Feasibility Study of BMAC Enhanced CABG

Study Overview
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Brief Summary
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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

Detailed Description
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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

Official Title
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Feasibility Study of Autologous Concentrated Bone Marrow Nucleated Cell Therapy for Congestive Heart Failure Patients Undergoing Treatment With Coronary Artery Bypass Grafting(CABG) Surgery

Conditions
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Congestive Heart Failure

Intervention / Treatment
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* Biological: BMAC
* Procedure: CABG only


Participation Criteria
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Eligibility Criteria
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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%

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control<br>CABG only | Procedure: CABG only<br>* Control subjects will undergo CABG surgery without BMAC injection<br>|
| Experimental: BMAC enhanced CABG<br>Injection of concentrated bone marrow nucleated cells (BMAC) as an adjunct to CABG surgery | Biological: BMAC<br>* Injection of BMAC into ischemic myocardium during CABG<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Cardiac Status (Classification) | A change in cardiac status as determined by the New York Heart Association (NYHA) or Canadian Cardiovascular Society (CCS) classification evaluation | Through 12 months post treatment | 
| Safety | as measured by frequency and severity of adverse events | through 1 Year post tx |