November 19, 2013
NEW YORK, NY — Vascular access care is an emerging multi-disciplinary issue of modern medicine with significant technology progress. “Vascular access is responsible for significant morbidity and up to 40% of dialysis-related costs. Without vascular access, dialysis and oncology therapy simply cannot be achieved. However, vascular access is responsible for significant local and systemic hemodynamic changes,” notes Dr. Jeffrey Lawson, Professor of Surgery and Pathology, Duke University School of Medicine (Durham, North Carolina) today at the 40th Annual VEITHsymposium in New York.
Dr. Lawson delivered a presentation that described preclinical data on an innovative, investigational bioengineered blood vessel technology that is being developed to produce the first off-the-shelf, human-derived, investigational bioengineered vessel under development for hemodialysis applications. These preclinical data suggest that the technology being developed, subject to receiving regulatory approval, for use in patients with chronic kidney disease, has the potential to be associated with less vessel clotting and better bioincorporation if ongoing development is successful. Dr. Lawson said, “Chronic kidney disease is a major global health problem that affects 26 million Americans. Currently, there are more than 380,000 patients who require hemodialysis in the U.S.”
In 2012, an Investigational New Drug (IND) application was submitted to the U.S. Food and Drug Administration to conduct a multi-center U.S. clinical trial to assess safety and performance of the investigational bioengineered vessel in providing vascular access for dialysis in End-Stage Renal Disease (ESRD) patients. In a first-of-its-kind operation in the U.S., Dr. Lawson and his team helped create an investigational bioengineered vessel that was implanted into the arm of a kidney dialysis patient. Studies in Poland are already underway.
Dr. Lawson said, “This technology could represent a pioneering step forward in regenerative medicine. We hope this procedure of implanting investigational bioengineered vessels into patients in the U.S. clinical trial sets the groundwork for demonstrating how these blood vessels can be grown, how they can incorporate into a patient’s body, and how they can avoid being rejected immunologically. A blood vessel is really an organ – it’s a complex tissue. We start with this, and one day perhaps we may be able to engineer a liver or a kidney or an eye.” The investigational bioengineered vessel is the product of a 15-year collaboration between Dr. Lawson and Laura Niklason, M.D., Ph.D., Professor of Anesthesia and Biomedical Engineering, Yale University, co-founder of Humacyte and a former faculty member at Duke.
“The preclinical results have been encouraging,” said Dr. Lawson. “If the results are replicated in the clinic, and regulatory approval can be secured in the future, then we hope that the technology will be of significant benefit to dialysis patients.”
Follow-on development of this technology is planned in other vascular procedures, such as replacement or bypass of diseased vessels, vessels damaged by trauma or other vascular procedures, subject to review and approval by the FDA.
About VEITHsymposium: Now in its fourth decade, VEITHsymposium provides vascular surgeons, interventional radiologists, interventional cardiologists and other vascular specialists with a unique and exciting format to learn the most current information about what is new and important in the treatment of vascular disease.
The 5-day event features over 750 rapid-fire presentations from world-renowned vascular specialists with emphasis on the latest advances, changing concepts in diagnosis and management, pressing controversies and new techniques. To register to attend the VEITHsymposium, please visit www.VEITHpress.org or contact Pauline T. Mayer at 631.979.3780.