Aldagen Announces Texas Heart Institute as First Site in its Stem Cell Clinical Trial to Treat Critical Limb Ischemia
Durham, NC – December 15, 2006 – Aldagen, Inc. today announced that the Texas Heart Institute at St. Luke’s Episcopal Hospital in Houston, Texas will be the first site for its clinical trial using Aldagen’s ALDESORT® product to isolate a unique stem cell population as therapy for critical limb ischemia (CLI) patients. The co-lead investigators at Texas Heart Institute on the study will be Dr. Emerson Perin and Dr. James Willerson.
“We are very excited to begin this study as it represents the first clinical study in the United States to use purified stem cells for the treatment of critical limb ischemia. We believe that these cells have the potential to offer CLI patients a new therapeutic option,” said Drs. Willerson and Perin. Dr. James Willerson is president-elect and medical director of the Texas Heart Institute at St. Luke’s and President of The University of Texas Health Sciences Center at Houston. Dr. Perin is director of New Cardiovascular Interventional Technology and director of the Stem Cell Center at the Texas Heart Institute at St. Luke’s.
About the Study
Aldagen’s clinical trial will involve 20 patients, all of which will have bone marrow extracted. Ten patients will receive multiple injections of the bone marrow directly into muscle in the ischemic leg and ten patients will receive multiple injections of stem cells isolated from the bone marrow using Aldagen’s ALDESORT product. The patients will be monitored for up to six months with a primary endpoint at three months. Endpoints will include safety and the ability of therapy to reduce rest pain, increase skin surface oxygen pressure and improve ulcer healing.
ALDESORT isolates a highly potent population of stem cells taken from the patient’s own bone marrow. These stem cells have the potential to build new blood vessels (angiogenesis) in ischemic legs, which could ultimately lead to improved functionality for CLI patients.
For more information on the study, call the Texas Heart Institute's Stem Cell Center at 832-355-9404, visit online at www.texasheart.org/stemcell or e-mail directly to plea@heart.thi.tmc.edu.
About Critical Limb Ischemia
Critical limb ischemia is a severe form of peripheral vascular disease (PVD). It is estimated that between eight to 12 million Americans suffer from PVD, which is a disease of the blood vessels characterized by narrowing and hardening of the arteries that supply the legs and feet. This causes a decrease in blood flow that can injure nerves and other tissues. CLI can lead to gangrene or tissue death, often necessitating amputation of the affected limb. Currently, there are no suitable alternatives to either percutaneous or surgical revascularization in patients with CLI. Despite some success of limb salvage with leg bypass, the condition remains associated with a substantial rate of morbidity and mortality and the need for subsequent surgery and hospitalization for wound complications is as high as 50%. There is a pressing need for the development of techniques to improve the vascular supply to ischemic leg by less invasive means.
About Aldagen, Inc.
Aldagen is a clinical-stage regenerative medicine company developing and commercializing products to treat vascular and degenerative diseases. The company’s proprietary products can identify and isolate potent, highly effective adult stem and progenitor cells which can be quickly administered to regenerate or repair tissue. The company’s lead product, ALDESORT, is currently being tested at Texas Heart Institute and Duke University in three clinical studies for ischemic heart failure, critical limb ischemia, and cord blood transplantation. To learn more about Aldagen’s products for preparing optimal cell populations for adult stem and progenitor cell therapy, the Company invites you to visit its website at www.aldagen.com.
About The Texas Heart Institute and St. Luke’s
The Texas Heart Institute, founded by world-renowned cardiovascular surgeon Dr. Denton A. Cooley in 1962, is a nonprofit organization dedicated to reducing the devastating toll of cardiovascular disease through innovative and progressive programs in research, education and improved patient care. Together with its clinical partner, St. Luke’s Episcopal Hospital, it has been ranked among the top ten cardiovascular centers in the United States by U.S. News & World Report’s annual guide to “America’s Best Hospitals” for the past 16 years. The Texas Heart Institute is also affiliated with the University of Texas (UT) System, which promotes collaboration in cardiovascular research and education among UT and THI faculty at the Texas Heart Institute and other UT components. For more information about the Institute, please visit www.texasheart.org.
St. Luke’s Episcopal Health System comprises the flagship St. Luke’s Episcopal Hospital in the Texas Medical Center, founded in 1954 by the Episcopal Diocese of Texas; St. Luke’s Community Medical Center–The Woodlands, opened in 2003; St. Luke’s Episcopal Health Charities, a charity devoted to assessing and enhancing community health, especially among the underserved; and Kelsey-Seybold Management, LLP, overseeing 21 area clinic locations. St. Luke’s Episcopal Hospital is home to the Texas Heart Institute, founded in 1962 by Denton A. Cooley, M.D., and consistently ranked among the top 10 cardiology and heart surgery centers in the nation by U.S. News and World Report. Affiliated with several nursing schools and two medical schools, St. Luke’s serves as the primary adult teaching hospital for Baylor College of Medicine. St. Luke’s was the first hospital in Texas named a Magnet hospital for nursing excellence, and the Health System has been recognized by FORTUNE as among “100 Best Companies to Work For” (2002, 2004 and 2005) and by Houston Business Journal as a top employer in Houston for three consecutive years.
For more information about Aldagen and ALDESORT, contact:
