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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00102128
Other study ID # SMC00202
Secondary ID
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


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.
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