SMC00202: 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

This study has been terminated.

Sponsored By:	Genzyme
Information Provided By:	Genzyme
ClinicalTrials.gov Identifier:	NCT00102128

Purpose

The purpose of this study is to examine the safety and effectiveness of implanting skeletal muscle cells (cells removed from thigh muscle) into scarred areas of heart muscle after heart attack.

Condition	Intervention	Phase
Ischemic Heart Failure Ischemic Heart Disease Ischemic Cardiomyopathy	Drug: Cellular Therapy (Cultured Autologous Skeletal Myoblast Transplantation)	Phase II

Study Type: Interventional

Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Official Title: Evaluation of Skeletal Myoblast Transplant for Treating Ischemic Heart Failure

Further Study Details:
Primary Outcomes: 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 Outcomes: 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.

Study Start: 2002-11; Study Completion: 2008-03

Eligibility

Ages Eligible for Study: 18 Years - 80 Years, Genders Eligible for Study: Both

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

Location Information

Belgium
Aalst, Belgium
Brussels, Belgium
Gent, Belgium
Leuven, Belgium

France
Besancon, France
Bordeaux, France
Caen, France
Clermont-Ferrand, France
Grenoble, France
Lille, France
Lyon, France
Nantes, France
Paris, France
Rennes, France
Rouen, France
Toulouse, France

Germany
Bad Oeynhausen, Germany
Hamburg, Germany
Hannover, Germany

Italy
Bologna, Italy
Genova, Italy
Milano, Italy
Treviso, Italy
Udine, Italy

Switzerland
Lausanne, Switzerland

United Kingdom
Cambridge, United Kingdom
London, United Kingdom
Southampton, United Kingdom

More Information

Study ID Numbers: SMC00202
ClinicalTrials.gov Identifier: NCT00102128
Health Authority: France: Afssaps - French Health Products Safety Agency