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6 at THI 29 May 2013 12:57 #513

  • myownhedgefund
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FDA-Approved Clinical Trial to Test Effectiveness of Fat-Derived Regenerative Cells on Heart Failure PatientsLast update: 5/29/2013 1:18:00 PMTexas Heart Institute Among Heart Centers Selected in U.S. HOUSTON, May 29, 2013 (BUSINESS WIRE) -- 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 patient's own adipose (body fat) tissue to treat a severe form of heart failure. The trial, known as ATHENA, marks the first such study in the United States 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. "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." The 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. 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. 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. Those interested in learning more about the ATHENA clinical trial can call +1.866.924.STEM (7836) or visit . About the Texas Heart(R) Institute The Texas Heart Institute (), founded by world-renowned cardiovascular surgeon Dr. Denton A. Cooley in 1962, is a nonprofit organization dedicated to reducing the devastating toll of cardiovascular disease through innovative and progressive programs in research, education and improved patient care. Together with its clinical partner, St. Luke's Episcopal Hospital, it has been ranked among the top 10 cardiovascular centers in the United States by U.S. News & World Report's annual guide to "America's Best Hospitals" for the past 22 years. The Texas Heart Institute is also affiliated with the University of Texas (UT) System, which promotes collaboration in cardiovascular research and education among UT and THI faculty at the Texas Heart Institute and other UT components
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6 at THI 30 May 2013 06:25 #514

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For whatever it is worth-

Assuming Minnesota was ahead by 4 patients= 10 and the other three Birmingham, Scripps and Florida did also 6 like St. Lukes- you get 34 in total by May end. Assuming 1 per month by each clinic- yes- they should make the summer with enrollment- early August probably. :winky:
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Board moderator and Site-owner. I still regret the day I started analysing the prospects of MacroPore (now Cytori) back in 2004- a left-over from the tech-bubble at that time from the century change in my portfolio- and became addicted to Cytori´s fat cell technology. :cry:

6 at THI 30 May 2013 19:38 #518

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Generally assuming you are correct Fas....I think we see the Athena data April / 2014.

Then they will have to design and get approval for the larger pivitol trial which I wouldnt expect the first patient to be treated til early 2015.

Hard to judge how long this pivitol trial could take.....if they get to stop early maybe US approval comes in 2016...if they have to do the full trial it may not be until 2017 assuming all goes well.

Still waiting for Jason K to get a dose of reality and adjust those 2020 cardiac numbers lower !!!

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