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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2008 by Hospital San Carlos, Madrid.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Hospital San Carlos, Madrid
ClinicalTrials.gov Identifier:
NCT00694642
First received: June 5, 2008
Last updated: June 9, 2008
Last verified: May 2008
History of Changes
  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: Stem cell (Endothelial progenitor cell CD 133)
Biological: Placebo
 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:

U.S. FDA Resources

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

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

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 30
Study Start Date: May 2008
Estimated Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A Biological: Stem cell (Endothelial progenitor cell CD 133)
Endothelial progenitor cell CD 133
Placebo Comparator: B Biological: Placebo
Placebo

  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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00694642

Contacts
Contact: Pilar Jimenez Quevedo, MD 34-9-1330-3283 pjimenez.hcsc@salud.madrid.org
Contact: Manel Sabate, MD 34-9-3556-5851 msabatet@santpau.cat

Locations
Spain
Hospital Clinico San Carlos Recruiting
Madrid, Spain, 28040
Contact: Pilar Jimenez Quevedo, MD     34-9-1330-3283     pjimenez.hcsc@salud.madrid.org    
Contact: Manel Sabate, MD     34-9-3556-5851     msabatet@santpau.cat    
Principal Investigator: Pilar Jimenez Quevedo, MD            
Sponsors and Collaborators
Hospital San Carlos, Madrid
  More Information

No publications provided

Responsible Party: Pilar Jimenez Quevedo, Hospital Clinico San Carlos
ClinicalTrials.gov Identifier: NCT00694642     History of Changes
Other Study ID Numbers: progenitorCD133
Study First Received: June 5, 2008
Last Updated: June 9, 2008
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 June 18, 2013