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Exploring sources of variability related to the clinical translation of regenerative engineering products [electronic resource] proceedings of a workshop
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| 자료유형 | 단행본 |
|---|---|
| 서명/저자사항 | Exploring sources of variability related to the clinical translation of regenerative engineering products : proceedings of a workshop/ Meredith Hackmann, Theresa Wizemann, and Sarah H. Beachy, rapporteurs ; Forum on Regenerative Medicine, Board on Health Sciences Policy, Health and Medicine Division, the National Academies of Sciences, Engineering, Medicine. [electronic resource]. |
| 개인저자 | Hackmann. Wizemann, Theresa M.,rapporteur, Beachy, Sarah H.,rapporteur, |
| 단체저자명 | National Academies of Sciences, Engineering, and Medicine (U.S.). Forum on Regenerative Medicine,issuing body. |
| 발행사항 | Washington, DC: the National Academies Press, [2019]. |
| 형태사항 | 1 online resource (xx,111 pages): color illustrations, Meredith,+ rapporteur. |
| 기타형태 저록 | Print version: 0309489091 9780309489096 |
| ISBN | 9780309489102 0309489105 9780309489126 0309489121 |
| 서지주기 | Includes bibliographical references (pages 85-88). |
| 내용주기 | Introduction and overview -- Sources of variability associated with regenerative therapies : lessons from case studies -- Factors contributing to patient variability -- Addressing variability in donor tissues and cells -- Addressing variability and meeting quality expectations in the manufacturing setting -- Exploring variability and its impact on product regulation and outcomes -- Potential next steps to consider for addressing variability -- References -- Appendixes |
| 요약 | "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"--Publisher's description |
| 회의명 | Exploring Sources of Variability Related to the Clinical Translation of Regenerative Engineering Products (Workshop) (2018 : Washington, D.C.), |
| 일반주제명 | Regenerative medicine --Congresses. Regenerative medicine --Standards --Congresses. Quality control --Congresses. Tissue engineering. |
| 언어 | 영어 |
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