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
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Transendocardial Injection of Autologous Endothelial Progenitor Cell CD 133 for Therapeutics Angiogenesis

Resource links provided by NLM:


Further study details as provided by Hospital San Carlos, Madrid:

Primary Outcome Measures:
  • 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).


Secondary Outcome Measures:
  • 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)


Enrollment: 28
Study Start Date: May 2008
Study Completion Date: February 2012
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Pilar Jimenez Quevedo, MD, PhD, Hospital San Carlos, Madrid
ClinicalTrials.gov Identifier: NCT00694642     History of Changes
Other Study ID Numbers: progenitorCD133
Study First Received: June 5, 2008
Last Updated: August 4, 2013
Health Authority: Spain: Spanish Agency of Medicines

Keywords provided by 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

ClinicalTrials.gov processed this record on July 22, 2014