Use of Ixmyelocel-T (Formerly Catheter-based Cardiac Repair Cell [CRC]) Treatment in Patients With Heart Failure Due to Dilated Cardiomyopathy

Exclusion Criteria

• •Severe primary valvular heart disease including, but not limited to, aortic valve stenosis and insufficiency.
• •Known history of COPD defined as Gold stage IIB (FEV1/FVC\<70% with 30%\</=FEV1\<50% predicted, with or without chronic symptoms of cough, sputum production, dyspnea) or more severe or restrictive pulmonary disease.
• •Known history of primary pulmonary hypertension.
• •VAD implantation.
• •Myocardial infarction within 4 weeks prior to randomization.
• •History of life-threatening ventricular arrhythmia, except if an AICD is implanted.
• •Unstable angina, characterized by increasingly frequent episodes with modest exertion or at rest, worsening severity, and prolonged duration.
• •Patients at high risk for complications due to injection procedure (e.g. patients who have severe peripheral atherosclerotic disease that does not allow advancement of the catheter; patients who have a prosthetic aortic or mitral valve; patients who have a LV thrombus or aneurysm; patients who have an aortic dissection or aneurysm, etc.).
• •Patients w/poorly controlled diabetes mellitus (HbAlc\>9.0%).
• •Patients receiving treatment with hematopoietic growth factors (e.g. EPO, G-CSF).
• •Patients who require uninterruptible anticoagulation therapy (e.g. warfarin)that cannot be stopped for 72 hours prior to bone marrow aspiration and intramyocardial injections; OR patients receiving anti-platelet therapy (e.g. clopidogrel) that cannot be stopped for 7 days prior to bone marrow aspiration and transendocardial injections, unless contraindicated.
• •Known cancer and undergoing treatment including chemotherapy and radiation.
• •Patients requiring continuous, systemic, high dose corticosteroid therapy (more than 7.5 mg/day) within 1 month before aspiration or 6 months after injection procedure.
• •End stage renal disease requiring dialysis.
• •Patients pregnant or lactating; positive for hCG
• •History of alcohol consumption regularly exceeding the equivalent of 2 drinks/day (1 drink = 5 oz of wine or 12 oz \[360mL\] of beer or 1.5 oz \[45mL\]) of hard liquor or history of illicit drug use w/in 6 months of screening.
• •Known allergies to protein products (horse or bovine serum, or porcine trypsin) used in the ex-vivo cell production process.
• •BMI of 40 Kg/m2 or greater.
• •Patients receiving experimental medications or participating in another clinical study within 30 days of screening.
• •HIV or syphilis, positive at time of screening.
• •Active Hepatitis B or Hepatitis C infection at the time of screening.
• •Patient determined unsuitable for cellular therapy, in the opinion of the investigator or sponsor.
• •Patients receiving anti-angiogenic drugs (e.g. anti-VEGF).
• •Known allergy or sensitivity to contrast agents used in imaging procedures.
• •Minimum LV wall thickness of less than 6mm as determined by ECHO.