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008 190902s2019 dcua obt 100 0 eng
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020 _a9780309489096
020 _a9780309489102
_q((electronic)l(electronic)ctronic)
020 _a9780309489126
_q((electronic)l(electronic)ctronic)
042 _apcc
043 _an-us---
050 0 4 _aQH499
_b.E975 2019
049 _aMAIN
100 1 _aHackmann, Meredith,
_e1
245 1 0 _aExploring sources of variability related to the clinical translation of regenerative engineering products :
_bproceedings of a workshop /
_cMeredith Hackmann, Theresa Wizemann, and Sarah H. Beachy, rapporteurs ; Forum on Regenerative Medicine, Board on Health Sciences Policy, National Academies of Sciences, Engineering, Medicine.
260 _aWashington, DC :
_bNational Academies Press,
_c(c)2019.
300 _a1 online resource (1 PDF file (xx, 111 pages)) :
_billustration
336 _atext
_btxt
_2rdacontent
337 _acomputer
_bc
_2rdamedia
338 _aonline resource
_bcr
_2rdacarrier
347 _adata file
_2rda
490 1 _aA consensus study report of the National Academies of Sciences, Engineering, Medicine
504 _a1
520 3 _aThe 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.
530 _a2
_ub
536 _aThis activity was supported by contracts between the National Academy of Sciences and Advanced Regenerative Manufacturing Institute (unnumbered contract); Akron Biotech (unnumbered contract); Alliance for Regenerative Medicine (unnumbered contract); ALS Association (unnumbered contract); American Society of Gene and Cell Therapy (unnumbered contract); Burroughs Wellcome Fund (unnumbered contract); California Institute for Regenerative Medicine (unnumbered contract); Centre for Commercialization of Regenerative Medicine (unnumbered contract); Department of Veterans Affairs (Contract No. VA268-16-C-0051); Food and Drug Administration (Grant #1R13FD0066--14-01); GE Healthcare (unnumbered contract); GlaxoSmithKline (unnumbered contract); International Society for Cellular Therapy (unnumbered contract); International Society for Stem Cell Research (unnumbered contract); Johnson and Johnson (unnumbered contract); Juno Therapeutics (unnumbered contract); The Michael J. Fox Foundation for Parkinson's Research (unnumbered contract); National Institute of Standards and Technology (unnumbered contract); National Institutes of Health (Contract No. HHSN263201200074I, Order No. HHSN23600075: National Heart, Lung, and Blood Institute; National Institute of Arthritis and Musculoskeletal and Skin Diseases; National Institute of Biomedical Imaging and Bioengineering; National Institute of Dental and Craniofacial Research; National Institute of Diabetes and Digestive and Kidney Diseases; and National Institute of Neurological Disorders and Stroke); The New York Stem Cell Foundation (unnumbered contract); Parkinson's Foundation (unnumbered contract); Takeda Development Center Americas (unnumbered contract); and United Therapeutics Corporation (#10003921). Any opinions, conclusions, or recommendations expressed in this publication do not necessarily reflect the views of any organization or agency that provided support for the project.
505 0 0 _aIntroduction and overview --
_tSources of variability associated with regenerative therapies : lessons from case studies --
_tFactors contributing to patient variability --
_tAddressing variability in donor tissues and cells --
_tAddressing variability and meeting quality expectations in the manufacturing setting --
_tExploring variability and its impact on product regulation and outcomes --
_tPotential next steps to consider for addressing variability --
_tReferences --
_tAppendixes
650 0 _aRegenerative medicine
_vCongresses.
650 0 _aRegenerative medicine
_xStandards
_vCongresses.
650 0 _aQuality control
_vCongresses.
650 0 _aTissue engineering.
650 0 _aQuality control.
650 1 2 _aTissue Engineering
_xstandards
650 1 2 _aRegenerative Medicine
_xstandards
650 2 2 _aQuality Control
650 2 2 _aTranslational Research, Biomedical
655 1 _aElectronic Books.
700 1 _aNational Academies of Sciences, Engineering, and Medicine (U.S.).
_eissuing body.
700 1 _aWizemann, Theresa M.,
_erapporteur.
700 1 _aBeachy, Sarah H.,
_erapporteur.
711 2 _aExploring Sources of Variability Related to the Clinical Translation of Regenerative Engineering Products (Workshop)
_cWashington, D.C.)
856 4 0 _zClick to access digital title | log in using your CIU ID number and my.ciu.edu password.
_uhttpss://search.ebscohost.com/login.aspx?direct=true&scope=site&db=nlebk&db=nlabk&AN=2219053&site=eds-live&custid=s3260518
942 _cOB
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994 _a92
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999 _c78741
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902 _a1
_bCynthia Snell
_c1
_dCynthia Snell