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.

Genzyme

Status and phase

Terminated

Phase 2

Conditions

Ischemic Heart Disease

Ischemic Cardiomyopathy

Ischemic Heart Failure

Treatments

Drug: Cellular Therapy (Cultured Autologous Skeletal Myoblast Transplantation)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00102128

SMC00202

Details and patient eligibility

About

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.

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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