What Is the Greatest Regulatory Challenge in the Translation of Biomaterials to the Clinic?
Abstract
Leaders in the field comment on what they perceive to be the greatest barriers to biomaterial translation.
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Combining cells with biomaterials can assist cells to remain and develop in specific sites, usually for regenerative purposes.
“Further complications for outcomes can arise when combining cells with biomaterials, which can assist cells to remain and develop in specific sites, usually for regenerative purposes88.”
From How to design preclinical studies in nanomedicine and cell therapy to maximize the prospects of clinical translation (2018) · cites this paper as [88]
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- Authors
- Prestwich, G. D., Bhatia, S., Breuer, C. K., Dahl, S. L. M., Mason, C., McFarland, R., McQuillan, D. J., Sackner-Bernstein, J., Schox, J., Tente, W. E., & Trounson, A.
- Affiliations
- University of Utah (US)
- Massachusetts Institute of Technology (US)
- Nationwide Children's Hospital (US)
- Humacyte (United States) (US)
- University College London (GB)
- Center for Biologics Evaluation and Research (US)
- Neostem, New York, NY 10170, USA.
- Schox PLC, San Francisco, CA 94107, USA.
- California Institute for Regenerative Medicine (US)
- Corresponding author
- Prestwich, Glenn D.
- Venue
- Science Translational Medicine
- Published
- 2012-11-14
- Volume
- 4
- Issue
- 160
- Pages
- 160cm14-160cm14
- ISSN
- 1946-6234 (ISSN-L)
- 1946-6242
- OpenAlex
- W2118265453
- Cited by
- 63
- References
- 0
- Citations by year
- 2026: 3 · 2025: 4 · 2024: 1 · 2023: 1 · 2022: 5 · 2021: 3 · 2020: 3 · 2019: 8 · 2018: 3 · 2017: 5 · 2016: 9 · 2015: 6 · 2014: 5 · 2013: 5 · 2012: 2
- FWCI
- 3.86
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Science Translational Medicine (publishedVersion)
- PubMed (publishedVersion)
- UCL Discovery (University College London) (submittedVersion)
- Topics
- Health Sciences › Medicine › Physiology › Biomedical Ethics and Regulation
- Health Sciences › Medicine › Surgery › Tissue Engineering and Regenerative Medicine
- Health Sciences › Health Professions › Health Information Management › Healthcare Regulation
- Keywords
- biomaterials, clinical translation, regulatory challenges, translational barriers, medical device regulation
- MeSH terms
- Animals, Biocompatible Materials, Biotechnology, Humans, United States, United States Food and Drug Administration, Tissue Engineering, Translational Research, Biomedical
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