MedicalResearch.com Interview with:
Timothy D. Henry, MD, MSCAI
Director, Division of Cardiology
Cedars-Sinai Heart Institute
MedicalResearch.com: What is the background for this study? What are the main findings?
Dr. Henry: Heart failure it the #1 cause of morbidity, mortality and cost in the United States today. Patients with Class 3 heart failure, despite optimal medical therapy and device therapy have limited options beyond heart transplantation and left ventricular cyst device.
Transplantation and LVAD are expensive and are challenged by both availability and complications. Therefore, treatment for patients with ongoing symptoms despite medical therapy is an admiral goal. Stem cell therapy appears to be an attractive choice for these patients, in particular patients with ischemic cardiomyopathy.
The ATHENA trial was designed to treat patients with ischemic cardiomyopathy and ongoing ischemia with autologous adipose-derived regenerative cells. Patients would undergo liposuction with onsite processing of their stem cells in 1 ½ – 2 hours, followed by intramyocardial injection of adipose-derived regenerative cells (ADCRs) vs. placebo.
MedicalResearch.com: What should readers take away from your report?
Dr. Henry: Unfortunately, the trial stopped early due to transient ischemic attacks and a pre-specified stopping rule. Therefore the trial was abbreviated to 31 patients.
It demonstrated an improvement in Minnesota living with heart failure questionnaire, quality of life measured by SF36 as well as strong trends for symptoms, MVO2 and reversible ischemia. There was no significant improvement in LVEF.
Overall the trial indicates that autologous adipose-derived regenerative cells appear to be an attractive option for patients with ischemic cardiomyopathy.
Hopefully these results provide the framework for a larger double-blind placebo controlled trial.
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Citation: Abstract presented at the 2016 Society for Cardiovascular Angiography and Interventions Meeting
Dr. Henry presented “Final Results for THE ATHENA TRIALS: Autologous Adipose Derived Regenerative Cells (ADRCs) for Refractory Chronic Myocardial Ischemia with Left Ventricular (LV) Dysfunction” on Thursday, May 5, 2016 at 11:00 a.m. ET.
This study was simultaneously published online in Catheterization and Cardiovascular Interventions, the official publication of SCAI, at the time of presentation.
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