Amorcyte Cardiac Cell Therapy Trial Passes First Stage and Opens Two New Sites.- Stem cell therapy stem cell therapy Cell therapy Molecular medicine A technology in which a person's own cells–eg, neuronal stem cells are triggered to revert to their primitive embryonic form, then redifferentiate into mature cells of various organs trial proceeds to next stage and opens in two new clinical centers - HACKENSACK, N.J. -- Amorcyte, Inc. (Amorcyte), a privately funded biotechnology company developing cell therapy products to treat cardiovascular disease Cardiovascular disease Disease that affects the heart and blood vessels. Mentioned in: Lipoproteins Test cardiovascular disease , announced today that its phase I clinical trial Noun 1. phase I clinical trial - a clinical trial on a few persons to determine the safety of a new drug or invasive medical device; for drugs, dosage or toxicity limits should be obtained phase I is now open in two new clinical sites and the data safety monitoring board has approved the trial going forward to the second stage using, as per the approved protocol, an increased number of stem cells stem cells, unspecialized human or animal cells that can produce mature specialized body cells and at the same time replicate themselves. Embryonic stem cells are derived from a blastocyst (the blastula typical of placental mammals; see embryo), which is very young . The trial has recently been opened at Vanderbilt University School of Medicine under Douglas E. Vaughan, MD, FACC FACC Fellow, American College of Cardiology , Chief, Division of Cardiovascular Medicine, and at Texas Heart Institute at St. Luke's Episcopal Hospital  This hospital-related article is a stub. You can help Wikipedia by [expanding it].St. with co-principal investigators Emerson C. Perin, MD, PhD, Director, New Cardiovascular Interventional Technology and James T. Willerson, M.D., president of the UT Health Science Center at Houston, and president-elect and medical director of the Texas Heart Institute. The Phase I trial has been open since June at the Emory University School of Medicine in Atlanta, Georgia under Principal Investigator, Arshed A. Quyyumi, MD, FRCP FRCP Fellow of the Royal College of Physicians. FRCP abbr. Fellow of the Royal College of Physicians , FACC. "All treatment patients in the first cohort received intra-coronary artery infusion of a specified number of stem cells. The DSMB DSMB Data & Safety Monitoring Board Clinical research A committee of independent clinical research experts who review data in ongoing clinical trials, ensuring that participants are not exposed to undue risk, and look for any differences in effectiveness reviewed all of the data on the first treatment group and gave approval to start accruing patients in cohort 2 at an increased pre-specified number of stem cells infused intra-coronary artery," said Dr. Thomas Moss, Amorcyte's Chief Medical Officer. Amorcyte's Chairman of the Board, Dr. Andrew L. Pecora, stated, "Entering into the second cohort of this study, we are pleased to bring on two new centers under the direction of investigators with unparalleled reputation in the field. Texas Heart Institute is one of the premier cardiac centers in the United States with a stellar international reputation. Vanderbilt has recently finished a state of the art cardiac center and is the premier center in Tennessee with patients referred from Kentucky, Indiana, Alabama and Mississippi. The addition of these two centers will significantly speed up patient accrual." Amorcyte is actively recruiting patients for the trial. Amorcyte expects patient accrual for its 40-patient Phase I clinical trial to be completed in early 2007. About Cardiovascular Disease It is estimated that each year there are approximately 1.1 million instances of acute myocardial infarctions, 12 million cases of chronic ischemia and 5 million occurrences of congestive heart failure congestive heart failure, inability of the heart to expel sufficient blood to keep pace with the metabolic demands of the body. In the healthy individual the heart can tolerate large increases of workload for a considerable length of time. in the United States. A significant percentage of these patients may benefit from additional therapies to ameliorate the symptoms of their disease. Therapies like those being developed by Amorcyte are under active investigation to determine safety and efficacy. About Amorcyte, Inc. Amorcyte, Inc is a therapeutics company pursuing cell-based therapies for cardiovascular diseases, reimbursable on a commercial scale for widespread clinical use. Amorcyte was incorporated in May 2005 and received approval to open its Phase I trial in September 2005. Watch for more information soon at www.amorcyte.com. |
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