Oct. 18, 2006
UI Health Care Researchers To Study Cardiac Stem Cells
University of Iowa Hospitals and Clinics leaders announced today that it is one of the first medical centers in the country participating in a novel clinical trial investigating if a patient's own stem cells can treat a form of severe coronary artery disease.
Researchers in the Division of Cardiology in the UI Department of Internal Medicine and the UI Department of Pathology are collaborating to enroll participants 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 subjects 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," said Mark Anderson, M.D., Ph.D., the Potter-Lambert Chair in Cardiology, director of the UI Division of Cardiology and associate director of the Cardiovascular Research Center. "A person diagnosed with chronic myocardial ischemia continues to experience insufficient flow of oxygen-rich blood to the heart despite optimum medical intervention."
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.
UI Hospitals and Clinics and the UI Roy J. and Lucille A. Carver College of Medicine represent one of 15 to 20 research sites nationwide participating in the study. The state's lone comprehensive academic medical center is the only facility in Iowa conducting the investigational trial. The Cellular Therapies business unit of Baxter Healthcare Corporation is sponsoring the research.
The first step in the ACT34-CMI trial is to establish the baseline frequency and severity of anginal episodes for all study subjects. Next, all subjects receive a series of subcutaneous injections (needle shots, typically delivered under the skin in the arm, thigh or abdomen) of a commercially produced protein (granulocyte colony stimulating factor). The protein helps to release blood-forming CD34+ cells from a subject's bone marrow into the bloodstream.
Then, investigators use a cell separation system, similar to the automated systems that are used with people who donate specific blood components such as platelets or red blood cells, to collect from the subject's bloodstream an enriched preparation of cells that contain CD34+ stem cells. When this process, known as apheresis, is complete, technologists further process the collected stem cells with Baxter's ISOLEX 300i Magnetic Cell Selection System, currently approved for use with cancer patients, to select the CD34+ stem cells for use in this investigational therapy.
Subjects are randomly selected to receive either one of two dosing levels of CD34+ stem cells, or placebo. UI Health Care researchers will conduct follow-up examinations for 12 months following the investigative procedure.
Coronary artery disease is the most common form of heart disease and is the leading cause of death in the United States. This condition occurs when the coronary arteries and the smaller vessels that supply oxygen-rich blood to the heart muscle become narrowed or blocked by plaque deposits and blood clots. Poor blood flow and blood clots "starve" and injure the heart muscle.
The American Heart Association estimates that every year, between 125,000 and 250,000 individuals with coronary artery disease develop chronic myocardial ischemia (CMI), one of the most severe forms of coronary artery disease. CMI develops when the coronary arteries become so diseased that they limit the flow of blood to the heart and send small blood clots downstream, blocking the small blood vessels in the heart. These blockages can result in a series of mini-heart attacks that, while maybe too small to notice at the time, in aggregate cause significant long-term damage to the heart muscle and disability to the patient. While cardiologists can restore blood flow in some cases, the heart muscle can be irreversibly damaged, leading to significant disability, progressive heart failure and often death.
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