By OMAR FORD
Medical Device DailyStaff Writer
Cytori Therapeutics (San Diego) reported the initiation of the FDA approved ATHENA clinical trial to investigate Cytori's cell therapy in patients who suffer from a severe form of refractory (untreatable) heart failure due to chronic myocardial ischemia.
Cytori's cell therapy is based on a patient's own adipose-derived stem and regenerative cells (ADRCs) processed by the company's proprietary Celution System technology, making this what the company calls the first FDA approved trial in the U.S. to evaluate ADRCs for cardiovascular disease.
This first patient was treated by co-principal investigator Timothy Henry, MD, director of research, at the Minneapolis Heart Institute Foundation in September and has undergone a seven day follow-up assessment.
"The patients who are enrolled in the study will all undergo a minor liposuction procedure, where they will have approximately 100 ccs maybe a little bit more worth of fat taken out," Thomas Baker, director of investor relations for Cytori told Medical Device Daily. "That fat or adipose tissue will be put into our automated system to separate the stem and regenerative cells that exist within fat tissue. What you're left with is a heterogeneous population of cells, that we refer to as stem and regenerative cells and those cells are injected back into the heart muscle."
ATHENA is a device-based, multi-center, prospective, randomized, double-blind PMA/IDE safety and feasibility (Phase I/II) trial that will enroll 45 patients in six centers in the U.S. Patients will be randomized to receive either Cytori's cell therapy (n=30) or an inactive placebo injection (n=15). All trial participants will undergo a minor liposuction procedure to remove adipose tissue. The adipose tissue will then be processed at the point-of-care with Cytori's proprietary system to separate and concentrate clinical-grade ADRCs. The treatment group will have a prescribed dose of the patient's own ADRCs (.4 million cells/kg body weight), which will then be injected into their damaged heart tissue using a minimally invasive catheter system.
"Cytori's cell therapy has unique advantages compared to alternate cell sources such as bone marrow and peripheral blood," said Emerson Perin, MD, PhD of The Texas Heart Institute (Houston) and co-principal investigator for ATHENA. "Specifically, it's a proprietary formulation that Cytori has optimized for vascular delivery and which contains an uncultured and mixed population of cells. 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 trial will measure several endpoints, including peak oxygen consumption (VO2 Max). VO2 Max is an objective functional measurement that can be predictive of outcomes in heart disease, including mortality, and is commonly used as a primary determinant for qualifying patients for heart transplantation. Additional endpoints include perfusion defect, left ventricle end-systolic and diastolic volume and ejection fraction at six and 12 months. ATHENA will also evaluate medical economic factors such as rate of re-hospitalization and heart failure symptoms such as angina and quality of life at 12 months.
Completion of enrollment for the study is still a ways off, according to Baker. But initial data could come in about six months.
"We expect to completely enrollment in the study by the first half of 2013," he said. "This means we should be able to report data from the study on the six month endpoint by early 2014. Based on that data we would be able to enter into a pivotal [trial]."
The device is approved in Europe for soft tissue applications, such as breast reconstruction.
Previously, Cytori reported six and 18-month safety and feasibility data from the PRECISE trial, a European clinical trial for this same indication. The PRECISE trial demonstrated a statistically significant improvement in VO2 Max in patients treated with Cytori's cell therapy compared to those treated with placebo. The company said that it is also conducting the ADVANCE trial, a European pivotal trial investigating the effect of Cytori's cell therapy in heart attack patients.
"We believe Cytori's cell therapy will improve patient outcomes," said Marc Hedrick, MD, president, Cytori Therapeutics. "In ATHENA, investigators will be delivering a virtually 'off-the-shelf' cell therapy comprised of a patient's own cells, which is made possible by our technology. Using a patient's own cells minimizes the risk of rejection or disease transmission compared to alternative therapies derived from donor cells and the virtually off-the-shelf nature allows the treatment to be accomplished in a single surgical procedure."
Omar Ford, 404-262-5546;
Published October 12, 2012