BMAC Enhanced Coronary Artery Bypass Grafting (CABG)

Harvest Technologies

Status and phase

Terminated

Phase 2

Phase 1

Conditions

Congestive Heart Failure

Treatments

Device: Harvest SmartPReP2 BMAC System

Study type

Interventional

Funder types

Industry

Identifiers

2009-1

Details and patient eligibility

About

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

Full description

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

Enrollment

20 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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%