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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Coronary Artery Disease, Refractory Angina

Intervention / Treatment
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* Biological: Selected CD 133+ cells


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: selected CD133+cells<br>Transendocardial injection of selected CD133+cells | Biological: Selected CD 133+ cells<br>* Endothelial progenitor cell CD 133<br>|
| No Intervention: no injection<br>Boths groups were treated with G-CSF, underwent an apheresis and NOGA mapping | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 6, 12 and 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Refractory angina