Tissue engineering and regenerative medicine (TERM) hold great promise for treating diseases and reducing overall healthcare costs. Use of 3D tissue scaffolds as a template for regeneration is the basis of tissue engineering. There has been an increased recognition that the lack of standards and reference materials presents a major obstacle for the success of this industry. The Alliance for Regenerative Medicine, an advocacy organization for TERM, recently completed an industry report that concluded “product consistency and lack of standards is possibly the single greatest challenge facing the field” of TERM (“Pharma and Biotech Survey”, March 2014). Others, including regulatory agencies, have increased their effort to participate and discuss standards that can be developed for this complex field. The goal of this research program is to develop advanced measurement tools and standards for quantifying scaffold properties and their impact on biological response.
Programmatic Achievement and Impact
- Deployed 4 NIST Reference Materials (RM8394 - RM8397) for measuring porosity of and cell proliferation on scaffolds.
- Invented an airbrushing technology for rapid fabrication of fibrillar mats that may enable point-of-care spray-on 3D tissue scaffolds and wound dressings.
- Developed combinatorial cassettes as high-throughput, systematic in vivo testing platforms to increase measurement confidence and reduce the number of animals needed for testing (animal welfare).
- Developed 3D image analysis methods for quantitative descriptors of cell and scaffold shape metrics.
- Conducting the largest study of 3D stem cell morphology: 1500 z-stacks of stem cells, 1 TB of data, to determine the role of cell shape on biological response.
- Major research findings have been published (17 peer-reviewed papers since Oct 2012), 11 invited presentations have been delivered, and one patent application was filed.
The 3D scaffolds project has expertise in the areas of stem cell-material interactions, stem cells, scaffold fabrication, scaffold characterization, 3D imaging, bioinformatics and standard reference materials and documentary standards for tissue-engineered medical products, regenerative medicine and cell therapy products.
Customer Outreach and Technology/Knowledge Transfer
- Expertise frequently sought to advise on measurements of scaffold properties, measurement of cell-material interactions, the value of new scaffolding technologies, and development of standards for biological measurements.
- Regular interaction with industry, federal agencies, and academic labs to learn about customer measurement needs and to disseminate NIST measurements.
- The team holds leadership positions in relevant societies (Society for Biomaterials, TERMIS-AM, ASTM, ISO), frequently organizes meetings (1 workshop and 4 symposia), and serves on Editorial Boards of Biomaterials and Journal of Biomedical Materials Research – Applied Biomaterials.
- Since Oct 1, 2012, this program has mentored 8 NRC postdocs and 5 NIST associates.