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.

Sponsor

Genzyme, a Sanofi Company (Industry)

Overall Status

Terminated

CT.gov ID

NCT00102128

Collaborator

(none)

Locations

Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Ischemic Heart Failure Ischemic Heart Disease Ischemic Cardiomyopathy	Drug: Cellular Therapy (Cultured Autologous Skeletal Myoblast Transplantation)	Phase 2

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double

Primary Purpose:

Treatment

Official Title:

Evaluation of Skeletal Myoblast Transplant for Treating Ischemic Heart Failure

Study Start Date :

Nov 1, 2002

Actual Primary Completion Date :

Apr 1, 2007

Actual Study Completion Date :

Apr 1, 2007

Outcome Measures

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. []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	Country
1	Genzyme Corporation	Aalst	Belgium
2	Genzyme Corporation	Brussels	Belgium
3	Genzyme Corporation	Gent	Belgium
4	Genzyme Corporation	Leuven	Belgium
5	Genzyme Corporation	Besancon	France
6	Genzyme Corporation	Bordeaux	France
7	Genzyme Corporation	Caen	France
8	Genzyme Corporation	Clermont Ferrand	France
9	Genzyme Corporation	Grenoble	France
10	Genzyme Corporation	Lille	France
11	Genzyme Corporation	Lyon	France
12	Genzyme Corporation	Nantes	France
13	Genzyme Corporation	Paris	France
14	Genzyme Corporation	Rennes	France
15	Genzyme Corporation	Rouen	France
16	Genzyme Corporation	Toulouse	France
17	Genzyme Corporation	Bad Oeynhausen	Germany
18	Genzyme Corporation	Hamburg	Germany
19	Genzyme Corporation	Hannover	Germany
20	Genzyme Corporation	Bologna	Italy
21	Genzyme Corporation	Genova	Italy
22	Genzyme Corporation	Milan	Italy
23	Genzyme Corporation	Treviso	Italy
24	Genzyme Corporation	Udine	Italy
25	Genzyme Corporation	Lausanne	Switzerland
26	Genzyme Corporation	Cambridge	United Kingdom
27	Genzyme Corporation	London	United Kingdom
28	Genzyme Corporation	Southampton	United Kingdom