Efficacy and Safety of Targeted Intramyocardial Delivery of Auto CD34+ Stem Cells for Improving Exercise Capacity in Subjects With Refractory Angina

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.