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.