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

Phase 1

Completed

• Conditions: Coronary Artery Disease; Refractory Angina
• Interventions: Biological: Selected CD 133+ cells

• Registration Number: NCT00694642
• Lead Sponsor: Pilar Jimenez Quevedo

Brief Summary

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

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 Timeline

• Status Verified: 2008-05
• Study Start: 2008-05
• Study First Submitted: 2008-06-05
• Study First Submitted QC: 2008-06-09
• Study First Posted: 2008-06-10
• Primary Completion: 2009-05
• Study Completion: 2012-02
• Last Update Submitted: 2013-08-04
• Last Update Posted: 2013-08-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
selected CD133+cells	Selected CD 133+ cells	Transendocardial injection of selected CD133+cells

Primary Outcome Measures

Name	Time	Method
major adverse cardiac and cerebrovascular event	6, 12 and 24 months	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).

Secondary Outcome Measures

Name	Time	Method
Efficacy	6 months	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)

Trial Locations

Locations (1)

Hospital Clinico San Carlos; 🇪🇸 Madrid, Spain