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

Inclusion Criteria:

Diagnosis of ischemic or nonischemic DCM according to World Health Organization criteria; OR ischemic DCM (DCM in a patient with a history of myocardial infarction or evidence of clinically significant (>/= 70% narrowing of a major epicardial artery) coronary artery disease)
No other cardiac surgery or percutaneous cardiac interventions likely to produce clinical improvement, in the opinion of the investigator and the referring interventional cardiologist
Left ventricular ejection fraction Symptomatic heart failure in NYHA functional class III or IV
Able to comply with scheduled visits in cardiac out-patient clinic
Able to tolerate study procedures, including bone marrow aspiration, left lateral thoracotomy or thoracoscopy with single lung ventilation, MRI or cardiac CT, spirometry and 6 minute walk test
Males and females, 18-86 years of age
Life expectancy of 6 months or more in the opinion of investigator
Able to give informed consent
Normal organ and marrow function (Leukocytes >/= 3,000/microgram, Absolute neutrophil count >/= 1,500/microgram, Platelets >/= 140,000/microgram, AST (SGOT)/ALT (SGPT) Adequate pulmonary function (forced expiratory volume in one second [FEV1] > 50% predicted)
Controlled blood pressure (systolic blood pressure Adequate medical management of DCM and other pre-existing conditions. Drug treatment regimen must have been established for at least a month prior to randomization in eligible patients.
Fertile patients must agree to use an appropriate form of contraception while participating in the study

Exclusion Criteria:

Severe primary valvular insufficiency(ies)
Known history of Chronic Obtrusive Pulmonary Disease (Gold stages IIB or more severe only) or restrictive pulmonary disease
Known history of primary pulmonary hypertension
Ventricular Assist Device implantation
Myocardial infarction within 4 weeks of randomization
Life-threatening ventricular arrhythmia, except if implantable cardioverter defibrillator is implanted
Unstable angina, characterized by increasingly frequent episodes with modest exertion or at rest, worsening severity, and prolonged duration
Patients receiving treatment with hematopoietic growth factors
Patients who require uninterruptible anticoagulation or anti-platelet therapy [i.e. anticoagulation therapy (e.g. warfarin) that cannot be stopped for 72 hours prior to bone marrow aspiration and intramyocardial injections]
Patients receiving anti-platelet therapy (e.g. clopidogrel) that cannot be stopped for 7 days prior to bone marrow aspiration and intramyocardial injections
Known cancer and undergoing treatment including chemotherapy and radiotherapy
Patients who will require continuous, systemic, high dose corticosteroid therapy (more than 7.5 mg/day) within 6 months after surgery
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 within 6 months of screening
Known allergies to protein products (horse or bovine serum, or porcine trypsin)
Body Mass Index 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 time of screening
In the opinion of the investigator, patient is unsuitable for cellular therapy
Patients receiving anti-angiogenic drugs