Clinical trial NCT00102128: 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.
Official title: Evaluation of Skeletal Myoblast Transplant for Treating Ischemic Heart Failure
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Ischemic Heart Failure
Ischemic Heart Disease
Ischemic Cardiomyopathy
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2005-01-24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: 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 outcomes:
measure: 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.
Other outcomes:
Locations:
city: Aalst
country: Belgium
facility: Genzyme Corporation
city: Brussels
country: Belgium
facility: Genzyme Corporation
city: Gent
country: Belgium
facility: Genzyme Corporation
city: Leuven
country: Belgium
facility: Genzyme Corporation
city: Besancon
country: France
facility: Genzyme Corporation
city: Bordeaux
country: France
facility: Genzyme Corporation
city: Caen
country: France
facility: Genzyme Corporation
city: Clermont Ferrand
country: France
facility: Genzyme Corporation
city: Grenoble
country: France
facility: Genzyme Corporation
city: Lille
country: France
facility: Genzyme Corporation
city: Lyon
country: France
facility: Genzyme Corporation
city: Nantes
country: France
facility: Genzyme Corporation
city: Paris
country: France
facility: Genzyme Corporation
city: Rennes
country: France
facility: Genzyme Corporation
city: Rouen
country: France
facility: Genzyme Corporation
city: Toulouse
country: France
facility: Genzyme Corporation
city: Bad Oeynhausen
country: Germany
facility: Genzyme Corporation
city: Hamburg
country: Germany
facility: Genzyme Corporation
city: Hannover
country: Germany
facility: Genzyme Corporation
city: Bologna
country: Italy
facility: Genzyme Corporation
city: Genova
country: Italy
facility: Genzyme Corporation
city: Milan
country: Italy
facility: Genzyme Corporation
city: Treviso
country: Italy
facility: Genzyme Corporation
city: Udine
country: Italy
facility: Genzyme Corporation
city: Lausanne
country: Switzerland
facility: Genzyme Corporation
city: Cambridge
country: United Kingdom
facility: Genzyme Corporation
city: London
country: United Kingdom
facility: Genzyme Corporation
city: Southampton
country: United Kingdom
facility: Genzyme Corporation
Study officials:
affiliation: Genzyme, a Sanofi Company
name: Medical Monitor
role: STUDY_DIRECTOR
References: