This research study is being performed to find out more information about the safety and effectiveness of injecting Bone Marrow (from your own hip bone) progenitor cells (BMPCs) into your heart muscle. The BMPCs are the cells from which the different types of blood and other cells grow.

In patients with heart failure, the heart muscle does not pump well. Over a period of years, this continues to get worse until the patient dies of heart failure. We are trying to find out if the injection of these BMPCs can make a change in the functioning of these areas of the heart muscle. Data from studies around the world have suggested that when patients with heart failure receive these cells by direct injection into their hearts they show signs of recovered heart function, however, there has been no evidence from actual studies of the cells of the patient’s hearts to show how this process works. It is our plan to inject your heart with cells that are from your own bone marrow during your operation to receive a ventricular assist device (VAD) or partial artificial heart and then to study the function of your heart while you await a heart transplant. We will then examine your heart after it has been removed as part of your regular heart transplant operation for any microscopic changes (changes too small to be seen by the unaided eye but large enough to be studied under a microscope) at the site where the cells are injected. You will have no change in your chances of receiving a heart transplant by agreeing to participate in this study. You will also have no delay in receiving a VAD operation while waiting to participate in this study. This study has been cleared by the Food and Drug Administration (FDA) – Phase I to enroll and treat patients. IND BB #12304. (Phase I trial is a research study using techniques or products in the first-stage or for the first time in human subjects).

Inclusion Criteria:

• Age >=18 years.
• Congestive heart failure with ejection fraction  35.
• Candidates for ventricular device placement as a bridge to transplant.
• Serum bilirubin, SGOT and SGPT 2.5 time the upper level of normal.
• Serum creatinine < 2.0 times normal or no dialysis.
• NYHA performance status > 3.
• Negative pregnancy test (in women with childbearing potential).

Exclusion Criteria:

• Pregnant or breastfeeding women.
• History of Prior Radiation Exposure.
• History of Bone Marrow Disorder.
• History of abnormal Bleeding or Clotting.
• History of Liver Cirrhosis.
• Inability to obtain 1 x 106 CD 34+ cells after bone marrow processing.
• Acute Myocardial Infarction < 6 days from acute event.
• Prior malignancy in the 5 years before treatment in this study (other than curatively treated carcinoma in-situ of the cervix or non-melanoma skin cancer).
• Inability or unwillingness to comply with the treatment protocol, follow-up, research tests, or give consent.
• Eligible for destination ventricular assist device placement.
• Unable to have 250cc bone marrow harvested.