Doctors at the Texas Heart Institute (THI) and St. Luke’s Episcopal Hospital (SLEH) in Houston, Texas, have completed an investigational procedure on six patients with chronic heart failure in a FDA-approved clinical trial to evaluate the therapeutic effectiveness of adipose-derived regenerative cells (ADRCs).
The “ATHENA” clinical trial is the first study in the United States using ADRCs invented by Cytori Therapeutics, a biotechnology company providing innovative regenerative therapies. In a previous study, the trial “PRECISE” in Europe showed the safety and the potentiality of the cells as an effective therapy for heart failure.
Dr. James T. Willerson, THI’s president and medical director and a principal investigator in the trial, commented: “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.”
In the ATHENA trial, patients suffering from chronic heart failure due to coronary heart disease were examined. First, patients underwent a liposuction procedure to remove a little over a cup of their own fat, from which the ADRCs are extracted from the fat. Patients then were randomly injected either with ADRCs or a placebo into their damaged heart tissue using a catheter system. The measurements of the patients’ heart function such as peak oxygen consumption, perfusion defect, and ejection fraction were taken several times over the course of twelve months after injection, along with extensive follow-up interviews about symptoms and health-related quality of life.
In the ATHENA trial, 45 patients were enrolled around the country: Texas Heart Institute, the Minneapolis Heart Institute, Scripps Green Hospital in San Diego, the University of Florida at Gainesvillem and Cardiology P.C. in Birmingham are currently enrolling patients.
Further Reading About ATHENA, PRECISE, & Adipose-Derived Regenerative Cells
Cytori – ATHENA trial, summary
Cytori – PRECISE trial, details and results