FDA批准脂肪源再生细胞对心脏衰竭患者有效性的临床试验（附原文）

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+ c( ^5 `; Y3 R5 Q+ B! ZFDA-Approved Clinical Trial to Test Effectiveness of Fat-Derived Regenerative Cells on Heart Failure Patients  # D( T8 y/ a# T) Z8 ^- @+ X, w) B
Texas Heart Institute Among Heart Centers Selected in U.S.   1 N0 L0 U$ }1 K: @. R9 ^% [4 j0 g
HOUSTON, TEXAS (May 29, 2013) - Doctors at the Texas Heart Institute (THI) at St. Luke's Episcopal Hospital (SLEH) announced that they have performed an investigational procedure on six patients in a new FDA-approved clinical trial to evaluate therapy that uses regenerative cells derived from a patients' own adipose (body fat) tissue to treat a severe form of heart failure.
, V6 @8 J/ k. w: X/ q5 ~* ~; kThe trial, known as ATHENA, marks the first such study in the U.S. using adipose-derived regenerative cells, known as ADRCs, which are harvested using a technology developed by Cytori Therapeutics, a biotechnology company that specializes in cell therapies. Previous studies in Europe have shown the safety and feasibility of the therapy. " p( O& O- \2 N4 P9 [( v
"We have found that body fat tissue is a valuable source of regenerative stem cells that are relatively easy to access," said Dr. James T. Willerson, THI's president and medical director and a principal investigator in the trial. "We have high hopes for the therapeutic promise of this research and believe that it will lead quickly to larger trials."
2 m! @9 K& @2 c6 Q) }7 e# mThe trial involves patients suffering from chronic heart failure due to coronary heart disease which blocks blood flow to the heart, reduces the heart's oxygen supply, and limits its pumping function. According to the American Heart Association, there are approximately 5.1 million Americans currently living with heart failure.  In many cases, the only viable treatment is a left ventricular assist device (LVAD) or a heart transplant. Due largely to a shortage of donor hearts, the U.S. sees an average of only about 2,200 heart transplants yearly. # h* u/ a& g" V( U
Patients enrolled in the U.S. trial will be randomized and some will receive the cell therapy, while others will receive a placebo. All participants will undergo a minor liposuction procedure to remove the adipose tissue, which will then be processed to extract ADRCs. The ADRCs or a placebo will then be injected into the patient's heart. The trial will measure several endpoints, including objective measures of heart function, exercise capacity and questionnaires assessing symptoms and health-related quality of life. % W: Y* [  m- B2 [
The U.S. trial will enroll a total of 45 patients at several centers around the country. In addition to the THI, the Minneapolis Heart Institute, Scripps Green Hospital in San Diego, the University of Florida at Gainesville, and Cardiology P.C. in Birmingham are currently enrolling patients.  , c7 ?: J  U3 y# J/ [$ @
Those interested in learning more about the ATHENA clinical trial can call +1.866.924.STEM (7836) or visit www.theathenatrial.com.  
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