ICH GCP | Clinical Trials Registry

Bioheart, Inc. 

Patients who meet all of the following inclusion criteria and none of the exclusion criteria will be enrolled in this clinical study. Inclusion Criteria: - Defined region of myocardial dysfunction related to previous myocardial infarction(s) involving the anterior, lateral, posterior or inferior walls, > 12 weeks (84 days) old at the scheduled time of MyoCell™ implantation - Patients who have had prior placement of an Implantable Cardioverter Defibrillator (ICD) which must be in place at least one month (30 days) prior to MyoCell™ implantation - New York Heart Association (NYHA) Symptom Class II or III on optimal medical therapy - Age > 30 and < 80 years old - Need for revascularization has been ruled out by coronary angiogram or noninvasive stress testing within six months (180 days) of screening - 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 - Able to give written informed consent - Able to walk a minimum distance of 300 meters during the 6-minute walk test Exclusion Criteria: - Myocardial infarction within 12 weeks (84 days) prior to investigational procedure - New York Heart Association Symptom Class I or IV - Coronary Artery Bypass Grafting (CABG) within 3 months (90 days) prior to scheduled MyoCell™ implantation - Percutaneous Coronary Intervention (PCI) within 6 months (180 days) prior to MyoCell™ implantation - Canadian Heart Classification of angina > Class II or unstable angina - Any cardiac valve replacement - Heart failure secondary to valvular disease - Aortic stenosis greater than mild degree - Left ventricular or atrial mural thrombus - Chronic pulmonary disease - Atherosclerosis and/or tortuosity of the aorta, iliac or femoral arteries of a degree which, in the judgment of the principal investigator, would impede or preclude the safe retrograde passage of the 8FR MyoCath™ delivery catheter - History of severe radiocontrast reaction - Known sensitivity to gentamicin sulfate and/or amphotericin-B - Previous angiogenic therapy and/or myocardial laser therapy - Exposure to any investigational drug or procedure within 1 month prior to study entry - The use or expected use of antineoplastic drugs or history of cancer within 5 years, except for basal cell carcinoma of the skin - 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 - Serum creatinine > 2.5 mg/dL or end stage renal disease - Prostate Specific Antigen (PSA) suggestive of carcinoma of the prostate (i.e., > 4.0 ng/mL) - Carcinoembryonic Antigen (CEA) >5.0 ng/mL or end stage renal disease - 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 as to patient eligibility based on the patient's infectious status - Females who are pregnant or nursing - Females of childbearing potential who are unwilling to maintain contraceptive therapy for the duration of the study - Morbid obesity - more than 100 pounds over ideal body weight or Body Mass Index (BMI) > 40 - Any illness which might affect patient's survival over the study 12 month 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 - No written Informed Consent or unable to provide informed consent

All

30 Years

80 Years

No

United States

Non-Randomized

Single Group Assignment

Treatment

None (Open Label)