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

Sponsor

Pilar Jimenez Quevedo (Other)

Overall Status

Completed

CT.gov ID

NCT00694642

Collaborator

Fundación Mutua Madrileña (Other)

Enrollment

Location

Arms

Duration (Months)

0.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Coronary Artery Disease Refractory Angina	Biological: Selected CD 133+ cells	Phase 1/Phase 2

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 Design

Study Type:

Interventional

Actual Enrollment :

28 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

May 1, 2008

Actual Primary Completion Date :

May 1, 2009

Actual Study Completion Date :

Feb 1, 2012

Arms and Interventions

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

Arm

Intervention/Treatment

Active Comparator: selected CD133+cells

Transendocardial injection of selected CD133+cells

Biological: Selected CD 133+ cells

Endothelial progenitor cell CD 133

No Intervention: no injection

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

Outcome Measures

Primary Outcome Measures

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

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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital Clinico San Carlos	Madrid		Spain	28040

Sponsors and Collaborators

Pilar Jimenez Quevedo
Fundación Mutua Madrileña

Investigators

Principal Investigator: Pilar Jimenez-Quevedo, MD,PhD, Hostpial Clinico San Carlos

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Pilar Jimenez Quevedo, MD, PhD, Hospital San Carlos, Madrid

ClinicalTrials.gov Identifier:

NCT00694642

Other Study ID Numbers:

progenitorCD133

First Posted:

Jun 10, 2008

Last Update Posted:

Aug 6, 2013

Last Verified:

May 1, 2008

Keywords provided by Pilar Jimenez Quevedo, MD, PhD, Hospital San Carlos, Madrid

Refractory angina

Additional relevant MeSH terms:

Coronary Artery Disease

Study Results

No Results Posted as of Aug 6, 2013