FDA-Approved Clinical Trial to Test Effectiveness of
Regenerative Cells on Heart Failure Patients
Texas Heart Institute Among Heart Centers Selected in U.S.
HOUSTON, TEXAS (May 29, 2013) - Doctors
at the Texas Heart Institute (THI) at St. Luke's Episcopal Hospital (SLEH) announced
that they have performed an investigational procedure on six patients in a new
FDA-approved clinical trial to evaluate therapy that uses regenerative cells
derived from a patients' own adipose (body fat) tissue to treat a severe form
of heart failure.
trial, known as ATHENA, marks the first such study in the U.S. using adipose-derived
regenerative cells, known as ADRCs, which are harvested using a technology
developed by Cytori Therapeutics, a biotechnology company that specializes in cell
therapies. Previous studies in Europe have shown the safety and feasibility of
"We have found that body
fat tissue is a valuable source of regenerative stem cells that are relatively easy to access," said Dr. James T. Willerson, THI's
president and medical director and a principal investigator in the trial. "We
have high hopes for the therapeutic promise of this research and believe that it
will lead quickly to larger trials."
trial involves patients suffering from chronic heart failure due to coronary heart disease which blocks blood flow to the heart, reduces the heart's oxygen
supply, and limits its pumping function. According to the American Heart
Association, there are approximately 5.1 million Americans currently living
with heart failure. In many cases, the
only viable treatment is a left ventricular assist device (LVAD) or a heart
transplant. Due largely to a shortage of donor hearts, the U.S. sees an average
of only about 2,200 heart transplants yearly.
enrolled in the U.S. trial will be randomized and some will receive the cell
therapy, while others will receive a placebo. All participants will undergo a
minor liposuction procedure to remove the adipose tissue, which will then be
processed to extract ADRCs. The ADRCs or a placebo will then be injected into
the patient's heart. The trial will measure several endpoints, including
objective measures of heart function, exercise capacity and questionnaires
assessing symptoms and health-related quality of life.
U.S. trial will enroll a total of 45 patients at several centers around the
country. In addition to the THI, the Minneapolis Heart Institute, Scripps Green
Hospital in San Diego, the University of Florida at Gainesville, and Cardiology
P.C. in Birmingham are currently enrolling patients.
interested in learning more about the ATHENA clinical trial can call
+1.866.924.STEM (7836) or visit www.theathenatrial.com.
For media inquiries please contact:
Director of Public Affairs
Texas Heart Institute
Frank Michel ♦ 832-355-9510 ♦ email@example.com
For THI media profile, see Public Affairs.