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Hopkins begins human trials with donor adult stem cells to repair muscle damaged from heart attack

lts who have had their first heart attack within 10 days of enrollment in the trial. All patients will have been stabilized before acceptance to the trial, and have undergone cardiac catheterization and ultrasound echocardiography to check that their main coronary vessels are clear of blockages that may precipitate another heart attack.

Eligible candidates must be able to safely travel to Hopkins Hospital in Baltimore, Md., be referred by a physician, be between 21 and 85 years old, and have no pre-existing heart condition that has been treated or requires treatment during the study period. Physicians interested in referring patients should call tel. 410-955-1160 for further information.

Upon acceptance in the study, patients will be randomly assigned to one of four groups, each made up of 12 patients who will receive a preset dose of stem cell therapy or placebo. The study is double blinded, with neither researchers nor patients aware of who received stem cells until the Phase I study ends, six months after the last patient has enrolled.

After injecting stem cells taken from the bone marrow of an adult, human donor, into subjects' bloodstream, the researchers will monitor the patient's progress for two years to ensure that patients safely tolerated the infusion, determine any side effects and assess any differences in the three doses under study, each involving millions of adult stem cells. Initially, study participants will spend four days in the hospital, immediately after the procedure. The patients will then return for preset checkups, monthly for the first three months, and again after six months, 18 months and 24 months.

Magnetic resonance imaging (MRI) studies, to show the size of the area of heart muscle scarred by the infarct and gauge the organ's ability to pump, will be conducted at the beginning and end of the study as a measure of heart function. Conclusive results will only be available when and if P
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Contact: David March
dmarch1@jhmi.edu
410-955-1534
Johns Hopkins Medical Institutions
25-Mar-2005


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