boths groups were treated with G-CSF, underwent an apheresis and NOGA mapping

Criteria 

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
No Results Posted