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 Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2002-11-30

Study Completion Date

2007-04-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Ischemic Heart Failure Ischemic Heart Disease Ischemic Cardiomyopathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Cellular Therapy (Cultured Autologous Skeletal Myoblast Transplantation)

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No