Autologous Cultured Myoblasts (BioWhittaker) Transplanted Via Myocardial Injection

Inclusion Criteria:

• Defined region of myocardial dysfunction related to previous myocardial infarctioninvolving the anterior, lateral, posterior or inferior walls, > 12 weeks old at thescheduled time of MyoCell™ implantation procedure

• Patients must have an implantable cardioverter defibrillator (ICD) in place or,patients must receive ICD placement during the CABG procedure or 3 to 4 days after theCABG procedure

• Planned CABG procedure for revascularization

• Heart failure patient in New York Heart Association Symptom Class 2 or 3 who is onoptimal medical therapy

• Age > 18 and < 80 years

• Able to undergo surgical biopsy of the skeletal muscle and successful culture of theharvested myoblasts

• Target region wall thickness > 6 mm by echocardiography

• Left ventricular ejection fraction > 20% and < 40% by radionuclide ventriculography orleft ventricular angiography at screening

• If a female of childbearing potential, urine pregnancy test must be negative

• Able to give written informed consent

Exclusion Criteria:

• Patient medically unable to undergo CABG surgery

• Any patient who has had a documented myocardial infarction (ECG changes or elevatedcardiac enzymes consistent with MI) within 30 days of the scheduled surgicalrevascularization and cellular implantation procedure.

• Known sensitivity to gentamicin sulfate and/or amphotericin-B

• Exposure to any investigational drug or procedure within 4 weeks prior to study entry

• The use or expected use of antineoplastic drugs

• History of skeletal muscle disease, either primary (i.e., myopathy) or secondary (i.e., ischemic) or any underlying myopathy such as myasthenia gravis, musculardystrophy, etc.) as determined by a board certified pathologist examining sample ofpatients muscle biopsy

• Previous angiogenic therapy and/or myocardial laser therapy

• History of cancer within 5 years, except for basal cell carcinoma of the skin

• PSA suggestive of carcinoma of the prostate (i.e., > 4)

• Patient with CEA >2.5 ng/mL or end stage renal disease

• Patients with active infectious disease and/or who are known to have tested positivefor HIV, HTLV, HBV-sAg, HCV, CMV and/or syphilis. If the panel includes antibodies tothe HBc and HBV-sAg, then an expert will be consulted.

• Females who are pregnant or nursing. Females of childbearing potential must be usingto the investigator's satisfaction, a medically accepted method of birth control (e.g., but not limited to, oral or implanted contraceptive therapy or intrauterinedevices) and agree to continue for the duration of the study.

• Any illness which might affect patient’s survival over the study follow-up period

• Any illness which, in the Investigator’s judgment, will interfere with the patient’sability to comply with the protocol, compromise patient safety, or interfere with theinterpretation of the study results.

• Patient with an any previous cardiac surgery

• Patient with valvular disease greater than mild in degree which is considered theprimary cause of their heart failure

• Patient in New York Heart Association Symptom Class 1 or 4

• Patient with serum creatinine > 2.5

• No informed consent or unable to provide informed consent