Status:
COMPLETED
Safety and Efficacy of Autologous Endothelial Progenitor Cell CD 133 for Therapeutic Angiogenesis
Lead Sponsor:
Pilar Jimenez Quevedo
Collaborating Sponsors:
Fundación Mutua Madrileña
Conditions:
Coronary Artery Disease
Refractory Angina
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
PHASE2
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.
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 SPEC...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2012
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT00694642
Start Date
May 1 2008
End Date
February 1 2012
Last Update
August 6 2013
Active Locations (1)
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1
Hospital Clinico San Carlos
Madrid, Madrid, Spain, 28040