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 2

Terminated

• Conditions: Ischemic Heart Disease; Ischemic Cardiomyopathy; Ischemic Heart Failure

• Registration Number: NCT00102128
• Lead Sponsor: Genzyme, a Sanofi Company

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-11
• Study First Submitted: 2005-01-21
• Study First Submitted QC: 2005-01-21
• Study First Posted: 2005-01-24
• Primary Completion: 2007-04
• Study Completion: 2007-04
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-21
• Last Update Posted: 2015-05-22

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Genzyme Corporation; 🇬🇧 Southampton, United Kingdom