PUBLIC RELEASE DATE:

13-Mar-2014

Contact: Toni Baker tbaker@gru.edu 706-721-4421 Medical College of Georgia at Georgia Regents University

Augusta, Ga. Researchers want to know whether patients with debilitating heart failure can benefit by having their own stem cells injected into their ailing heart muscle.

The severe condition is ischemic dilated cardiomyopathy, a currently incurable condition resulting from significantly compromised blood flow to the heart muscle as well as heart attacks, which leave the muscle bulky and inefficient and patients unable to carry out routine activities.

"We want to know if stem cell therapy is an option for patients who have essentially run out of options," said Dr. Adam Berman, electrophysiologist at the Medical College of Georgia at Georgia Regents University and Director of Cardiac Arrhythmia Ablation Services at Georgia Regents Health System. "It's a very exciting potential therapy, and these studies are designed to see if it works to help these patients."

Berman is a Principal Investigator on the multi-site study in which stem cells are removed from the bone marrow, their numbers significantly increased by technology developed by Aastrom Biosciences, then injected into multiple weak points in the heart. At GR Health System, the procedure is performed in the Electrophysiology Lab where Berman threads a catheter into an artery from the groin into the heart. Three-dimensional maps of the heart are created to provide a clear picture of its natural geography as well as major sites of damage.

"Everyone's heart is different, their scar burden is different, everything is different," Berman said. From that vantage point, small needles - similar in size to those used for skin testing - are used to make about 12 to 20 strategic injections of mesenchymal stem cells, which can differentiate into a variety of cell types. In this case, researchers hope the cells will improve blood flow and function of the heart.

Half of the study participants receive the stem cell treatment called ixmyelocel-T and the remainder a saline placebo. Patients go home the next day but researchers follow all participants for 12 months to assess heart function and quality of life. GR Health System plans to enroll a handful of patients in the clinical trial.

Treatment options for heart failure include frontline therapies such as diuretics to more extreme measures such as implantable ventricular assist devices and heart transplants.

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