Status:
TERMINATED
Study to Examine the Safety and Effectiveness of Implanted Skeletal Muscle Cells (Cells Removed From the Thigh Muscle) Into Scarred Areas of Heart Muscle After Heart Attack.
Lead Sponsor:
Genzyme, a Sanofi Company
Conditions:
Ischemic Heart Failure
Ischemic Heart Disease
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
Study to examine the safety and effectiveness of implanted skeletal muscle cells (cells removed from the thigh muscle) into scarred areas of heart muscle after heart attack.
Eligibility Criteria
Inclusion
- Patients recommended for coronary bypass surgery (preferably with cardiopulmonary support)
- Ejection fraction ≥15% and ≤35%
- Left ventricular myocardial infarction (MI - heart attack) ≥4 weeks prior to screening
Exclusion
- Need for a rapid surgical coronary revascularization
- Need for any other related cardiosurgical measure during coronary surgery (e.g. mitral valve repair or valve replacement)
- Patients with a left ventricular aneurysm who is a candidate for left ventricular aneurysmectomy or left ventricular reduction surgery; patient receiving left or biventricular (BiV) pacing therapy for heart failure (unless the patient has stabilized after 6 or more months of this therapy)
- Cardiomyopathy presumed to be of non-ischemic origin
Key Trial Info
Start Date :
November 1 2002
Trial Type :
INTERVENTIONAL
End Date :
April 1 2007
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00102128
Start Date
November 1 2002
End Date
April 1 2007
Last Update
May 22 2015
Active Locations (28)
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1
Genzyme Corporation
Aalst, Belgium
2
Genzyme Corporation
Brussels, Belgium
3
Genzyme Corporation
Ghent, Belgium
4
Genzyme Corporation
Leuven, Belgium