Angiogenesis: CD34+ for Low Ejection Fraction: Injection of Autologous CD34-Positive Cells for Neovascularization and Symptom Relief in Patients with Myocardial Ischemia and LVEF <40%

Study of:

The purpose of this study is to determine the safety of various doses of one’s own stem cells, delivered with a catheter (tube) into the regions of the heart with poor blood flow. Stem cells are simple cells produced by bone marrow that can develop into blood cells or other types of cells. It is possible that these cells will grow into very small blood vessels that may bring blood to the heart which may relieve chest pain. The CD34-Positive Cells will be taken from the body during a 4-5 hour process called apheresis. Apheresis is similar to donating blood, however, only the part of the blood that is needed, white blood cells, is removed and the rest of your blood is returned to your body.

The CD34-Positive Cells will be delivered into your heart muscle during a cardiac catheterization. Patients will be required to follow up for clinic visits 1 week, 1, 3, 6, and 12 months after the procedure. Two clinical sites will enroll 24 patients into this clinical trial. This study does include a placebo group that has the option to cross-over to the treatment group at 6 months post catheterization procedure if entry criteria is met.

Timothy D. Henry, MD, FACC

Randall K. Johnson, MD, FACC

Anil K. Poulose, MD, FACC

Jay H. Traverse, MD, FACC, FAHA

Karen L. Harvey, RN

Patti Mitchell, RN, BSN

Rachel Olson, RN, MS, CCRC

For more information about this study or the Angiogenesis Research program at the Minneapolis Heart Institute Foundation, please call Anne Nelson at 612-863-6121.