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
Trial end date:
2007-04-01
Target enrollment:
0
Participant gender:
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 2
Accepts Healthy Volunteers?
No
Details
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