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

Coronary Artery Disease Clinical Trial

— PROGENITOR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00694642
• Other study ID #: progenitorCD133
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: June 5, 2008
• Last updated: August 4, 2013
• Start date: May 2008
• Est. completion date: February 2012

Study information

• Verified date: May 2008
• Source: Hospital San Carlos, Madrid
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: February 2012
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia
• Refractory Angina

Intervention

Biological:
• Selected CD 133+ cells
Endothelial progenitor cell CD 133

Locations

Country	Name	City	State
Spain	Hospital Clinico San Carlos	Madrid

Sponsors (2)

Lead Sponsor	Collaborator
Pilar Jimenez Quevedo	Fundación Mutua Madrileña

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	No