Cytori Therapeutics has treated first US patient in the ATHENA trial using the company's cell therapy based on patient's own adipose-derived stem and regenerative cells (ADRCs).
ADRCs are processed using the company’s proprietary Celution system technology and are used to minimize the risk of rejection in patients with a severe form of refractory (untreatable) heart failure due to chronic myocardial ischemia.
Minneapolis Heart Institute Foundation research director and study co-principal investigator Timothy Henry said patients with refractory heart failure have no options except for heart transplant.
"Cell therapy such as Cytori’s has the potential to delay, halt, or even reverse this progression," Henry added.
"We believe this is accomplished by the cells’ ability to promote angiogenesis and regulate the immune response to help revive damaged tissue that is alive yet not necessarily contributing to its fullest capacity toward the pumping ability of the heart."
The double-blind, multi-center, prospective, device-based PMA/IDE feasibility (Phase I/II) trial, which will enroll 45 patients, will randomize them to receive either Cytori’s cell therapy (n=30) or an inactive placebo injection (n=15).
Measurements of Peak oxygen consumption (VO2 Max), perfusion defect, left ventricle end-systolic and diastolic volume and ejection fraction at six and 12 months are the endpoints for the trial.
In addition, the trial will evaluate medical economic factors such as rate of re-hospitalization and heart failure symptoms such as angina and quality of life at 12 months.
The company said the trial is expected to complete enrollment in mid-2013.