Stem cell trial seeks participants
By Laura Ungar • firstname.lastname@example.org • February 11, 2009
In the next couple of weeks, Louisville doctors plan to begin enrolling patients for what they are calling the world’s first clinical trial using adult cardiac stem cells to heal hearts.
(FYI – THIS IS THE 20th OR SO CLINICAL TRIAL IN THE WORLD USING ADULT CARDIAC STEM CELLS BUT THE FIRST IN THE US. – DG)
Doctors from the University of Louisville and Jewish Hospital & St. Mary’s HealthCare hope to treat 20 patients who are suffering from heart failure, have had a heart attack, and need to undergo cardiac surgery. They also hope to recruit 20 control subjects.
“The true protagonists of the trial are not the investigators but the patients,” study leader Dr. Roberto Bolli, Jewish Hospital Heart and Lung Institute Distinguished Chair in Cardiology, said at a press conference today.
“It is the patients who generously volunteer…and ultimately advance the frontiers of human knowledge.”
The trial uses adult stem cells taken from the patient’s own cardiac tissue. A small piece of tissue that is routinely removed during bypass surgery will be frozen and sent to colleagues at Brigham and Women’s Hospital and Harvard University in Boston so that stem cells can be isolated, expanded and prepared before being sent back to Jewish Hospital for use in trial participants.
After the patient recovers for three or four months, doctors will inject the person’s own stem cells directly into cardiac scar tissue using a minimally-invasive cardiac catheterization procedure that reaches the heart through a large artery in the leg. Potential side effects of that procedure include, among others, infection, bleeding, heart attack and stroke.
Doctors say side effects of the cardiac stem cells are unknown because it’s the first time they are being used, but there’s no risk of rejection because they are the patient’s own cells.
Officials said doctors will treat all those whose cardiac stem cells can be grown, while those whose stem cells fail to grow would fall into the control group.
People who want to learn more about this study may call 852-1837 or e-mail email@example.com or firstname.lastname@example.org