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Promising Results Reported in First U.S. Clinical Trial Investigating the Use of Adult Stem Cells for Severe Coronary Artery Dis

Posted Oct 04 2009 11:11pm
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DALLAS, Nov. 16 /PRNewswire/ -- Researchers from three major academic medical centers reported promising results gleaned from the initial phase of the first U.S. clinical trial investigating the benefit of using a patient's own (autologous) selected adult stem cells, called CD34+ cells, to treat coronary artery disease. Douglas Losordo, MD, chief of cardiovascular research at Caritas St. Elizabeth's Medical Center in Boston, shared the preliminary results of the trial during an oral presentation at the annual meeting of the American Heart Association in Dallas.

Over the past two years, 24 patients suffering from disabling angina attacks -- the most severe chest pain -- participated in the randomized, double-blind, FDA-approved study at three sites: Caritas St. Elizabeth's Medical Center in Boston, Scripps Clinic in La Jolla, Calif., and the Minneapolis Heart Institute. After six months of follow up, more than 80 percent, or 15 of the 18 patients who received the autologous adult stem cells, reported feeling better with reductions in chest pain and improved exercise capacity.

"Generally in a Phase I pilot study we are limited to assessing the safety of the protocol, since the number of patients included is generally too small to make observations regarding a treatment effect," said Dr. Losordo. "We were very pleasantly surprised to learn that the autologous adult stem cells were not only well tolerated, but also appeared to show evidence of benefit. While this is very early in the clinical trial process, we are cautiously optimistic as we move into a 150-patient, national multi-site Phase II trial early next year."

The American Heart Association estimates that between 125,000 and 250,000 individuals with coronary artery disease develop refractory angina each year. These individuals have exhausted all available treatment options including bypass surgery, angioplasty and stenting, and continue to have disabling angina despite medical treatment. Patients eligible to participate in this trial suffer from the most severe cases of disabling angina attacks or chest pain (class three or four angina). Due to their disease, these individuals are often substantially disabled, suffering severe chest pain with normal or no activity. Their condition substantially limits daily activities, making a routine walk to the mailbox nearly impossible.

The new procedure involves collecting adult autologous stem cells from the patient's own blood, all but eliminating rejection issues by the body. A device is used to process the stem cells collected from the patient, which allows for the selection of CD34+ adult stem cells that are free of surface contaminants, before the stem cells are injected back into the patient. Baxter Healthcare Corporation, a sponsor of this clinical study, provides the technology utilized to purify the autologous adult stem cells. Once the CD34+ cells are selected, interventional cardiologists use a catheter-based, non- surgical system to inject the cells into the heart muscle, where they may help to grow new blood vessels.

For more information on the trials and the enrollment procedure, please phone 1-888-311-4363.

Caritas St. Elizabeth's Medical Center, located in Boston, is a major academic medical center affiliated with Tufts University School of Medicine. Areas of medical excellence include cardiology and cardiovascular research, bone and joint health, gastroenterology, hematology/oncology, neurology, pulmonary medicine, and women's health and high-risk obstetrics. Caritas St. Elizabeth's is a member of Caritas Christi Health Care, the second largest health care system in New England.

Founded in 1924, Scripps Clinic is a multi-specialty, outpatient care facility caring for patients at multiple locations throughout San Diego County including Torrey Pines, Del Mar, Carmel Valley, Encinitas, La Jolla, Rancho Bernardo, Rancho San Diego, San Diego and Santee. Scripps Clinic and its physicians are world-renown for research-driven care and medical specialty expertise and is an operating unit of Scripps Health, a not-for-profit, community-based health care delivery network that includes more than 2,600 affiliated physicians, five acute-care hospitals, home health care and associated support services. Scripps Health is one of the largest health care organizations in San Diego County, drawing from the expertise of more than 10,000 health care professionals.

The Minneapolis Heart Institute Foundation is an independent, not-for- profit, community-based research and education organization founded in 1982 by the physicians of the Minneapolis Heart Institute. In addition to numerous ongoing research programs, the Foundation offers a wide range of community education programs in cardiac health for thousands of individuals each year. For the newest developments in the prevention, diagnosis, and treatment of cardiovascular disease, as well as the latest activities of the Foundation, visit our Web site at http://www.mplsheartfoundation.org/ .

Baxter Healthcare Corporation is the principal U.S. operating subsidiary of Baxter International Inc. . Baxter 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/ .

Women's Natural Health Center
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