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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.

Primary Purpose

Ischemic Heart Failure, Ischemic Heart Disease, Ischemic Cardiomyopathy

Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Cellular Therapy (Cultured Autologous Skeletal Myoblast Transplantation)
Sponsored by
Genzyme, a Sanofi Company
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ischemic Heart Failure

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Genzyme Corporation
  • Genzyme Corporation
  • Genzyme Corporation
  • Genzyme Corporation
  • Genzyme Corporation
  • Genzyme Corporation
  • Genzyme Corporation
  • Genzyme Corporation
  • Genzyme Corporation
  • Genzyme Corporation
  • Genzyme Corporation
  • Genzyme Corporation
  • Genzyme Corporation
  • Genzyme Corporation
  • Genzyme Corporation
  • Genzyme Corporation
  • Genzyme Corporation
  • Genzyme Corporation
  • Genzyme Corporation
  • Genzyme Corporation
  • Genzyme Corporation
  • Genzyme Corporation
  • Genzyme Corporation
  • Genzyme Corporation
  • Genzyme Corporation
  • Genzyme Corporation
  • Genzyme Corporation
  • Genzyme Corporation

Outcomes

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.

Full Information

First Posted
January 21, 2005
Last Updated
May 21, 2015
Sponsor
Genzyme, a Sanofi Company
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1. Study Identification

Unique Protocol Identification Number
NCT00102128
Brief Title
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

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Terminated
Why Stopped
DMC recommended stop
Study Start Date
November 2002 (undefined)
Primary Completion Date
April 2007 (Actual)
Study Completion Date
April 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Genzyme, a Sanofi Company

4. Oversight

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Heart Failure, Ischemic Heart Disease, Ischemic Cardiomyopathy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Cellular Therapy (Cultured Autologous Skeletal Myoblast Transplantation)
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Genzyme, a Sanofi Company
Official's Role
Study Director
Facility Information:
Facility Name
Genzyme Corporation
City
Aalst
Country
Belgium
Facility Name
Genzyme Corporation
City
Brussels
Country
Belgium
Facility Name
Genzyme Corporation
City
Gent
Country
Belgium
Facility Name
Genzyme Corporation
City
Leuven
Country
Belgium
Facility Name
Genzyme Corporation
City
Besancon
Country
France
Facility Name
Genzyme Corporation
City
Bordeaux
Country
France
Facility Name
Genzyme Corporation
City
Caen
Country
France
Facility Name
Genzyme Corporation
City
Clermont Ferrand
Country
France
Facility Name
Genzyme Corporation
City
Grenoble
Country
France
Facility Name
Genzyme Corporation
City
Lille
Country
France
Facility Name
Genzyme Corporation
City
Lyon
Country
France
Facility Name
Genzyme Corporation
City
Nantes
Country
France
Facility Name
Genzyme Corporation
City
Paris
Country
France
Facility Name
Genzyme Corporation
City
Rennes
Country
France
Facility Name
Genzyme Corporation
City
Rouen
Country
France
Facility Name
Genzyme Corporation
City
Toulouse
Country
France
Facility Name
Genzyme Corporation
City
Bad Oeynhausen
Country
Germany
Facility Name
Genzyme Corporation
City
Hamburg
Country
Germany
Facility Name
Genzyme Corporation
City
Hannover
Country
Germany
Facility Name
Genzyme Corporation
City
Bologna
Country
Italy
Facility Name
Genzyme Corporation
City
Genova
Country
Italy
Facility Name
Genzyme Corporation
City
Milan
Country
Italy
Facility Name
Genzyme Corporation
City
Treviso
Country
Italy
Facility Name
Genzyme Corporation
City
Udine
Country
Italy
Facility Name
Genzyme Corporation
City
Lausanne
Country
Switzerland
Facility Name
Genzyme Corporation
City
Cambridge
Country
United Kingdom
Facility Name
Genzyme Corporation
City
London
Country
United Kingdom
Facility Name
Genzyme Corporation
City
Southampton
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

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.

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