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.

May 21, 2015 updated by: Genzyme, a Sanofi Company

Evaluation of Skeletal Myoblast Transplant for Treating Ischemic Heart Failure

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Aalst, Belgium
        • Genzyme Corporation
      • Brussels, Belgium
        • Genzyme Corporation
      • Gent, Belgium
        • Genzyme Corporation
      • Leuven, Belgium
        • Genzyme Corporation
  • France
      • 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, France
        • Genzyme Corporation
  • Germany
      • Bad Oeynhausen, Germany
        • Genzyme Corporation
      • Hamburg, Germany
        • Genzyme Corporation
      • Hannover, Germany
        • Genzyme Corporation
  • Italy
      • Bologna, Italy
        • Genzyme Corporation
      • Genova, Italy
        • Genzyme Corporation
      • Milan, Italy
        • Genzyme Corporation
      • Treviso, Italy
        • Genzyme Corporation
      • Udine, Italy
        • Genzyme Corporation
  • Switzerland
      • Lausanne, Switzerland
        • Genzyme Corporation
  • United Kingdom
      • Cambridge, United Kingdom
        • Genzyme Corporation
      • London, United Kingdom
        • Genzyme Corporation
      • Southampton, United Kingdom
        • Genzyme Corporation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome 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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Genzyme, a Sanofi Company

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2002

Primary Completion (Actual)

April 1, 2007

Study Completion (Actual)

April 1, 2007

Study Registration Dates

First Submitted

January 21, 2005

First Submitted That Met QC Criteria

January 21, 2005

First Posted (Estimate)

January 24, 2005

Study Record Updates

Last Update Posted (Estimate)

May 22, 2015

Last Update Submitted That Met QC Criteria

May 21, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SMC00202

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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