Ensayos clínicos

Inclusion Criteria

• Male or female
• Age 21 to 80 years at the time of signing the informed consent
• Canadian Cardiovascular Society (CCS) class III or IV chronic refractory angina
• Without control of angina symptoms in spite of maximal tolerated doses of anti-angina drugs
  • Must be on optimal therapy for angina and must have been on a stable anti-anginal medication regimen for at least 4 weeks before signing the informed consent form
• Has obstructive coronary disease unsuitable for conventional revascularization due to unsuitable anatomy or comorbidity as determined at the site and confirmed by an independent adjudication committee
• Must have evidence of inducible myocardial ischemia
• Must experience angina episodes
• Must be able to complete 2 exercise tolerance tests on the treadmill within 3 weeks of randomization
• If female of childbearing potential, must not be pregnant and agrees to employ adequate birth control measures for the duration of the study

Exclusion Criteria

• Cardiovascular hospitalization within 60 days prior to potential study enrollment
• Has had a successful or partially successful coronary artery bypass graft (CABG) within 6 months or PCTA within 60 days of potential study enrollment
• Has had a placement of a bi-ventricular pacemaker for cardiac resynchronization therapy (CRT) for heart failure within 180 days of potential study enrollment
• Has documented stroke or transient ischemic attacks (TIAs) within 60 days of potential study enrollment
• Has a history of moderate to severe aortic stenosis,  severe aortic insufficiency, severe mitral stenosis, severe mitral insufficiency
• Has a prosthetic aortic valve or a mechanical mitral valve replacement
• Has severe co-morbidity associated with a reduction in life expectancy to less than 3 years as a result of chronic medical illnesses
• Cancer, with the following exceptions
  • In-situ non-melanoma skin cancer or in-situ cervical cancer
  • Has been cancer free for ≥ 5 years as determined by oncologist
• Prior history of stem cell transplant for cancer, no matter how long they have been cancer-free
• History of leukemia or other bone marrow disease
• Has sickle cell disease or sickle cell trait
• Proliferative retinopathy
• Hb A1c > 9%
• Has platelet counts >10% above the upper limit of normal (ULN) or platelet counts < 70,000
• Has a hematocrit < 30% prior to potential study enrollment
• Has a serum creatinine > 2.5 mg/dL prior to potential study enrollment
• Tests positive for HIV, hepatitis B, or hepatitis C, or is on chronic immunosuppressive medications, or has had a previous stem cell transplant
• Has a known contraindication to Neupogen (filgrastim) or G-CSF
• Was previously enrolled in an active treatment group of cell therapy trials for cardiovascular disease including any phase of CD34+ stem cell trials
• Left ventricular thickness of < 7 mm in the target areas of injection as measured during a 2-D echocardiogram
• Atrial fibrillation, atrial flutter, or other uncontrolled arrhythmias that would prohibit accurate electromechanical mapping and NOGA-guided intramyocardial injection
• Bleeding diathesis with an INR > 1.8 when not receiving anti-thrombotic therapy
• Hepatic dysfunction as evidenced by elevated AST or ALT levels > 2.5 x ULN
• Any previous transplant requiring immunosuppression
• Disease state requiring chronic immunosuppression