Injection of concentrated bone marrow cells into the myocardium during CABG procedure.
Who can participate
Age range18 Years
SexALL
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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 …