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www.fdanews.com/articles/85135-baxter-begins-stem-cell-trial-in-for-severe-coronary-artery-disease

BAXTER BEGINS STEM CELL TRIAL IN FOR SEVERE CORONARY ARTERY DISEASE

March 8, 2006

Baxter Healthcare has initiated the first human Phase II adult stem cell therapy trial in the U.S. designed to investigate the efficacy, tolerability, and safety of blood-derived selected CD34+ stem cells to improve symptoms and clinical outcomes in patients with chronic myocardial ischemia (CMI), a severe form of coronary artery disease.

CMI is a serious heart condition that involves narrowing of coronary arteries and results in limited blood flow to the heart, affecting hundreds of thousands of new patients each year. This prospective, randomized, double-blind, placebo-controlled, multi-center study will involve approximately 150 adult patients who are currently on maximal medical therapy and are not suitable candidates for conventional procedures to improve blood flow to the heart, such as angioplasty, stents, or coronary artery bypass surgery.