The FDA-approved ATHENA trial is the brainchild of stem cell researchers at the Texas Heart Institute at St. Luke’s Episcopal Hospital. The ATHENA trial is the first trial in the United States to examine the efficacy of adipose-derived regenerative cells or ADRCs as a treatment for a severe form of heart failure.
To harvest ADRCs, Texas Heart Institute researchers used a technique that was developed by Cytori Therapeutics, which is a biotechnology company that specializes in cell-based regenerative therapies. Previous clinical trials in Europe strongly suggest that such ADR-based therapies are quite safe and feasible. To date, physicians are the Texas Heart Institute have treated six patients as a part of the ATHENA trial.
James Willerson, the president and medical director of the Texas Heart Institute, is the principal investigator in the ATHENA trial. Willerson said, “We have found that body fat tissue is a valuable source of regenerative stem cells that are relatively easy to access. We have high hopes for the therapeutic promise of this research and believe that it will lead quickly to larger trials.”
The subjects for the ATHENA trial are patients who suffer from chronic heart failure due to coronary heart disease. Coronary heart disease results from blockage of the coronary vessels and feed the heart muscle and limits the oxygen supply to the heart muscle, and consequently, the pumping activity of the heart muscle. Data from the American Heart Association reveals that there are about 5.1 million Americans who currently live with heart failure, and in many cases, the only viable treatment is a left ventricular assist device (LVAD) or a heart transplant. Unfortunately, there are only about 2,200 heart transplants a year due to a severe shortage of organs.
Patients who are enrolled in the ATHENA trials are randomized and some will receive a placebo treatment and others will receive the experimental treatment. All patients will undergo liposuction in order to remove adipose or fat tissue. Processing of the fat tissue isolates the ADRCs, and the experimental patients will have these cells injected directly into their heart muscle, but the placebo patients will receive injections of culture medium or saline that contains no cells. ATHENA will measure several data endpoints that include objective measures of heart function, exercise capacity, and questionnaires that assess the symptoms and health-related quality-of-life.
The US trial will enroll a total of 45 patients at several centers around the country and these centers include the Texas Heart Institute, Minneapolis Heart Institute, Scripps Green Hospital in San Diego, CA, the University of Florida at Gainesville, and Cardiology P.C. in Birmingham. Patients are being enrolled.
Healthline has recently compiled the statistics on heart disease in an impressive and colorful manner at this link.