Overview
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.
Status:
Terminated
Terminated
Trial end date:
2007-04-01
2007-04-01
Target enrollment:
0
0
Participant gender:
All
All
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.Phase:
Phase 2Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Genzyme, a Sanofi Company
Criteria
Inclusion Criteria:- 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 Criteria:
- 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