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Patient Enrollment Beginning for Adult Stem Cell Trial

Texas Heart Institute Announcement, May 1, 2009

The Stem Cell Center at the Texas Heart Institute at St. Luke's Episcopal Hospital in Houston has announced the commencement of FDA-approved Phase I clinical trials in which the Hospital is currently enrolling patients who have experienced any of three cardiovascular conditions, namely, a heart attack, heart failure or peripheral vascular disease. While patients will not be given monetary compensation for enrollment in the trials, they also will not be charged for any of the therapy or post-therapy monitoring that is conducted in relation to the trials.

The Stem Cell Center currently has several concomitant trials in which patients are being enrolled for heart failure. Qualifying patients must be on maximal medical therapy, exhibit a low ejection fraction, and have exhausted all conventional medical therapy such as bypass surgery and angioplasty. For the heart attack trials, qualifying patients must recently have been treated with angioplasty following a heart attack. For the peripheral vascular disease trials, in which adult stem cells will be injected directly into the affected areas of the leg, qualifying patients must exhibit claudication (blocked arteries in the legs) but no active infections in the leg, and must be refractive to conventional therapy.

Patients who wish to be considered for enrollment, and physicians who would like to refer a patient for consideration, should contact the Texas Heart Institute directly.

The Texas Heart Institute was founded in 1962 by the cardiac surgeon and pioneer, Dr. Denton Cooley, and today the Institute ranks as one of the largest cardiovascular centers in the world. As of 2008, doctors at the Texas Heart Institute had performed over 200,000 cardiac catheterizations, 100,000 open heart surgeries, and 1,000 heart transplants. Additionally, the Texas Heart Institute was one of only five centers selected by NIH (the National Institutes of Health) to study stem cell therapy as a treatment for cardiovascular disease, and the Stem Cell Center at the Texas Heart Institute was the first organization within the U.S. to receive FDA approval for a clinical trial in which advanced heart failure is treated with adult stem cells.



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