CardiAMP Cell Therapy Chronic Myocardial Ischemia Trial

Randomized Controlled Pivotal Trial of Autologous Bone Marrow Cells Using the CardiAMP Cell Therapy System in Patients With Refractory Angina Pectoris and Chronic Myocardial Ischemia (CardiAMP CMI Trial)

Prospective, multi-center, 2:1 randomized (Treatment : Sham Control), sham-controlled, double-blinded trial to compare treatment using the CardiAMP cell therapy system to sham treatment

Treatment Group:

Subjects treated with aBMC using the CardiAMP cell therapy system

Sham Control Group:

Subjects treated with a Sham Treatment (no introduction of the Helix transendocardial delivery catheter, no administration of aBMC)

Inclusion Criteria:

1. Male or female 21 to 80 years of age
2. Canadian Cardiovascular Society (CCS) class III or IV chronic refractory angina.
3. Lack of control of angina symptoms despite maximum tolerated doses of anti-angina drugs.
4. Evidence of inducible myocardial ischemia on baseline stress testing
5. Obstructive coronary disease unsuitable for conventional revascularization
6. Experience angina episodes at a minimum of 7 angina episodes per week (during a 4-week screening period).
7. Able to complete an exercise tolerance test on the treadmill
8. Left ventricular ejection fraction of greater than or equal to 40% as measured by echocardiography.
9. Qualification of a pre-procedure screening of bone-marrow aspiration

Exclusion Criteria

Other cardiac or vascular system or other health-related criteria which may be seen in a patient's history and physical examination.