Autologous Cultured Myoblasts (BioWhittaker) Transplanted Via Myocardial Injection
Congestive Heart Failure, Coronary Artery Disease, Myocardial Infarction
About this trial
This is an interventional treatment trial for Congestive Heart Failure focused on measuring Myocardial Infarction, Heart disease, Coronary bypass graft (CABG) surgery, Implantable Cardioverter Defibrillator (ICD), CABG, ICD, Heart failure
Eligibility Criteria
Inclusion Criteria: Defined region of myocardial dysfunction related to previous myocardial infarction involving the anterior, lateral, posterior or inferior walls, > 12 weeks old at the scheduled 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 the CABG procedure Planned CABG procedure for revascularization Heart failure patient in New York Heart Association Symptom Class 2 or 3 who is on optimal medical therapy Age > 18 and < 80 years Able to undergo surgical biopsy of the skeletal muscle and successful culture of the harvested myoblasts Target region wall thickness > 6 mm by echocardiography Left ventricular ejection fraction > 20% and < 40% by radionuclide ventriculography or left 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 elevated cardiac enzymes consistent with MI) within 30 days of the scheduled surgical revascularization 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, muscular dystrophy, etc.) as determined by a board certified pathologist examining sample of patients 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 positive for HIV, HTLV, HBV-sAg, HCV, CMV and/or syphilis. If the panel includes antibodies to the HBc and HBV-sAg, then an expert will be consulted. Females who are pregnant or nursing. Females of childbearing potential must be using to the investigator's satisfaction, a medically accepted method of birth control (e.g., but not limited to, oral or implanted contraceptive therapy or intrauterine devices) 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's ability to comply with the protocol, compromise patient safety, or interfere with the interpretation of the study results. Patient with an any previous cardiac surgery Patient with valvular disease greater than mild in degree which is considered the primary 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
Sites / Locations
- Bioheart, Inc
- ACRI
- Rush-Presbyterian-St. Luke's Medical Center
- Mt. Sinai Medical Center
- Duke University