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

This study has been completed.
Sponsor:
Collaborator:
Grant from the Spanish Heath Ministry and Fundacion de Mutual 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

June 5, 2008
August 4, 2013
May 2008
May 2009   (final data collection date for primary outcome measure)
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).
Major adverse events [ Time Frame: 6, 12 and 24 months ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00694642 on ClinicalTrials.gov Archive Site
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)
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 ]
Not Provided
Not Provided
 
Safety and Efficacy of Autologous Endothelial Progenitor Cell CD 133 for Therapeutic Angiogenesis
Safety and Efficacy of Transendocardial Injection of Autologous Endothelial Progenitor Cell CD 133 for Therapeutics Angiogenesis

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.

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.

Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
  • Coronary Artery Disease
  • Refractory Angina
Biological: Selected CD 133+ cells
Endothelial progenitor cell CD 133
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
28
February 2012
May 2009   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT00694642
progenitorCD133
Yes
Pilar Jimenez Quevedo, Hospital San Carlos, Madrid
Pilar Jimenez Quevedo
Grant from the Spanish Heath Ministry and Fundacion de Mutual Madrileña.
Principal Investigator: Pilar Jimenez-Quevedo, MD,PhD Hostpial Clinico San Carlos
Hospital San Carlos, Madrid
May 2008

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