Florida Hospital Investigates the Potential for Stem Cell Repair

Florida Hospital Investigates the Potential for Adult Stem Cells to Repair Hearts Damaged by Severe Coronary Artery Disease

Trial Involves Injecting Patients' Own Stem Cells into Areas of Their Hearts with Poor Blood Flow

 ORLANDO, Fla., April 4, 2007 - Florida Hospital is one of the first medical centers in the country to participate in a new clinical trial investigating whether patients' own stem cells can treat a form of severe coronary artery disease.  Florida Hospital Orlando is enrolling patients in the Autologous Cellular Therapy CD34-Chronic Myocardial Ischemia (ACT34-CMI) Trial.  ACT34-CMI is the first human Phase II adult stem cell therapy study in the United States 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.

Myocardial ischemia 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 people each year. Patients who suffer from chronic myocardial ischemia continue to experience insufficient flow of oxygen-rich blood to the heart despite optimum medical intervention.    

"This trial offers a possible treatment for patients who have exhausted all other treatment options and still do not have an acceptable quality of life.  It is also promising on a larger scale because if it has a positive outcome and proves to regenerate vessels, it could open the door to treating patients in the future with autologous stem cells in conjunction with other currently available treatments," said Andrew Taussig, MD, cardiologist and principal investigator for the trial at Florida Hospital. 

ACT34-CMI is a prospective, randomized, double-blind, placebo-controlled study that involves adult subjects with severe coronary artery disease 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.

Florida Hospital is one of fewer than 20 research sites nationwide participating in the study, which is sponsored by the Cellular Therapies Business Unit of Baxter Healthcare Corporation.  Baxter technology is used to select the subject's own CD34+ stem cells that are under investigation in this trial. 

Subjects are randomly selected to receive either one of two dosing levels of CD34+ stem cells, or placebo. Florida Hospital researchers will conduct follow-up examinations for 12 months following the investigative procedure. 

For more information, contact Florida Hospital Media Relations at 407-303 8217.

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