This research study is being performed to find out more information about the safety of injecting Bone Marrow (from your own hip bone) progenitor cells (BMPCs) into your heart muscle. The study may also determine the optimal dose of BMPCs for congestive heart failure. 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 either plain serum (the liquid part of your blood that does not contain any blood cells) or cells from your own bone marrow (BMPCs) into your heart during your Coronary Artery Bypass Grafting operation (CABG) and then to study the function of your heart. We are trying to find out if the injection of these BMPCs into the damaged areas of the heart muscle can improve the functioning of these areas. The Food and Drug Administration (FDA) has approved enrollment of patients into Phase I of this study (A Phase I trial is a research study using techniques, or products for the first time in human subjects).

Condition	Intervention	Phase
Heart Failure	Drug: Injection of Bone Marrow Progenitor Cells into the Heart	Phase I

Further Study Details: 

Primary Outcomes: Heart Function change 6 month post-implant.
Secondary Outcomes: Toxicity; Optimal dose of BMPCs
Expected Total Enrollment:  75

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• Age >=18 years.
• Patients with ischemic congestive heart failure undergoing primary isolated CABG.
• Congestive heart failure with ejection fraction <=40.
• 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:

• Prior cardiac surgery.
• 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.
• Unable to have 250cc bone marrow harvested.
• History of ventricular arrhythmia if AICD is not present.
• History of ventricular aneurysm.
• Concurrent surgery such as CABG with valve surgery
• Pregnant or breastfeeding women.

Please refer to this study by ClinicalTrials.gov identifier  NCT00130377

Amit N. Patel, MD, MS      412-648-6259    patelan@upmc.edu
Joyce A. Szczepanski, BS, MBA      412-648-6307    szczepanskija2@upmc.edu

Pennsylvania
      University of Pittsburgh Medical Center, Pittsburgh,  Pennsylvania,  15213,  United States; Recruiting

Study chairs or principal investigators

Amit N. Patel, MD, MS,  Principal Investigator,  University of Pittsburgh   

Study ID Numbers:  0506137
Last Updated:  August 12, 2005
Record first received:  August 12, 2005
ClinicalTrials.gov Identifier:  NCT00130377
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-08-23