Study to Evaluate the Safety and Efficacy of JVS-100 Administered to Adults With Ischemic Heart Failure.

Exclusion Criteria

• •Planned revascularization within 30 days following enrollment
• •Estimated Glomerular Filtration Rate \< 30 ml/min\*
• •Signs of acute heart failure within 24 hours of scheduled injection
• •History of aortic valve regurgitation classified as "moderate" or severe
• •Moderate/Severe aortic stenosis defined as AVA \<1.5 cm2
• •Note: Patient should not be excluded if the patient's medical records document that within the last 6 months the patient has either:
• •no aortic stenosis
• •mild aortic stenosis
• •normal aortic valve
• •normal aortic pressure gradient
• •aortic pressure gradient \< 20 mmHg
• •* Presence of an artificial aortic valve
• •* Subjects with aortic aneurysm \>3.8 cm
• •* Mitral regurgitation defined as "severe" measured by echocardiography at the clinical site.
• •* Patients with planned mitral valve repair or replacement surgery
• •* Any patient with a history of cancer will be excluded unless:
• •The cancer was limited to curable non-melanoma skin malignancies and/or
• •The cancer was removed by a successful tumor resection, with or without radiation or chemotherapy treatment, 5 years or more prior to enrollment in this study without recurrence
• •Subjects must have the following results on age appropriate cancer screenings:
• •Subjects age 50 or older have had a Fecal occult blood test (FOBT) or fecal immunochemical test (FIT) that was negative within the last year
• •Women age 30 or older have had a PAP test that was negative within the last 3 years
• •Women age 40 or older have had a mammogram that was negative within the last year
• •Men above age 45 have had a Prostate-Specific Antigen (PSA) blood test and digital rectal examination (DRE) that was negative within the last year
• •At the request of the site principal investigator, any subject with a non-negative result thought to be due to a non-cancer-related condition will be evaluated by the medical monitor for enrollment
• •Subjects with persistent or chronic atrial fibrillation will be excluded unless:
• •* A stable, regular heart rate is maintained with a biventricular pacemaker
• •* A stable, regular heart rate is maintained with a univentricular pacemaker pacing less than or equal to 40% of the time
• •Subjects with Biventricular pacing device implant within the last 3 months OR previously implanted Biventricular pacing device with programming planned to be reoptimized following enrollment in this trial
• •Previous solid organ transplant
• •Subjects with greater than 40% univentricular RV Pacing
• •Subjects with uncontrolled diabetes defined as HbA1c \>9.0%
• •Inability to complete 6 minute walk or treadmill exercise test
• •Participation in an experimental clinical trial within 30 days prior to enrollment
• •Any subject who has been enrolled in a gene or stem cell therapy cardiac trial within the last year
• •Life expectancy of less than 1 year
• •Positive pregnancy test (serum βHCG) in women of childbearing potential and/or unwillingness to use contraceptives or limit sexual activity as described in Section 8.2.1 below
• •Unwillingness of men capable of fathering a child to agree to use barrier contraception or limit sexual activity as described in Section 8.2.1 below
• •Subjects who are breast feeding
• •Subjects with a positive test results for hepatitis B/C and/or HIV
• •Total Serum Bilirubin \>4.0 mg/dl
• •Aspartate aminotransferase (AST) \> 120 IU/L
• •Alanine aminotransferase (ALT) \> 135 IU/L
• •Alkaline phosphatase (ALP) \>300 IU/L
• •Clinically significant elevations in PT or PTT relative to laboratory norms
• •Any subject with a known existing LV thrombus or has an LV thrombus detected during the screening period of this study.
• •Subjects with Rutherford class 5 or 6 critical limb ischemia
• •Subject with severe chronic obstructive pulmonary disease (COPD)
• •Any subject requiring home oxygen use
• •Subjects with a history of Systemic Lupus Erythematosus (SLE) flare
• •History of drug or alcohol abuse within the last year
• •A subject will be excluded if he/she is unfit for the trial based on the discretion of the site Principal Investigator