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

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ClinicalTrials.gov Identifier: NCT00694642
Recruitment Status : Completed
First Posted : June 10, 2008
Last Update Posted : August 6, 2013
Sponsor:
Collaborator:
Information provided by (Responsible Party):

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  (Clinical Trial)
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 2008
Primary Completion Date : May 2009
Study Completion Date : February 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Angina
U.S. FDA Resources

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


Outcome Measures

Primary Outcome Measures :
  1. major adverse cardiac and cerebrovascular event [ Time Frame: 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 :
  1. Efficacy [ Time Frame: 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00694642


Locations
Spain
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
More Information

Responsible Party: Pilar Jimenez Quevedo, MD, PhD, Hospital San Carlos, Madrid
ClinicalTrials.gov Identifier: NCT00694642     History of Changes
Other Study ID Numbers: progenitorCD133
First Posted: June 10, 2008    Key Record Dates
Last Update Posted: August 6, 2013
Last Verified: May 2008

Keywords provided by Pilar Jimenez Quevedo, Hospital San Carlos, Madrid:
Refractory angina

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases