Cytori Therapeutics has treated the first US patient in its ATHENA trial using the company’s cell therapy based on patient’s own adipose-derived stem and regenerative cells (ADRCs).
ADRCs, which are processed using the company’s proprietary Celution system technology, are used to minimise the risk of rejection or disease transmission 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 Dr Timothy Henry said patients with refractory heart failure typically have no option except a heart transplant.
"Cell therapy such as Cytori’s has the potential to delay, halt, or even reverse this progression," Henry said.
"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-centre, prospective, device-based PMA/IDE feasibility (Phase I/II) trial will enroll 45 patients and randomise them to receive either Cytori’s cell therapy (n=30) of patient’s own ADRCs (0.4 million cells/kg body weight) 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-hospitalisation, heart failure symptoms such as angina and quality of life at 12 months.
Texas Heart Institute spokesperson and ATHENA co-principal investigator Dr Emerson Perin said Cytori’s cell therapy has several advantages compared to alternate cell sources such as bone marrow and peripheral blood.
"Specifically, it’s a proprietary formulation that Cytori has optimised for vascular delivery and which contains an uncultured and mixed population of cells," Perin said.
"As a result, this increases the number of cell types that potentially contribute to repair relative to a more homogenous population of cultured cells."
The company said the trial is expected to complete enrolment in mid-2013.