The purpose of this study is to determine the safety and effectiveness of intracoronary infusion of autologous cardiac stem cells in patients with ischemic cardiomyopathy.

This phase I trial will involve 6 patients suffering from chronic ischemic cardiomyopathy and congestive heart failure, to be compared with historical control subjects. This study will be conducted as a collaborative project between the Sakakibara Heart Institute and the CellBank of Japan. The trial is designed to assess the safety and effectiveness of autologous administration of 1,000,000 c-kit-positive cardiac stem cells (CSCs) via intracoronary route following cultivation. The preliminary eligibility criteria will utilize a left ventricular ejection fraction (LVEF) less than 40% measured by echocardiography. During the coronary artery bypass grafting (CABG) surgery, a part (less than 1 gram) of the right atrial appendage (RAA) will be harvested and frozen. When the LVEF is less than 40% after the CABG surgery, the subject will be enrolled as a candidate for the delivery of CSCs, which will be selected from the RAA tissue and cultured for a few months for expansion. The outcome will be evaluated by adverse events as well as cardiac functions.

Inclusion Criteria:

• Adult with ability to provide informed consent.
• Left ventricular ejection fraction less than 40% as evidenced by echocardiogram.
• Scheduled for elective surgical revascularization within 2 months.

Exclusion Criteria:

• Positive for HBs-Ag, HCV-Ab, HIV-Ab, or tests for syphilis.
• Diabetic HbA1c greater than 8.5%.
• Pregnant women.
• Scheduled for additional interventions including ventriculoplasty.