study to evaluate the safety and efficacy of jvs-100 administered to adults with ischemic heart failure.

Conditions: Ischemic Heart Failure

Summary: this is a randomized, double-blind, placebo controlled phase ii study is designed to assess the safety and efficacy of using jvs-100 to treat heart failure.

90 subjects with ischemic cardiomyopathy will be randomized to receive a single dose of 15 or 30 mg of jvs-100 or matching placebo. subjects will be randomized 1:1:1 to receive either placebo, 15 mg or 30 mg of jvs-100. subjects will be monitored overnight for 18-24 hours post dose and have scheduled visits at 3 days post-injection for safety evaluations. all subjects will be scheduled for follow-up visits at approximately 30 days (1 month), 120 days (4 months), and 360 days (12 months) to assess safety and cardiac function.

Eligibility criteria:
inclusion criteria: * willing and able to sign informed consent * greater than or equal to 18 years of age * subjects with impaired 6 minute hall walk distance * impaired quality of life as measured by minnesota lwhf questionnaire * ischemic cardiomyopathy without an acute coronary syndrome within the last 6 months * residual well-demarcated region of lv systolic dysfunction defined as at least 3 consecutive segments of abnormal wall motion by echocardiography read at the echocardiography core laboratory * lvef ≤40% measured by echocardiography read at the echocardiography core laboratory * must meet wall thickness criteria * subject has an implanted, functional aicd * subjects with diabetes must have had an ophthalmologist exam within the last year showing no active proliferative retinopathy * subject receiving stable optimal pharmacological therapy defined as: * ace inhibitor and/or arb, and beta-blocker for 90 days with stable dose for 30 days unless contraindicated * diuretic in subjects with evidence of fluid retention * asa unless contraindicated * statin unless contraindicated * aldosterone antagonist per physician discretion 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 exclusion criteria (ctd): * 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