Clinical Drug Experience Knowledgebase

Criteria

Inclusion Criteria:

Aged 30-75 years, male or female, with coronary artery disease
Patients over 50 years of age agree to undergo sigmoidoscopy, unless they have undergone such an exam or colonoscopy within the preceding 36 months with negative findings
CCS angina Class 2 to 4
Stable angina for =>4 weeks despite antianginal drug treatment, and who are able to exercise for at least 3 minutes but no more than 10 minutes on the first qualifying baseline ETT and no more than 12 minutes on the last qualifying baseline ETT using the modified Balke exercise protocol
LVEF =>30% by echocardiography, LV angiogram, or a MUGA scan undertaken within the preceding 12 months
Classic angina or angina equivalent associated with =>1mm ST segment depression (horizontal or down sloping) at least in the first qualifying ETT. The variability in exercise duration (time to grade 3/4 angina or angina equivalent) does not vary by > 20% in 2 consecutive tests
Single, double, or triple vessel coronary artery disease. Patients with 3 vessel disease should have at least 1 proximal major vessel or graft with <70% stenosis
Patients who do not require immediate PTCA or CABG surgery
Provided written informed consent

Exclusion Criteria:

Unstable angina
CCS Class 1 angina
Patients in whom ECG evidence of exercise induced myocardial ischemia is difficult to detect
Intercurrent illness which may interfere with the ability to perform the ETT
Untreated life-threatening ventricular arrhythmias
Left main coronary artery stenosis =>70%, unless bypassed with a patent graft
Coronary artery bypass surgery within the past 6 months, unless those grafts are closed
In situ arterial CABG other than the RIMA or LIMA, unless it is 100% occluded
Myocardial infarction within the last 8 weeks
CHF (NYHA class IV) despite treatment
Angioplasty within the previous 6 months
Prior transmyocardial laser revascularization
Enhanced external counterpulsation (EECP) within 12 weeks prior to study entry
Coronary ostial stenosis that precludes adequate catheter engagement in any target vessel
Coronary artery to venous communications which bypass the coronary capillary bed
Heparin associated thrombocytopenia (HIT)
Moderate to severe nonproliferative or proliferative retinopathy from any cause (ETDRS Score > 35), clinically significant macular edema, or previous panretinal photocoagulation therapy
History of malignant neoplasms (except superficial basal cell skin carcinoma) within the past 10 years
Malignant tumors or abnormal cancer screening tests suspicious for cancer, or patients in whom screening exams indicate possible occult malignancy, unless malignancy has been ruled out
Family history of colon cancer in any first-degree relative, unless the patient has undergone a colonoscopy within the past 12 months with negative findings
Elevated PSA level (unless prostate cancer has been excluded)
HIV positive
Hepatic disease or those who are positive for hepatitis B or C, or whose SGPT is > 2 times the upper limit of normal range, or whose serum bilirubin is > 2 mg/dL.
Proteinuria => 2+ unless all other renal parameters are within normal limits.
Creatinine clearance < 45 ml/min
Platelet count less than 130 x 10(3)/microL
WBC count less than 3.0 x 10(3)/microL
Patients who are known to be immunosuppressed and/or are receiving chronic immunosuppressive therapy
Female patients of childbearing potential. Male patients who do not agree to use birth control (condom) for a period of 8 weeks following study product administration
Investigational drug therapy within 30 days of treatment
Patients who have received any gene therapy product or angiogenic growth factor protein product
Underlying disease(s) other than CAD resulting in a life expectancy of less than 1 year
Any clinical abnormality or social circumstance that puts successful completion of the trial in doubt