BMAC Enhanced Coronary Artery Bypass Grafting (CABG)

Study Overview
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Brief Summary
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Injection of concentrated bone marrow cells into the myocardium during CABG procedure.

Detailed Description
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Injection of autologous concentrated bone marrow cells into the myocardium during CABG procedure.

Official Title
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Dose Response 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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* Device: Harvest SmartPReP2 BMAC System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects must meet all of the following inclusion criteria to be enrolled in the trial: 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: Subjects will be excluded if they meet any of the 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, Hemocult 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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CABG plus BMAC Injection<br>Injection of Bone Marrow Aspirate Concentrate (BMAC) into ischemic myocardium following CABG during the same open procedure | Device: Harvest SmartPReP2 BMAC System<br>* Injection of 10, 15, or 20 cc of BMAC<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in left ventricular function |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| QOL (Rand 36; Minnesota Living with Heart Failure Questionnaire) |  | 12 months | 
| NYHA or CCS classification evaluation |  | 12 months | 
| Changes in left ventricular ejection fraction |  | 12 months | 
| Changes in left ventricular end-diastolic volume |  | 12 months | 
| Safety |  | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bone Marrow Concentrate, CABG, Cardiac, Stem Cell