Status:
TERMINATED
Treatment With Autologous Skeletal Myoblasts
Lead Sponsor:
Clinica Universidad de Navarra, Universidad de Navarra
Collaborating Sponsors:
Fina Biotech
Conditions:
Old Myocardial Infarction
Eligibility:
All Genders
30-80 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine the benefit of autologous skeletal myoblast injection in patients with old myocardial infarction and ventricular dysfunction versus conventional revascularisa...
Detailed Description
Ischaemic heart disease is one of the main causes of mortality and morbidity. In particular, myocardial infarction (MI) is of special significance, as the heart muscle cannot regenerate so a region's ...
Eligibility Criteria
Inclusion
- Patients with a diagnosis of coronary disease obtained by coronary angiography who require conventional aortocoronary bypass surgery.
- History of myocardial infarction with evidence of regional akinesis (or dyskinesia) for more than 4 weeks and less than 10 years.
- Ejection fraction from 25% to 45%.
- Evidence of no regional viability by dobutamine echocardiography.
- Aged from 30-80 years old.
- Negative serology to HIV, HBV and HCV.
- Patients without organ dysfunction.
- Negative pregnancy test (women of childbearing age).
- Informed consent granted.
Exclusion
- History of myocardial infarction in the 4 weeks prior to the inclusion in the study.
- Prior history of tachycardia or ventricular fibrillation (except in patients with DAI device).
- History of cancer (except basocellular carcinoma) or prior treatment with chemotherapy.
- The patient should not suffer from any concomitant severe and/or uncontrolled medical condition.
- Patients who, due to their geographical, psychiatric or social status, have difficulties in meeting the conditions established in the protocol.
- Pregnant or beast feeding women.
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2010
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT00975234
Start Date
May 1 2009
End Date
January 1 2010
Last Update
June 8 2012
Active Locations (6)
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1
Hospital Clínico Universitario de Santiago
Santiago de Compostela, Galicia, Spain, 15706
2
Hospital Gregorio Marañón
Madrid, Madrid, Spain, 28007
3
Hospital Clínico San Carlos
Madrid, Madrid, Spain, 28040
4
Clínica Universitaria de Navarra
Pamplona, Navarre, Spain, 31008