Ischemic Cardiomyopathy, Ischemic Heart Disease, Ischemic Heart Failure
Conditions
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.
Interventions
DRUGCellular Therapy (Cultured Autologous Skeletal Myoblast Transplantation)
Sponsors
Genzyme, a Sanofi Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Recovery of contractility within previously akinetic areas of the heart (areas without motion/contraction) that have received treatment (cells from the patient's thigh muscle or placebo), and change in left ventricular EF as assessed by echocardiography | — |
Secondary
| Measure | Time frame |
|---|---|
| Time-to-first major adverse cardiac event (cardiovascular related death, non-cardiovascular death, congestive heart failure, resuscitated sudden death, myocardial infarction (heart attack) and stroke. | — |
Countries
Belgium, France, Germany, Italy, Switzerland, United Kingdom
Outcome results
None listed