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

This study has been completed.

Sponsor:

Collaborator:

Fundación Mutua Madrileña

Information provided by (Responsible Party):

Pilar Jimenez Quevedo, Hospital San Carlos, Madrid

ClinicalTrials.gov Identifier:

NCT00694642

First received: June 5, 2008

Last updated: August 4, 2013

Last verified: May 2008

History of Changes

Tracking Information

First Received Date ^ICMJE

June 5, 2008

Last Updated Date

August 4, 2013

Start Date ^ICMJE

May 2008

Primary Completion Date

May 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

major adverse cardiac and cerebrovascular event [ Time Frame: 6, 12 and 24 months ] [ Designated as safety issue: Yes ]

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).

Original Primary Outcome Measures ^ICMJE

Major adverse events [ Time Frame: 6, 12 and 24 months ] [ Designated as safety issue: Yes ]

Change History

Complete list of historical versions of study NCT00694642 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Efficacy [ Time Frame: 6 months ] [ Designated as safety issue: No ]

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)

Original Secondary Outcome Measures ^ICMJE

The change in the myocardial perfusion defect at baseline versus follow-up measured by Magnetic Resonance and Single Photon Emission Computed Tomography (SPECT) [ Time Frame: 6, 12 and 24 months ] [ Designated as safety issue: No ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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 Type ^ICMJE

Interventional

Study Phase

Phase 1
Phase 2

Study Design ^ICMJE

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

Condition ^ICMJE

Coronary Artery Disease
Refractory Angina

Intervention ^ICMJE

Biological: Selected CD 133+ cells

Endothelial progenitor cell CD 133

Study Arm (s)

Active Comparator: selected CD133+cells
Transendocardial injection of selected CD133+cells

Intervention: Biological: Selected CD 133+ cells
No Intervention: no injection
Boths groups were treated with G-CSF, underwent an apheresis and NOGA mapping

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

February 2012

Primary Completion Date

May 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 80 Years (Adult, Senior)

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

Spain

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT00694642

Other Study ID Numbers ^ICMJE

progenitorCD133

Has Data Monitoring Committee

Yes

Plan to Share Data

Not Provided

IPD Description

Not Provided

Responsible Party

Pilar Jimenez Quevedo, Hospital San Carlos, Madrid

Study Sponsor ^ICMJE

Pilar Jimenez Quevedo

Collaborators ^ICMJE

Fundación Mutua Madrileña

Investigators ^ICMJE

Principal Investigator:

Pilar Jimenez-Quevedo, MD,PhD

Hostpial Clinico San Carlos

Information Provided By

Hospital San Carlos, Madrid

Verification Date

May 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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