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Exploring Sources of Variability Related to the Clinical Translation of Regenerative Engineering Products:Proceedings of a Workshop (2019)
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Exploring Sources of Variability Related to the Clinical Translation of Regenerative Engineering Products
Proceedings of a Workshop(2019)
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Proceedings: Proceedings published by the National Academies of Sciences, Engineering, and Medicine chronicle the presentations and discussions at a workshop, symposium, or other event convened by the National Academies. The statements and opinions contained in proceedings are those of the participants and are not endorsed by other participants, the planning committee, or the National Academies.
National Academies of Sciences, Engineering, and Medicine; Health and Medicine Division; Board on Health Sciences Policy; Forum on Regenerative Medicine; Meredith Hackmann, Theresa Wizemann, and Sarah H. Beachy, Rapporteurs
The emerging multidisciplinary field of regenerative engineering is devoted to the repair, regeneration, and replacement of damaged tissues or organs in the body. To accomplish this it uses a combination of principles and technologies from disciplines such as advanced materials science, developmental and stem cell biology, immunology, physics, and clinical translation. The term "regenerative engineering" reflects a new understanding of the use of tissue engineering for regeneration and also the growing number of research and product development efforts that incorporate elements from a variety of fields. Because regenerative engineered therapies rely on live cells and scaffolds, there are inherent challenges in quality control arising from variability in source and final products. Furthermore, each patient recipient, tissue donor, and product application is unique, meaning that the field faces complexities in the development of safe and effective new products and therapies which are not faced by developers of more conventional therapies. Understanding the many sources of variability can help reduce this variability and ensure consistent results.
The Forum on Regenerative Medicine hosted a public workshop on October 18, 2018, in Washington, DC, to explore the various factors that must be taken into account in order to develop successful regenerative engineering products. Invited speakers and participants discussed factors and sources of variability in the development and clinical application of regenerative engineering products, characteristics of high-quality products, and how different clinical needs, models, and contexts can inform the development of a product to improve patient outcomes. This publication summarizes the presentation and discussion of the workshop.
Health and Medicine —Medical Technologies and Treatments
Health and Medicine —Health Sciences
Health and Medicine —Policy, Reviews and Evaluations
National Academies of Sciences, Engineering, and Medicine. 2019. Exploring Sources of Variability Related to the Clinical Translation of Regenerative Engineering Products: Proceedings of a Workshop. Washington, DC: The National Academies Press.https://doi.org/10.17226/25371.
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132 pages |6 x 9
Paperback: 978-0-309-48909-6
Ebook: 978-0-309-48912-6
DOI: https://doi.org/10.17226/25371
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skim chapter
Front Matter i-xx
1 Introduction and Overview 1-8
2 Sources of Variability Associated with Regenerative Therapies: Lessons from Case Studies 9-22
3 Factors Contributing to Patient Variability 23-40
4 Addressing Variability in Donor Tissues and Cells 41-56
5 Addressing Variability and Meeting Quality Expectations in the Manufacturing Setting 57-70
6 Exploring Variability and Its Impact on Product Regulation and Outcomes 71-78
7 Potential Next Steps to Consider for Addressing Variability 79-84
References 85-88
Appendix A: Workshop Agenda 89-94
Appendix B: Speaker Biographical Sketches 95-104
Appendix C: Statement of Task 105-106
Appendix D: Registered Attendees 107-112
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