ACT34-CMI -- Adult Autologous CD34+ Cells

Exclusion Criteria

• •predominant congestive heart failure
• •myocardial infarction within 60 days of treatment
• •successful or partially successful coronary revascularization procedures (any vessel) within 6 months of study enrollment
• •placement of a bi-ventricular pacemaker for cardiac resynchronization therapy (CRT) for heart failure in the past 90 days
• •documented stroke or transient ischemic attack (TIA) within 60 days of study enrollment
• •history of moderate to severe aortic stenosis or severe aortic insufficiency; severe mitral stenosis or severe mitral insufficiency
• •prosthetic aortic valve replacement
• •evidence of any life-threatening arrhythmia that requires intervention on the 24-hour Holter monitor. Life-threatening arrhythmia that is successfully treated with an implantable cardioverter defibrillator (ICD) is not exclusionary.
• •splenomegaly and/or severe co-morbidity associated with a reduction in life expectancy of less than 1 year, such as chronic medical illness (ie, severe chronic obstructive pulmonary disease, renal failure or cancer \[exceptions: in-situ skin cancer or fully removed skin cancer other than melanoma, in-situ cervical cancer, or cancer free for 5 years with no history of a stem cell transplant\])
• •sickle cell disease or sickle cell trait
• •platelet count greater than 10% above the upper limit of normal or a platelet count below 100,000 if on Clopidogrel or 50,000 without Clopidogrel
• •hematocrit \<30%
• •serum creatinine \>2.5 mg/dL
• •any clinically significant laboratory abnormality on screening laboratories
• •currently enrolled in another IDE or IND that has not completed the protocol required primary follow-up period (excludes 15 year follow up of gene therapy trials)
• •history of alcohol or drug abuse within 3 months of screening
• •joint or peripheral vascular disease or neurologic disease that severely limits treadmill walking
• •chronic obstructive pulmonary disease that severely limits walking or FEV1 \<30% predicted
• •females who are pregnant or lactating
• •female subjects who are capable of reproduction and will not use medically valid contraception to prevent pregnancy during the study
• •subjects who test positive for HIV, hepatitis B or hepatitis C, or are on chronic immunosuppressive medications or have had a prior stem cell transplant
• •subjects with a known hypersensitivity to E. coli-derived proteins, or to any component of Neupogen (Filgrastim) or G-CSF
• •subjects who have a significant psychiatric disorder or mental disability that could interfere with the subject´s ability to provide informed consent and/or comply with protocol procedures