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