| Current Regulations for the Production of Multipotent Mesenchymal Stromal Cells for Clinical Application. | |
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MedLine Citation:
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PMID: 21512645 Owner: NLM Status: Publisher |
Abstract/OtherAbstract:
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SUMMARY: In this review, the appropriate legislation on the expansion of multipotent mesenchymal stromal cells (MSCs) in Europe is described. The collection of cells and the manufacturing of MSCs are being regulated by European Directives (EUDs). Recently, the Regulation on Advanced Therapies Medicinal Products (ATMPs) is being published, which is of importance for the production of MSCs in Europe, and this legislation is not yet ready, but it is in its final stage. MSCs are currently being used in clinical trials, mostly in academic hospitals, for patients suffering from a wide variety of diseases. Companies (small and medium-sized enterprises) are becoming more and more involved in the production of MSCs for human use, and since marketing authorisation is the scope of the Regulation it was decided to install a Committee on Advanced Therapies (CAT) within European Medicines Agency (EMEA). This CAT will formulate a draft opinion on quality, safety and efficacy of ATMPs and will have an advisory and scientific role for the Committee for Medicinal Products for human use. The aim of this review is to outline the current legislation which is important for the manufacturing of MSCs. |
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Authors:
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Ineke C M Slaper-Cortenbach |
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Publication Detail:
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Type: JOURNAL ARTICLE Date: 2008-7-21 |
Journal Detail:
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Title: Transfusion medicine and hemotherapy : offizielles Organ der Deutschen Gesellschaft fur Transfusionsmedizin und Immunhamatologie Volume: 35 ISSN: 1660-3818 ISO Abbreviation: - Publication Date: 2008 |
Date Detail:
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Created Date: 2011-4-22 Completed Date: - Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 101176417 Medline TA: Transfus Med Hemother Country: - |
Other Details:
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Languages: ENG Pagination: 295-298 Citation Subset: - |
Affiliation:
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UMC Utrecht, Utrecht Center for Gene and Cell Therapy, Utrecht, the Netherlands. |
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From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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