NAN-101 in Patients With Class III Heart Failure

- Age >18 years of age

- Chronic non-ischemic cardiomyopathy

- LVEF ≤ 30% by transthoracic echocardiography (TTE) within 6 months prior to enrollment

- NYHA Class III HF for a minimum of 6 months HF despite appropriate medical therapy (defined below):

- Females of childbearing potential must use at least one of the following acceptable birth control methods throughout the study and for 6 months after IP administration:

- Surgically sterile (bilateral tubal ligation, hysterectomy, bilateral oophorectomy) 6 months minimum prior to IP administration

- Intrauterine device in place for at least 90 days prior to receiving IP

- Barrier methods (diaphragm plus spermicide or condom) starting at least 30 days prior to receiving IP

- Abstinence (the subject must be willing to remain abstinent from screening to 6 months after receiving IP). Females are allowed to claim abstinence as their method of contraception only when it is the preferred and usual lifestyle of the subject

- Surgical sterilization of the partner(s) (vasectomy) for >180 days prior to IP administration

- Hormonal contraceptives starting > 90 days prior to IP. If hormonal contraceptives are started less than 90 days prior to receiving IP, subjects must agree to use a barrier method (diaphragm plus spermicide or condom) from screening through 90 days after initiation of hormonal contraceptives

- Males subjects capable of fathering a child:

- Must agree to use a condom from IP administration through 6 months after the time of IP administration

- Must agree not to donate sperm for 6 months after time of receiving IP

- Documented evidence of vasectomy in males for 180 days minimum prior to receiving IP is an acceptable form of contraception

- Males who claim abstinence as their method of contraception are allowed provided they agree to use barrier methods should they become sexually active from screening through 6 months after receiving IP. Males are allowed to claim abstinence as their method of contraception only when it is the preferred and usual lifestyle of the subject

- Ability to sign Informed Consent Form (ICF) and Release of Medical Information Form

- Appropriate candidate for protocol-specified intracoronary infusion in the judgment of the infusing interventional cardiologist

- Chronic ischemic cardiomyopathy

- Intravenous (IV) inotropic therapy, intra-aortic balloon pump (IABP) or percutaneous cardiac assist device therapy within 30 days prior to enrollment

- Restrictive cardiomyopathy, obstructive cardiomyopathy, pericardial disease, amyloidosis, infiltrative cardiomyopathy, uncorrected thyroid disease, or dyskinetic LV aneurysm

- Cardiac surgery or percutaneous coronary intervention (PCI) within 30 days prior to enrollment

- Third degree heart block

- Clinically significant myocardial infarction (MI) in the judgment of the subject's physician (e.g., ST elevation MI [STEMI] or large non-STEMI) within 6 months prior to enrollment

- Prior heart transplantation, left ventricular reduction surgery (LVRS), cardiomyoplasty, passive restraint device (e.g., CorCap™ Cardiac Support Device), surgically implanted LVAD or cardiac shunt

- Likely to receive cardiac resynchronization therapy, cardiomyoplasty, LV reduction surgery, heart transplant, conventional revascularization procedure, or valvular repair within 3 months of IP dosing

- Known hypersensitivity to contrast dyes used for angiography; history of, or likely need for, high-dose steroid pretreatment prior to contrast angiography

- Expected survival < 1 year in the judgment of the investigator

- Active or suspected infection within 48 hours prior to enrollment as evidenced by fever or positive culture

- Known intrinsic liver disease (e.g., cirrhosis, hepatitis A, chronic hepatitis B or hepatitis C virus infection). If serology is positive and PCR is negative, subject may be eligible (confirm with medical monitor).

- Liver function tests (alanine aminotransferase [ALT], aspartate aminotransferase [AST], alkaline phosphatase) > 2x upper limit of normal (ULN) within 30 days prior to enrollment.

- Renal Failure, dialysis dependent or serum creatinine > 2.5 mg/dl within 30 days prior to enrollment

- Bleeding diathesis or thrombocytopenia defined as platelets <50,000 platelets/μL within 30 days prior to enrollment

- Anemia defined as hemoglobin <10 g/dL or transfusion dependent within 30 days prior to enrollment

- Neutropenia defined as absolute neutrophils <1500 mm3 within 30 days prior to enrollment

- Known AIDS or HIV-positive status, or a previous diagnosis of immunodeficiency with an absolute neutrophil count <1000 cells/mm3

- Previous participation in a study of gene transfer

- Receiving investigational intervention or participating in another clinical study within 30 days or within 5 half-lives of another investigational drug administration prior to administration of NAN-101 that may impact the therapeutic potential of NAN-101.

- Pregnancy or breastfeeding at the time of screening