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	Treatment or Intervention	Phase
Ischemic Heart Disease Cardiomyopathies	Procedure: Cultured Autologous Skeletal Myoblast Transplantation	Phase II

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), 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.
Expected Total Enrollment:  300

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

Genzyme Corporation       request@clinicaltrialinformation.com

Belgium
      Genzyme Corporation, Aalst,  Belgium; Recruiting
      Genzyme Corporation, Brussels,  Belgium; Recruiting
      Genzyme Corporation, Gent,  Belgium; Recruiting
      Genzyme Corporation, Leuven,  Belgium; Recruiting
France
      Genzyme Corporation, Besancon,  France; Recruiting
      Genzyme Corporation, Bordeaux,  France; Recruiting
      Genzyme Corporation, Caen,  France; Recruiting
      Genzyme Corporation, Clermont-Ferrand,  France; Recruiting
      Genzyme Corporation, Grenoble,  France; Recruiting
      Genzyme Corporation, Lille,  France; Recruiting
      Genzyme Corporation, Lyon,  France; Recruiting
      Genzyme Corporation, Nantes,  France; Recruiting
      Genzyme Corporation, Paris,  France; Recruiting
      Genzyme Corporation, Rennes,  France; Recruiting
      Genzyme Corporation, Rouen,  France; Recruiting
      Genzyme Corporation, Toulouse,  France; Recruiting
Germany
      Genzyme Corporation, Bad Oeynhausen,  Germany; Recruiting
      Genzyme Corporation, Hamburg,  Germany; Recruiting
      Genzyme Corporation, Hannover,  Germany; Recruiting
Italy
      Genzyme Corporation, Bologna,  Italy; Recruiting
      Genzyme Corporation, Genova,  Italy; Recruiting
      Genzyme Corporation, Milano,  Italy; Recruiting
      Genzyme Corporation, Treviso,  Italy; Recruiting
      Genzyme Corporation, Udine,  Italy; Recruiting
Switzerland
      Genzyme Corporation, Lausanne,  Switzerland; Recruiting
United Kingdom
      Genzyme Corporation, Cambridge,  United Kingdom; Recruiting
      Genzyme Corporation, London,  United Kingdom; Recruiting
      Genzyme Corporation, Southampton,  United Kingdom; Recruiting

Study ID Numbers:  SMC00202
Record last reviewed:  January 2005
Last Updated:  January 24, 2005
Record first received:  January 21, 2005
ClinicalTrials.gov Identifier:  NCT00102128
Health Authority: France: Afssaps - French Health Products Safety Agency (Awaiting confirmation)
ClinicalTrials.gov processed this record on 2005-04-08