TY - JOUR A1 - Astori, Giuseppe A1 - Amati, Eliana A1 - Bambi, Franco A1 - Bernardi, Martina A1 - Chieregato, Katia A1 - Schäfer, Richard A1 - Sella, Sabrina A1 - Rodeghiero, Francesco T1 - Platelet lysate as a substitute for animal serum for the ex-vivo expansion of mesenchymal stem/stromal cells : present and future T2 - Stem cell research & therapy N2 - The use of fetal bovine serum (FBS) as a cell culture supplement is discouraged by regulatory authorities to limit the risk of zoonoses and xenogeneic immune reactions in the transplanted host. Additionally, FBS production came under scrutiny due to animal welfare concerns. Platelet derivatives have been proposed as FBS substitutes for the ex-vivo expansion of mesenchymal stem/stromal cells (MSCs) since platelet-derived growth factors can promote MSC ex-vivo expansion. Platelet-derived growth factors are present in platelet lysate (PL) obtained after repeated freezing-thawing cycles of the platelet-rich plasma or by applying physiological stimuli such as thrombin or CaCl2.PL-expanded MSCs have been used already in the clinic, taking advantage of their faster proliferation compared with FBS-expanded preparations. Should PL be applied to other biopharmaceutical products, its demand is likely to increase dramatically. The use of fresh platelet units for the production of PL raises concerns due to limited availability of platelet donors. Expired units might represent an alternative, but further data are needed to define safety, including pathogen reduction, and functionality of the obtained PL. In addition, relevant questions concerning the definition of PL release criteria, including concentration ranges of specific growth factors in PL batches for various clinical indications, also need to be addressed. We are still far from a common definition of PL and standardized PL manufacture due to our limited knowledge of the mechanisms that mediate PL-promoting cell growth. Here, we concisely discuss aspects of PL as MSC culture supplement as a preliminary step towards an agreed definition of the required characteristics of PL for the requirements of manufacturers and users. KW - Platelet lysate KW - Platelet releasate KW - Mesenchymal stem/stromal cells KW - Fetal bovine serum KW - Pathogen reduction KW - Manufacturing Y1 - 2017 UR - http://publikationen.ub.uni-frankfurt.de/frontdoor/index/index/docId/43167 UR - https://nbn-resolving.org/urn:nbn:de:hebis:30:3-431675 SN - 1757-6512 N1 - Copyright: © The Author(s). 2016. Open Access: This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated. VL - 7 IS - 1, Art. 93 SP - 1 EP - 8 PB - BioMed Central CY - London ER -