Feasibility Study of BMAC Enhanced CABG

Patients undergoing CABG will have 60 mL of bone marrow drawn, concentrated in a SmartPRep2
centrifuge and have the concentrated nucleated cells injected into areas of ischemic
myocardium. Control subjects will undergo CABG only

Inclusion Criteria:

- Age> 18 years and ability to understand the planned treatment.

- Patients with ischemic congestive heart failure requiring by pass surgery

- Congestive heart failure with ejection fraction ≤ 40%.

- Serum bilirubin, SGOT and SGPT ≤2.5 time the upper level of normal.

- Serum creatinine < 3.0 or no dialysis.

- NYHA performance status ≥ 3.

- Negative pregnancy test (in women with childbearing potential).

- Subject has read and signed the IRB approved Informed Consent form

- Hematocrit ≥ 28.0%, White Blood Cell count ≤ 14,000, Platelet count ≥ 50,000,
Creatinine ≤ 3.0 mg / Dl, and/or no dialysis, INR ≤ 1.6 unless on Coumadin, or PTT
<1.5 x control (to avoid bleeding complications) Patients on Coumadin will be
corrected prior to the procedure and must have an INR<1.6 at the time of
randomization/surgery

Exclusion Criteria:

- Female who is pregnant or nursing, or of child bearing potential and is not using a
reliable birth control method, or who intend to become pregnant during the tenure of
this study.

- History of Prior Radiation Exposure for oncological treatment.

- History of Bone Marrow Disorder (especially NHL, MDS) that prohibit transplantation.

- History of abnormal Bleeding or Clotting.

- History of Liver Cirrhosis.

- Acute Myocardial Infarction < 4 weeks from treatment date.

- Known active malignancy or results outside of normal limits from the following tests:
PAP, Chest X-ray, PSA, Mammogram, Hemoccult unless follow-up studies reveal patient
to be cancer free.

- Active clinical infection being treated by antibiotics within one week of enrollment

- Terminal renal failure with existing dependence on dialysis

- Inability or unwillingness to comply with the treatment protocol, follow-up, research
tests, or give consent.

- Unable to have 250cc bone marrow harvested.

- Medical risk that precludes anesthesia or ASA Class 5

- History of ventricular arrhythmia if AICD is not present.

- History of ventricular aneurysm.

- Concurrent surgery such as CABG with valve surgery.

- Minimally Invasive bypass surgery

- Life expectancy <6 months due to concomitant illnesses

- Treatment with immunosuppressant drugs (including Prednisone > 5 mg per day)

- Patients undergoing urgent by pass surgical procedure

- Patients with HGB A1C > 8.5%