University of Florida doctors last week have treated their first patient enrolled in a new study designed to test whether injecting stem cells into the heart helps restore blood flow to the organ by prompting new blood vessels to grow.
UF researchers plan to test the experimental therapy in people with severe coronary artery disease and daily chest pain who have not responded to traditional medications or surgical procedures designed to restore blood flow, such as angioplasty or bypass surgery.
“The general idea is that by providing these cells of blood vessel origin, we hope to either generate new blood vessels from the growth of these implanted cells or stimulate the heart to regenerate new blood vessels from the cells that reside in it,” said study investigator Dr. Carl J. Pepine, chief of cardiovascular medicine at UF’s College of Medicine.
“It’s not completely clear whether it’s the actual cell itself that would do this or whether it’s just the milieu and the chemical signals that occur from the cells that would result in this.”
UF is one of 20 research sites participating in the national study, which is evaluating a total of 150 patients and is sponsored by the Cellular Therapies business unit of Baxter Healthcare Corp. and led by principal investigator Dr. Douglas Losordo, of Northwestern University’s Feinberg School of Medicine. Baxter makes the cell-sorting equipment used to isolate the cells from the blood.
Pending Food and Drug Administration approval, UF researchers, through the National Heart, Lung and Blood Institute-funded Cardiovascular Cell Therapy Research Network, are gearing up to launch three other multicenter studies within the next several months that use other types of a patient’s own stem cells.
One trial focuses on patients who have had a heart attack within a week preceding study enrollment, another focuses on patients whose heart attack occurred within the preceding two to three weeks, and the third focuses on patients with congestive heart failure or chronic chest pain that has not responded to traditional treatment.
These studies will use stem cells taken directly from the patients’ bone marrow instead of stem cells isolated from the bloodstream, Pepine said, and will test whether various cell therapies can improve the heart’s plumbing by helping to repair blood vessels or form new ones and strengthen the heart muscle to improve its ability to pump efficiently.
Dr. Douglas E. Vaughan, chief of the division of cardiovascular medicine at Vanderbilt University Medical Center, said the study is important and targets a challenging group of patients who need new options.