Study: Novel Human-Derived ''Blood Vessels'' Durable In Vivo And Off-the-Shelf

Main Category: Cardiovascular / Cardiology
Also Included In: Medical Devices / Diagnostics
Article Date: 07 Nov 2007 - 14:00 PDT

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Humacyte announced that data presented at the American Heart Association Scientific Sessions demonstrates the longevity and durability of acellular arterial bypass grafts. Company scientists, working with researchers at Eastern Carolina Heart Institute, showed the potential for the naturally-derived vascular devices to provide a commercially viable solution for patients requiring vascular replacement or vascular access.

In the studies, scientists began by seeding smooth muscle cells on a tubular biodegradable scaffold, which produced extracellular matrix (ECM) proteins in the shape of blood vessels. Following a two month growth period, researchers removed the smooth muscle cells, leaving behind the intact ECM, thereby making them universally compatible. The removal of cells further provides the vessels with a significant shelf-life for off-the-shelf applications. The acellular grafts were surgically implanted in adult canines either as a carotid or coronary bypass grafts. The arterial bypass grafts were found to be functional for up to 12 months in the canine recipients. They remained clear of obstructions for the length of the study, and demonstrated no vessel narrowing, dilatation, or calcification.

"The data are very compelling and demonstrate for the first time that completely human, acellular vascular devices can be quickly grown, stored for long periods of time and implanted on an as-needed basis in any patient," said Dr. Niklason. "This provides a potentially significant alternative to synthetic grafts, which are associated with adverse events including blood clots and intimal hyperplasia, as well as newer autologous technologies that require expensive and lengthy culture periods. We believe these grafts have an important potential role in addressing human vascular disease because they can be used on an off-the-shelf basis by physicians, and they're acellular, eliminating the risk of tissue rejection."

"The study findings provide the foundation for the launch of additional studies of natural, acellular large-diameter peripheral grafts," said Humacyte CEO Geff Erickson, Ph.D., "which will support an eventual filing with the Food and Drug Administration."

About Humacyte

Humacyte grows medical devices from human cells. In a patented cell-based production and decellularization process, Humacyte creates entirely natural, allogeneic, products that are designed to integrate easily within the body and act as replacement tissues. The company's products can be produced in large quantities and stored for universal patient use as needed by physicians. For more information, please visit http://www.humacyte.com.