Angiogenesis: CD34+ Phase II

Study of:

CD34+ Phase II: A double-blind, prospective, randomized, placebo controlled study to determine the tolerability, efficacy, safety, and dose range of intramyocardial injections of autologous CD34+ cells for reduction of angina episodes in patients with refractory chronic myocardial ischemia.

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 three 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 at weeks 1 and 4, months 3, 6, and 12 after the procedure. Many clinical sites will enroll 150 patients into this clinical trial.

Timothy D. Henry, MD, FACC

Randall K. Johnson, MD, FACC

Anil K. Poulose, MD, FACC

Jay H. Traverse, MD, FACC, FAHA

Terri Arndt, RN, MA, CCRC

Karen L. Harvey, RN

Rachel Olson, RN, MS, CCRC

Dodie Walton, RN, 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.