| Cell-based treatments: advanced therapies and transplants. | |
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MedLine Citation:
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PMID: 21335218 Owner: NLM Status: In-Data-Review |
Abstract/OtherAbstract:
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The introduction of Regulation 1394/2007/EC managing the use of tissue engineering products for the purpose of repairing, regenerating, or replacing missing tissue and cells has created a gray area where transplant and medicinal products overlap. The classification of such borderline products depends on the European Medicines Agency at the moment of marketing application. However, when these products first enter into the clinical development, the burden of definition falls on National competent authorities. The concept of "minimal manipulation" and of "heterologous use" are introduced to describe currently used criteria. |
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Authors:
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R Botta; G Migliaccio |
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Publication Detail:
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Type: Journal Article |
Journal Detail:
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Title: Transplantation proceedings Volume: 43 ISSN: 1873-2623 ISO Abbreviation: Transplant. Proc. Publication Date: 2011 Jan-Feb |
Date Detail:
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Created Date: 2011-02-21 Completed Date: - Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 0243532 Medline TA: Transplant Proc Country: United States |
Other Details:
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Languages: eng Pagination: 338-40 Citation Subset: IM |
Copyright Information:
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Copyright © 2011 Elsevier Inc. All rights reserved. |
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From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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