University of Florida (UF) doctors have treated their first patient enrolled in a new study designed to test whether injecting stem cells into the heart helps to restore blood flow to the organ by prompting new blood vessels to grow.
UF researchers are testing the experimental therapy in patients with severe coronary artery disease and daily chest pain, who are not responding to traditional medications or surgical procedures designed to restore blood flow, such as angioplasty.
“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 Carl Pepine, MD, 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.”
In the prospective, double-blind, placebo-controlled study, known as the Autologous Cellular Therapy CD34-Chronic Myocardial Ischemia Trial, UF researchers will study 15 Shands at UF Medical Center patients to determine whether a person’s own stem cells can be used to effectively and safely treat chronic reductions in blood flow to the heart, improving symptoms and long-term outcomes.
After undergoing screening tests, the participants will receive a series of protein injections that release stem cells from the bone marrow into the bloodstream. Participants will then be randomly assigned to receive one of two dosing levels of the cells, or a placebo.
“Physicians will use a catheter-based electrical mapping system to find muscle they think is still viable but not functioning,” noted R. David Anderson, an associate professor of medicine at UF and director of interventional cardiology. “The cells are injected into viable sites in the heart, which have poor blood flow, in the cardiac catheterization laboratory at Shands at UF Medical Center.”
Patients will be periodically evaluated by echocardiography and MRI over the course of a year after the procedure. To date participants have tolerated the procedure well, though potential risks include infection, allergic reactions, bleeding, blood clots and damage to the heart or its vessels.
UF is one of 20 research sites participating in the national study, evaluating a total of 150 patients and is sponsored by the Cellular Therapies business unit of Baxter Healthcare.
Pending the U.S. FDA approval, UF researchers, through Cardiovascular Cell Therapy Research Network and funded by the National Heart, Lung and Blood Institute, are gearing up to launch three other multi-center studies within the next several months that use other types of a patient’s own stem cells.