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Master Thesis

Lysat plaquettaire, statuts juridiques et autorisations nécessaires à son utilisation en Europe

Abstract : Platelet lysate is a liquid product derived from human blood donations, particularly from platelet concentrates. Once collected, platelet concentrates undergo various manipulations leading to the lysis of the platelets and their contents. Certain steps in the manufacturing process are variable and thus make it possible to obtain different types of lysates: inactivated platelet lysate, 30% plasma platelet lysate, heparin-free platelet lysate, etc. The granules that make up the platelets contain numerous proteins, and in particular certain growth factors acting in cell proliferation. This is why platelet lysate is used today as a culture medium supplement in cell culture, replacing fetal calf serum. However, due to its rich content of active molecules, some studies are analyzing the potential interest of using platelet lysate in therapy. If such a use proves possible, the legal status of this product will have to be defined. Three possibilities are possible in therapeutics: will it become an active substance, a preparation for cell therapy or a drug? If the platelet lysate is a drug, it will be necessary to define to which subtype it belongs. Each legal status conditions the authorizations necessary for the use of the product in Europe. To date, knowledge does not allow a final decision on the case of platelet lysate and leaves open the discussion on its designation/use.
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Master Thesis
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https://dumas.ccsd.cnrs.fr/dumas-03162427
Contributor : Frédérique Gambade Connect in order to contact the contributor
Submitted on : Monday, March 8, 2021 - 2:55:32 PM
Last modification on : Thursday, April 15, 2021 - 3:11:41 AM
Long-term archiving on: : Wednesday, June 9, 2021 - 7:11:32 PM

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Marine Desgouillons. Lysat plaquettaire, statuts juridiques et autorisations nécessaires à son utilisation en Europe. Sciences du Vivant [q-bio]. 2021. ⟨dumas-03162427⟩

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