Using the facilities and expertise at Hoxworth Blood Center, stem cells—or “undifferentiated” cells that haven’t yet evolved into any specific tissue—from the study participant’s body will be harvested; those enrolled into the active arm of the study will have their stem cells injected into their heart muscle to examine the safety and efficacy of this as a potential future treatment.
One-fourth of those enrolled into the study will be randomly selected to the standard of care arm and will continue to receive high-quality cardiac care but will not undergo the stem cell injection procedure.
“We’re trying to determine if the stem cells will help to form new vessel networks, delivering blood flow to the heart and alleviating the symptoms of angina,” says Neal Weintraub, MD, Mabel Stearns Stonehill Chair of Cardiology, professor in the division of cardiovascular diseases and principal investigator on this study.
Angina is chest pain that occurs when the heart muscle doesn’t get enough oxygen-rich blood.
In the study, participants will undergo two exercise tolerance tests and self-report angina episodes for a 28-day screening period. Researchers are looking for male or female patients aged 21 to 80 who have been diagnosed with angina and have not been helped with conventional therapeutic options.
Those who meet the criteria to participate in the study will receive an injection into their heart muscle of either their own stem cells or placebo—an inactive fluid that does not contain stem cells.
“During the follow-up period, subjects will be contacted by telephone during Week One to collect safety information,” says Weintraub, who is also a UC Health cardiologist. “An in-person, two-week visit is scheduled for all participants.”
In addition, follow-up clinic visits will take place at five weeks and again at three, six, 12, 18 and 24 months; follow-up visits via telephone will take place at 15 and 21 months. Participants in the study must continue their daily activities and report angina episodes for up to one year.
“This will help us determine the ability and safety of using stem cells to increase exercise tolerance in this group of patients and possibly help treat their angina, improving their quality of life,” says Weintraub.
This study is funded by Baxter Healthcare; Weintraub cites no conflict of interest.
|Media Contact:||Katie Pence, 513-558-4561|
For more information, please call 513-558-0237. For questions or to find out about this and other cardiovascular diseases clinical trials, please call 513-558-2273 (CARD).