NCT00102128

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Nov 2002

Typical duration for phase_2

Geographic Reach
6 countries

28 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2002

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

January 21, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 24, 2005

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2007

Completed
Last Updated

May 22, 2015

Status Verified

May 1, 2015

Enrollment Period

4.4 years

First QC Date

January 21, 2005

Last Update Submit

May 21, 2015

Conditions

Ischemic Heart FailureIschemic Heart DiseaseIschemic Cardiomyopathy

Outcome Measures

Primary Outcomes (1)

  • 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 (1)

  • 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.

Interventions

Cellular Therapy (Cultured Autologous Skeletal Myoblast Transplantation)DRUG

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (28)

Genzyme Corporation

Aalst, Belgium

Location

Genzyme Corporation

Brussels, Belgium

Location

Genzyme Corporation

Ghent, Belgium

Location

Genzyme Corporation

Leuven, Belgium

Location

Genzyme Corporation

Besançon, France

Location

Genzyme Corporation

Bordeaux, France

Location

Genzyme Corporation

Caen, France

Location

Genzyme Corporation

Clermont-Ferrand, France

Location

Genzyme Corporation

Grenoble, France

Location

Genzyme Corporation

Lille, France

Location

Genzyme Corporation

Lyon, France

Location

Genzyme Corporation

Nantes, France

Location

Genzyme Corporation

Paris, France

Location

Genzyme Corporation

Rennes, France

Location

Genzyme Corporation

Rouen, France

Location

Genzyme Corporation

Toulouse, France

Location

Genzyme Corporation

Bad Oeynhausen, Germany

Location

Genzyme Corporation

Hamburg, Germany

Location

Genzyme Corporation

Hanover, Germany

Location

Genzyme Corporation

Bologna, Italy

Location

Genzyme Corporation

Genova, Italy

Location

Genzyme Corporation

Milan, Italy

Location

Genzyme Corporation

Treviso, Italy

Location

Genzyme Corporation

Udine, Italy

Location

Genzyme Corporation

Lausanne, Switzerland

Location

Genzyme Corporation

Cambridge, United Kingdom

Location

Genzyme Corporation

London, United Kingdom

Location

Genzyme Corporation

Southampton, United Kingdom

Location

MeSH Terms

Conditions

Myocardial Ischemia

Interventions

Cell- and Tissue-Based Therapy

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

Biological TherapyTherapeutics

Study Officials

  • Medical Monitor

    Genzyme, a Sanofi Company

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 21, 2005

First Posted

January 24, 2005

Study Start

November 1, 2002

Primary Completion

April 1, 2007

Study Completion

April 1, 2007

Last Updated

May 22, 2015

Record last verified: 2015-05

Locations

BE(4)CH(1)DE(3)IT(5)GB(3)FR(12)