efficacy and safety of targeted intramyocardial delivery of auto cd34+ stem cells for improving exercise capacity in subjects with refractory angina

Conditions: Chronic Myocardial Ischemia; Refractory Angina Pectoris; Advanced Coronary Heart Disease

Summary: the purpose of the study is to assess the safety and efficacy of targeted intramyocardial delivery of auto-cd34+ cells for increasing exercise time and amelioration of anginal symptoms in subjects with refractory angina and chronic myocardial ischemia.


Eligibility criteria:
main inclusion criteria: * male or female participants who are 21 to 80 years of age at the time of signing the informed consent. * participants with canadian cardiovascular society (ccs) class iii or iv chronic refractory angina. * participants without control of their angina symptoms in spite of maximal tolerated doses of anti-angina drugs. participants must be on optimal therapy for their angina and must have been on a stable anti-anginal medication regimen for at least 4 weeks before signing the informed consent form. * participants with 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. * participants must have evidence of inducible myocardial ischemia. * participants must experience angina episodes. * participants must be able to complete 2 exercise tolerance tests on the treadmill within 3 weeks of randomization. * if female of childbearing potential, subject must not be pregnant and agree to employ adequate birth control measures for the duration of the study. main exclusion criteria: * cardiovascular hospitalization within 60 days prior to potential study enrollment. participant has had a successful or partially successful coronary artery bypass graft (cabg) within 6 months or pcta within 60 days of potential study enrollment. * participant has had a placement of a bi-ventricular pacemaker for cardiac resynchronization therapy (crt) for heart failure within 180 days of potential study enrollment. * participant has documented stroke or transient ischemic attacks (tias) within 60 days of potential study enrollment. * participant has a history of moderate to severe aortic stenosis; or severe aortic insufficiency; or severe mitral stenosis; or severe mitral insufficiency. * participant has a prosthetic aortic valve or a mechanical mitral valve replacement. * participant has severe co-morbidity associated with a reduction in life expectancy to less than 3 years as a result of chronic medical illnesses. * participants with cancer are excluded with the following exceptions: * subjects with in-situ non-melanoma skin cancer or in-situ cervical cancer are not excluded. * participants that have been cancer free for \>= 5 years as determined by their oncologist are not excluded. subjects with a prior history of stem cell transplant for cancer are excluded no matter how long they have been cancer-free. * participants with a history of leukemia or other bone marrow disease. * participant has sickle cell disease or sickle cell trait. * participants with proliferative retinopathy. * participants with hb a1c \> 9%. * participant has platelet counts \>10% above the upper limit of normal (uln) or platelet counts \< 70,000. * participant has a hematocrit \< 30% prior to potential study enrollment. * participant has a serum creatinine \> 2.5 mg/dl prior to potential study enrollment. * participant tests positive for hiv, hepatitis b, or hepatitis c, or is on chronic immunosuppressive medications, or has had a previous stem cell transplant. * participant has a known contraindication to neupogen (filgrastim) or g-csf. * participant 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 (lv) thickness of \< 7 mm in the target areas of injection as measured by during a 2-d echocardiogram (echo). * 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.