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Clinical Trial Under Way Testing Stem Cell Heart Treatment

Human heart and arteries (Yale School of Medicine/Wikimedia Commons)

(Yale School of Medicine/Wikimedia Commons)

Cytori Therapeutics, a biotechnology company in San Diego, reports the first patient received treatment in its clinical trial using stem cells derived from body fat to treat severe heart failure. The patient was treated in September at the Minneapolis Heart Institute Foundation in Minneapolis, one of six sites for the trial, and completed a seven-day follow-up evaluation.

The trial, known as ATHENA — short for Adipose-derived stem and regenerative cells in the Treatment of patients with chronic ischemic Heart disease Not Amenable to surgical or interventional revascularization — tests the safety and feasibility of using stem cells from adipose or body fat to treat patients with a severe form of untreatable heart failure, due to inadequate heart muscle blood flow and lower pumping function. In many cases, the only viable treatment option for these patients is a heart transplant.

In the trial, 30 randomly selected patients will receive Cytori’s stem cell therapy, while 15 receive an inactive placebo injection. All trial participants will undergo a minor liposuction procedure to remove adipose tissue, which will then be processed by Cytori’s system to produce clinical-grade stem cells. Patients in the treatment group will get a dose of their own stem cells equivalent to 400,000 cells per kilogram of their own weight, injected into their heart tissue through a catheter.

The trial will measure peak oxygen consumption, shown to predict heart disease outcomes, such as mortality, and is commonly used as a factor to qualify patients for heart transplants. In addition, ATHENA will evaluate other cardiac functions, as well as heart failure symptoms such as angina, rate of rehospitalization, and quality of life after one year.

“Patients with refractory heart failure have no options except for heart transplant, for which there are few hearts available,” says Timothy Henry, who is research director at Minneapolis Heart Institute Foundation, and co-principal investigator of the project. “Cell therapy such as Cytori’s has the potential to delay, halt, or even reverse this progression. We believe this is accomplished by the cells’ ability to promote angiogenesis [growth of new blood vessels] 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.”

In January, Cytori received FDA approval, in the form of an Investigational Device Exemption, to begin the trial. Enrollment is expected to be completed by mid-2013. Besides Minneapolis Heart Institute Foundation, Texas Heart Institute in Houston is screening patients for participation in the trial. Future sites for the trial include University of Florida in Gainesville, University of South Florida in Tampa, Scripps Green Hospital in San Diego, and Cardiology P.C. in Birmingham, Alabama.

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