We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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.
(DMC recommended stop)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00102128
First Posted: January 24, 2005
Last Update Posted: May 22, 2015
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.
Information provided by (Responsible Party):
Sanofi ( Genzyme, a Sanofi Company )
  Purpose
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 Intervention Phase
Ischemic Heart Failure Ischemic Heart Disease Ischemic Cardiomyopathy Drug: Cellular Therapy (Cultured Autologous Skeletal Myoblast Transplantation) Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Evaluation of Skeletal Myoblast Transplant for Treating Ischemic Heart Failure

Resource links provided by NLM:


Further study details as provided by Sanofi ( Genzyme, a Sanofi Company ):

Primary Outcome Measures:
  • 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:
  • 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 Date: November 2002
Study Completion Date: April 2007
Primary Completion Date: April 2007 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00102128


Locations
Belgium
Genzyme Corporation
Aalst, Belgium
Genzyme Corporation
Brussels, Belgium
Genzyme Corporation
Gent, Belgium
Genzyme Corporation
Leuven, Belgium
France
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
Germany
Genzyme Corporation
Bad Oeynhausen, Germany
Genzyme Corporation
Hamburg, Germany
Genzyme Corporation
Hannover, Germany
Italy
Genzyme Corporation
Bologna, Italy
Genzyme Corporation
Genova, Italy
Genzyme Corporation
Milan, Italy
Genzyme Corporation
Treviso, Italy
Genzyme Corporation
Udine, Italy
Switzerland
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
Investigators
Study Director: Medical Monitor Genzyme, a Sanofi Company
  More Information

Responsible Party: Genzyme, a Sanofi Company
ClinicalTrials.gov Identifier: NCT00102128     History of Changes
Other Study ID Numbers: SMC00202
First Submitted: January 21, 2005
First Posted: January 24, 2005
Last Update Posted: May 22, 2015
Last Verified: May 2015

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