NDLI: NIST Development of Reference Material Scaffolds for Tissue Engineering

Content Provider	The American Society of Mechanical Engineers (ASME) Digital Collection
Author	Joy, P. Dunkers Stefan, D. Leigh Marcus, T. Cicerone Forrest, A. Landis Francis, W. Wang John, A. Tesk
Abstract	In consultation with ASTM and other stakeholders in Tissue-Engineered Medical Products (TEMPs) industry, the National Institute of Standards and Technology (NIST) initiated a project designed to produce Reference Material scaffolds for tissue engineering. The rationale for Reference Material scaffolds was developed through several NIST/Industry workshops. In brief, Reference Material scaffolds have multiple uses: facilitating the development and the validation of new test methods that measure interactions among various components of a TEMP; comparison with other scaffolds and scaffold materials in terms of cellular responses, biodegradation, and releases of growth factors; and comparisons of responses among various cell lines. The primary customers for Reference Material scaffolds are expected to be the TEMPs industry, academic researchers, regulators, and standards developing organizations. There are many properties of a TEMP that warrant development of multiple Reference Material scaffolds. Currently, NIST is defining a set of Reference Material scaffolds based on geometric descriptors such as permeability, pore volume, pore size distribution, interconnectivity, and tortuosity. In consultation with ASTM, NIST is testing three candidate scaffolds produced by: three dimensional (3-D) printing, stereolithography, and fused deposition modeling (FDM). Scaffolds made by these methods have been obtained from Mayo Clinic (Rochester, MN), Case Western Reserve University (CWRU) (Cleveland, OH), and Osteopore International (Singapore), respectively, for structural characterization. These prototype scaffolds, with well-defined architectures, have been selected to address the following items of interest: 1) establishment of useful functional definitions of porosity content, interconnectivity, and pores; 2) evaluation of testing methods listed in the Standard Guide for the Porosity of Polymeric Scaffolds for Use in Tissue-Engineered Medical Products, which is being drafted by ASTM. Currently, NIST and the Center for Devices and Radiological Health of the Food and Drug Administration, as well as other groups from US and foreign laboratories, are actively carrying out cross-validation test of these prototype scaffolds.
Sponsorship	Manufacturing Engineering Division and Materials Handling Division
Starting Page	207
Ending Page	212
Page Count	6
File Format	PDF
ISBN	0791842231
DOI	10.1115/IMECE2005-82012
e-ISBN	0791837696
Volume Number	Manufacturing Engineering and Materials Handling, Parts A and B
Conference Proceedings	ASME 2005 International Mechanical Engineering Congress and Exposition
Language	English
Publisher Date	2005-11-05
Publisher Place	Orlando, Florida, USA
Access Restriction	Subscribed
Subject Keyword	Biodegradation Printing Food and drug administration Tissue scaffolds Architecture Workshops (work spaces) Permeability Stereolithography Modeling Astm international National institute of standards and technology Tissue engineered devices Porosity Engineering prototypes Testing
Content Type	Text
Resource Type	Article

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