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.

Ischemic Heart Disease Clinical Trial

Official title:

Evaluation of Skeletal Myoblast Transplant for Treating Ischemic Heart Failure

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00102128
• Other study ID #: SMC00202
• Status: Terminated
• Phase: Phase 2
• First received: January 21, 2005
• Last updated: May 21, 2015
• Start date: November 2002
• Est. completion date: April 2007

Study information

• Verified date: May 2015
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 0
• Est. completion date: April 2007
• Est. primary completion date: April 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cardiomyopathies
• Coronary Artery Disease
• Heart Failure
• Ischemia
• Ischemic Cardiomyopathy
• Ischemic Heart Disease
• Ischemic Heart Failure
• Myocardial Ischemia

Intervention

Drug:
• Cellular Therapy (Cultured Autologous Skeletal Myoblast Transplantation)

Locations

Country	Name	City	State
Belgium	Genzyme Corporation	Aalst
Belgium	Genzyme Corporation	Brussels
Belgium	Genzyme Corporation	Gent
Belgium	Genzyme Corporation	Leuven
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
Germany	Genzyme Corporation	Bad Oeynhausen
Germany	Genzyme Corporation	Hamburg
Germany	Genzyme Corporation	Hannover
Italy	Genzyme Corporation	Bologna
Italy	Genzyme Corporation	Genova
Italy	Genzyme Corporation	Milan
Italy	Genzyme Corporation	Treviso
Italy	Genzyme Corporation	Udine
Switzerland	Genzyme Corporation	Lausanne
United Kingdom	Genzyme Corporation	Cambridge
United Kingdom	Genzyme Corporation	London
United Kingdom	Genzyme Corporation	Southampton

Sponsors (1)

Lead Sponsor	Collaborator
Genzyme, a Sanofi Company

Countries where clinical trial is conducted

Belgium,  France,  Germany,  Italy,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.