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.
Sponsor:
Information provided by:
Genzyme, a Sanofi Company
ClinicalTrials.gov Identifier:
NCT00102128
First received: January 21, 2005
Last updated: August 3, 2009
Last verified: November 2006
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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 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
Estimated Study Completion Date: March 2008
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Medical Monitor, Genzyme Corporation
ClinicalTrials.gov Identifier: NCT00102128     History of Changes
Other Study ID Numbers: SMC00202
Study First Received: January 21, 2005
Last Updated: August 3, 2009
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

ClinicalTrials.gov processed this record on October 01, 2014