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European Parliament and Council Directive 2004/23/EC of 31 March 2004 on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells,
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European Parliament and Council Directive 2004/23/EC of 31 March 2004 on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells,
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6
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Multipotent Mesenchymal Stromal Stem Cell Expansion by Plating Whole Bone Marrow at a Low Cellular Density: A More Advantageous Method for Clinical Use
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Mareschi K, Rustichelli D, Calabrese R, Gunetti M, Sanavio F, Castiglia S, Risso A, Ferrero I, Fagioli F. Multipotent Mesenchymal Stromal Stem Cell Expansion by Plating Whole Bone Marrow at a Low Cellular Density: A More Advantageous Method for Clinical Use. Stem Cell International in press.
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Stem Cell International
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Soncin S, Lo Cicero V, Astori G, Soldati G, Gola M, Sürder D, Moccetti T. A practical approach for the validation of sterility, endotoxin and potency testing of bone marrow mononucleated cells used in cardiac regeneration in compliance with good manufacturing practice. J Transl Med 2009, 7:78. 10.1186/1479-5876-7-78, 2753319, 19737416.
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21
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84870694277
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Note
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European Parliament and Council Directive 2001/20/EC of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use,
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22
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84870705823
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Note
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Legislative decree N. 211/2003. Adoption of EC Directive 2001/20/EC related to the application of the good clinical practice in the execution of the clinical experimentations of medicines for clinical use,
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23
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84870723351
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Note
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European Parliament and Council Directive 2005/28/EC of 8 April 2005 laying down principles and detailed guidelines for good clinical practice as regards investigational medicinal products for human use, as well as the requirements for authorisation of the manufacturing or importation of such products,
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24
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84870662343
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Note
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Legislative Decree N. 200/2007, Application of European Commission Directive 2005/28/EC of 8 April 2005 laying down the principles and detailed guidelines for good clinical practice concerning investigational medicinal products for human use, as well as the requirements for authorisation of the manufacturing or importation of such products.
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25
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84870663030
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Note
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Italian Minister of Health Decree dated 21st December 2007 on the procedure to follow for the authorization to the competent authority, for the communication of substantial amendments and the declaration of conclusion of the clinical trial and for the application to seem to the ethical committee,
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