DEERFIELD, Ill., March 7 /PRNewswire-FirstCall/ -- Baxter Healthcare Corporation today announced that it 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.
"Baxter's sponsorship of this trial is consistent with our mission to be a leader in providing innovative life-saving therapies, and to pursue new opportunities where our technology can potentially help save and sustain lives," said Norbert Riedel, Ph.D., Baxter's chief scientific officer. "We're excited and privileged to work with world-class researchers in the field of cardiovascular disease to potentially satisfy this unmet medical need.
"We're pleased that our ISOLEX cell selection system is contributing to this area of research," Riedel continued. "Ultimately, our goal with this study is to advance the medical community's scientific understanding of the potential for autologous CD34+ cells to provide safe and effective outcomes for patients with a serious form of heart disease."
Ongoing Phase I Trial Shows Promise
Douglas Losordo, M.D., chief of cardiovascular research at Caritas St. Elizabeth's Medical Center in Boston, is the principal investigator of his institution's Phase I trial. While data from this multi-center trial have not been fully analyzed, researchers are encouraged by preliminary anecdotal patient reports. Of the 24 total study subjects, 16 reported feeling better with reductions in chest pain and improved exercise capacity during the early stage of the trial. Though not sufficiently powered to demonstrate efficacy, these promising results led directly to Baxter's decision to sponsor the Phase II trial. Dr. Losordo will be the lead investigator of the Phase II study.
"This trial is the culmination of nine years of research suggesting the potency of CD34+ cells for treating heart disease," said Dr. Losordo. "We are delighted that we are on the threshold of the next important phase of testing for this unique autologous stem cell therapy."
Phase II Trial Procedure and Enrollment
The first step in this trial is to establish the baseline frequency and severity of CMI for all study patients. Next, all patients receive granulocyte colony stimulating factor to mobilize the hematopoietic (blood- forming) CD34+ cells from their bone marrow to their bloodstream. Then, a cell separation system collects a mononuclear cell preparation rich in CD34+ stem cells from the patient's bloodstream. In the fourth step, Baxter's ISOLEX 300i Magnetic Cell Selection System selects the CD34+ stem cells that will be used in the investigational therapy. Interventional cardiologists then use a catheter-based, non-surgical system to inject the selected CD34+ cells into the areas of the heart that have poor blood flow. Researchers will conduct follow-up examinations with the patients for 12 months following the injection of their stem cells.
Baxter is recruiting 15-20 of the top cardiovascular research centers in the country to participate in the trial. At each site, patients will be randomly selected to receive either one of two dosing levels of CD34+ stem cells, or placebo. For more information, please call Baxter at 1-800-422- 9837.
Coronary Artery Disease and Chronic Myocardial Ischemia
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. In CMI patients, this can cause unstable angina, heart attacks and progressive heart failure when adequate blood flow is not restored. While cardiologists can restore blood flow in some cases, the heart muscle can be irreversibly damaged, leading to significant disability and often death.
One of the most severe forms of coronary artery disease is chronic myocardial ischemia. The American Heart Association estimates that between 125,000 and 250,000 individuals with coronary artery disease develop CMI each year. CMI develops when the coronary arteries become so diseased that they limit the flow of blood to the heart and send small emboli downstream, blocking the small blood vessels in the heart. These blockages can result in a series of mini-heart attacks which, while too small to notice at the time, in the aggregate cause significant long-term damage to the heart muscle and disability to the patient.
Baxter Healthcare Corporation is the principal U.S. operating subsidiary of Baxter International Inc. . Baxter International Inc., through its subsidiaries, assists healthcare professionals and their patients with treatment of complex medical conditions, including cancer, hemophilia, immune disorders, kidney disease and trauma. The company applies its expertise in medical devices, pharmaceuticals and biotechnology to make a meaningful difference in patients' lives. For more information about Baxter, please visit http://www.baxter.com .
Baxter Healthcare CorporationCONTACT: Media, Jed Weiner, +1-847-948-2815, or Deborah Spak,+1-847-948-2349, or Investors, Mary Kay Ladone, +1-847-948-3371, or ClareSullivan, +1-847-948-3085, all of Baxter
Web site: http://www.baxter.com/
