Amorcyte, Inc. , a biotechnology company developing cell therapy products to treat cardiovascular disease has announced that its phase I clinical trial 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.
The trial has recently been opened at Vanderbilt University School of Medicine under Douglas E. Vaughan, MD, FACC, Chief, Division of Cardiovascular Medicine, and at Texas Heart Institute at St. Luke's Episcopal Hospital 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, FACC.
"All treatment patients in the first cohort received intra-coronary artery infusion of a specified number of stem cells. The DSMB 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.”
He continued, “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.