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Tissue engineered medical products (TEMPs)

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Published by ASTM in West Conshohocken, PA .
Written in English

Subjects:

  • Tissue engineering -- Standards -- Congresses,
  • Medical protocols -- Congresses

Book details:

Edition Notes

StatementEliane Schutte, Grace L. Picciolo, and David Kaplan, editors.
GenreCongresses.
SeriesSTP -- 1452., ASTM special technical publication -- 1452.
ContributionsSchutte, Eliane, 1970-, Picciolo, Grace Lee., Kaplan, David S., 1957-
Classifications
LC ClassificationsR857.T55 S96 2002
The Physical Object
Paginationvi, 266 p. :
Number of Pages266
ID Numbers
Open LibraryOL18791964M
ISBN 100803134711
LC Control Number2004043760
OCLC/WorldCa54501473

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  Tissue-engineered product A medicine containing engineered cells or tissues, which is intended to regenerate, repair or replace a human tissue. For more information, see advanced ://   Reference Title Type; ISO/TC /SC 7/WG 1 Management of risk: Working group: ISO/TC /SC 7/WG 3 Tissue-engineered medical products for skeletal tissues   Human tissue engineered products may carry greater risks than most medical devices, and these risks are more difficult to assess. 7 Clinical introduction and the vigilance and surveillance systems for human implant technologies generally are of growing concern. 8 Developments in tissue engineered and regenerative medicine products summarizes recent developments in tissue engineering and regenerative medicine with an emphasis on commercialization and product development. Features of current cell therapy - Selection from Developments in Tissue Engineered and Regenerative Medicine Products [Book]

  Human cells or tissue intended for implantation, transplantation, infusion, or transfer into a human recipient is regulated as a human cell, tissue, and cellular and tissue-based product or HCT/:// Keywords: Tissue engineered medical products (TEMPs), bioethics, regulatory issues, Food and Drug Administration (FDA), medical devices, commercialization. Introduction: Bedside to Bench and Back Approach. The field of tissue engineering and regenerative medicine is rapidly expanding, both in laboratory research and in clinical translation 1 F Terminology Relating to Tissue Engineered Medical Products. F Guide for Assessing Microstructure of Polymeric Scaffolds for Use in Tissue-Engineered Medical Products. F Guide for Interpreting Images of Polymeric Tissue Scaffolds. F Guide for Assessment of Surface Texture of Non-Porous Biomaterials in Two Dimensions   Human tissue-engineered products (hTEPs) are expected to have a considerable impact on medical practice and to enhance patients’ quality of life by improving existing treatments and offering new treatments for currently incurable conditions. These products largely fall outside the scope of current European legislation. Approaches

Quality Control for TE Products—A Multiscale Approach. Tissue-engineered product characterization and analysis will be of higher complexity than for other biochemically derived biological products. Moreover, QC is of high importance due to potential manufacturing process variability and the living nature of the ://   cal devices for use in tissue engineered medical products or drug delivery devices for implantation as determined to be appropriate, based on supporting biocompatibility and physical test data. Recommendations in this guide should not be interpreted as a guarantee of clinical success in any tissue engineered medical product or drug delivery Fpdf. In tissue engineering, one usually needs to start from some biological material. It may be cells from an animal or a human being that are removed and, for example, placed on some matrix to grow into a structure. Most tissue-engineered structures are meant to eventually find their way into humans to be used as a treatment or :// This book covers all aspects of Vascular Tissue Engineering and novel alternatives to develop vascular grafts for clinical applications. The authors are key opinion leaders. Early clinical trials are periodically updated on results, regulatory aspects and post-marketing quality  › Life Sciences › Cell Biology.