Participation is welcome in a task group that is developing a proposed new ASTM International standard for manufacturers of vascular graft tissue engineered medical products. WK21657, Guide for Characterization and Assessment of Vascular Graft Tissue Engineered Medical Products (TEMPs), is being developed by a task group under the jurisdiction of subcommittee F04.04 on Tissue Engineered Medical Products. The subcommittee and task group are part of ASTM International Committee F04 on Medical and Surgical Materials and Devices.
There are currently no guidelines for manufacturers of vascular graft TEMPs on how to characterize their products. Because of this situation, the industry often uses documents for vascular grafts that are not cell-seeded. However, the presence of live cells inside vascular TEMPs requires additional characterization, which will be covered in WK21657.
“Tissue-engineered vascular grafts are a very challenging product for manufacturers and there is minimal precedence for regulatory approval of such products by the FDA,” says Dr. Chrysanthi (Sandy) Williams, market manager, biomaterials and tissue engineering, Bose Corp., and an F04 member. “Therefore, this proposed guide is a first step in providing a resource that will help bring these products to market for patients.”
According to Williams, WK21657 will include information related to the functional characteristics of vascular graft TEMPs. “For example, academic researchers may perform a series of characterization tests and assays to thoroughly characterize a tissue engineered vascular graft, while a vascular graft TEMP manufacturer needs only to focus on assessing its safety and efficacy,” says Williams. “This distinction is important because live tissues are complex and dynamic; their properties change continuously as tissue remodeling is ongoing.”
Williams notes that the proposed standard will separate characterization tests and assays related to functionality from tests that are of academic interest. Primary users will include tissue engineering companies that are involved in the research and development of vascular grafts, as well as others involved in the production, delivery and regulation of vascular graft TEMPs. In addition, WK21657 will be of interest to academic researchers who work in this area, since there are currently no guidelines for standardizing the characterization of tissue engineered vascular grafts.
For technical Information, contact Chrysanthi (Sandy) Williams, Bose Corp., Eden Prairie, Minn. (phone: 952-278-3029; sandy_williams@bose.com). Committee F04 meets May 19-22, 2009, during the May committee week in Vancouver, British Columbia, Canada. For ASTM meeting or membership information, contact Daniel Schultz, ASTM International (phone: 610-832-9716; dschultz@astm.org).
Release #8129/Dec08
