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.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00102128
Recruitment Status : Terminated (DMC recommended stop)
First Posted : January 24, 2005
Last Update Posted : May 22, 2015
Information provided by (Responsible Party):
Sanofi ( 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.

Condition or disease Intervention/treatment Phase
Ischemic Heart Failure Ischemic Heart Disease Ischemic Cardiomyopathy Drug: Cellular Therapy (Cultured Autologous Skeletal Myoblast Transplantation) Phase 2

Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Evaluation of Skeletal Myoblast Transplant for Treating Ischemic Heart Failure
Study Start Date : November 2002
Actual Primary Completion Date : April 2007
Actual Study Completion Date : April 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure
U.S. FDA Resources

Primary Outcome Measures :
  1. 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 :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00102128

Genzyme Corporation
Aalst, Belgium
Genzyme Corporation
Brussels, Belgium
Genzyme Corporation
Gent, Belgium
Genzyme Corporation
Leuven, Belgium
Genzyme Corporation
Besancon, France
Genzyme Corporation
Bordeaux, France
Genzyme Corporation
Caen, France
Genzyme Corporation
Clermont Ferrand, France
Genzyme Corporation
Grenoble, France
Genzyme Corporation
Lille, France
Genzyme Corporation
Lyon, France
Genzyme Corporation
Nantes, France
Genzyme Corporation
Paris, France
Genzyme Corporation
Rennes, France
Genzyme Corporation
Rouen, France
Genzyme Corporation
Toulouse, France
Genzyme Corporation
Bad Oeynhausen, Germany
Genzyme Corporation
Hamburg, Germany
Genzyme Corporation
Hannover, Germany
Genzyme Corporation
Bologna, Italy
Genzyme Corporation
Genova, Italy
Genzyme Corporation
Milan, Italy
Genzyme Corporation
Treviso, Italy
Genzyme Corporation
Udine, Italy
Genzyme Corporation
Lausanne, Switzerland
United Kingdom
Genzyme Corporation
Cambridge, United Kingdom
Genzyme Corporation
London, United Kingdom
Genzyme Corporation
Southampton, United Kingdom
Sponsors and Collaborators
Genzyme, a Sanofi Company
Study Director: Medical Monitor Genzyme, a Sanofi Company

Responsible Party: Genzyme, a Sanofi Company Identifier: NCT00102128     History of Changes
Other Study ID Numbers: SMC00202
First Posted: January 24, 2005    Key Record Dates
Last Update Posted: May 22, 2015
Last Verified: May 2015

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Myocardial Ischemia
Coronary Artery Disease
Cardiovascular Diseases
Pathologic Processes
Vascular Diseases
Coronary Disease
Arterial Occlusive Diseases