Angiogenesis in Women With Angina Pectoris Who Are Not Candidates for Revascularization

Inclusion Criteria:

• Female patients 18-75 years of age inclusive

• Stable angina classified as CCS III or IV

• Receiving treatment with at least two classes of chronic anti-anginal medication, ofwhich two are at the maximally tolerated dose

• Left ventricular ejection fraction (LVEF) of ≥30%

• Not a candidate for, or unlikely to benefit from standard revascularization proceduresas verified by an independent cardiologist or cardiothoracic surgeon (not a studyinvestigator) at each center

• Can undergo ETT using the modified Bruce protocol and;

1. ECG changes diagnostic of myocardial ischemia occur during the first 10 minutesof exercise

2. Variability of the time to onset of ECG changes diagnostic of myocardial ischemiais ≤25% or within 60 seconds if the time to onset of myocardial ischemia occurswithin the first 4 minutes of exercise as determined by two consecutive screeningtreadmill tests

• Evidence of stress induced myocardial ischemia by adenosine SPECT, defined as areversible perfusion defect size of ≥9%

• Willing and able to comply with the study requirements including long-term follow-up

• Provided written informed consent

Exclusion Criteria:

• Patients of childbearing potential (must be surgically sterile or post-menopausal)

• Patients for whom an immediate revascularization procedure is indicated (CABG surgeryor PCI)

• Myocardial infarction within the past 3 months

• Unstable angina or hospitalization requiring intravenous anti-anginal therapy withinthe 14 days prior to the start of screening evaluations

• Congestive heart failure NYHA Class IV

• Electrocardiogram that precludes accurate assessment of exercise induced myocardialischemia (e.g., left bundle branch block, Wolf-Parkinson-White syndrome, atrialfibrillation)

• Myocarditis or restrictive pericarditis

• Left main coronary stenosis ≥70% (unless the patient has a patent graft or collateralvessels supplying the left coronary circulation) or proximal stenoses ≥70% in allmajor coronary conduit vessels (coronary arteries and bypass grafts)

• Clinically significant aortic or mitral valvular heart disease

• Coronary ostial stenosis that precludes adequate catheter engagement in any targetvessel

• Coronary artery to venous communications, which bypass the coronary capillary bed

• Untreated life-threatening ventricular arrhythmias

• CABG surgery within the past 6 months, unless those grafts are now occluded.

• Percutaneous transluminal angioplasty (PTCA) within the past 3 months, unless thedilated vessel(s) are now occluded

• Enhanced external counterpulsation (EECP) within 3 months prior to the start ofscreening evaluations

• Transmyocardial or percutaneous myocardial laser revascularization within the previousyear

• Prior treatment with any cardiovascular gene or stem cell therapy.

• Any intercurrent illness that may interfere with their ability to perform a maximalETT

• Any major organ disease that substantially impairs life expectancy.

• History of cancer, other than basal cell carcinoma, or patients with any laboratory orphysical exam or diagnostic procedure finding suggestive of current malignancy

• Moderate to severe nonproliferative or proliferative retinopathy from any cause (ETDRSscore >35), clinically significant macular edema, or previous panretinalphotocoagulation therapy

• Heparin induced thrombocytopenia or history of idiopathic thrombocytopenic purpura orother medical condition causing thrombocytopenia

• SGPT level greater than 2.0 times the upper limit of the laboratory normal range

• Bilirubin level ≥2.0 mg/dL

• Serum creatinine ≥2.5 mg/dL

• Platelet count <100,000/μL

• White blood cell count <3,000/μL

• Positive test for hepatitis B or C

• Positive test for HIV

• History of colon cancer in a first degree relative (i.e., parent, sibling oroffspring) unless the patient has undergone a colonoscopy in the past 36 months withnegative findings

• History of breast cancer in a first degree relative

• Patient in a family with any documented hereditary cancer syndrome

• Prior anaphylaxis reaction to iodinated contrast agents

• Patients who are known to be immunosuppressed or are receiving chronic treatment withimmunosuppressive drugs

• Received an investigational drug or biologic within 30 days of screening or arecurrently participating in an investigational drug, biologic or device trial