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Risk of tumorigenicity in mesenchymal stromal cell-based therapies--bridging scientific observations and regulatory viewpoints.
Barkholt L, Flory E, Jekerle V, Lucas-Samuel S, Ahnert P, Bisset L, Büscher D, Fibbe W, Foussat A, Kwa M, Lantz O, Mačiulaitis R, Palomäki T, Schneider CK, Sensebé L, Tachdjian G, Tarte K, Tosca L, Salmikangas P. Barkholt L, et al. Among authors: salmikangas p. Cytotherapy. 2013 Jul;15(7):753-9. doi: 10.1016/j.jcyt.2013.03.005. Epub 2013 Apr 18. Cytotherapy. 2013. PMID: 23602595 Review.
Cell-based therapies for cardiac repair: a meeting report on scientific observations and European regulatory viewpoints.
Schüssler-Lenz M, Beuneu C, Menezes-Ferreira M, Jekerle V, Bartunek J, Chamuleau S, Celis P, Doevendans P, O'Donovan M, Hill J, Hystad M, Jovinge S, Kyselovič J, Lipnik-Stangelj M, Maciulaitis R, Prasad K, Samuel A, Tenhunen O, Tonn T, Rosano G, Zeiher A, Salmikangas P. Schüssler-Lenz M, et al. Among authors: salmikangas p. Eur J Heart Fail. 2016 Feb;18(2):133-41. doi: 10.1002/ejhf.422. Epub 2015 Oct 16. Eur J Heart Fail. 2016. PMID: 26470631 Free article.
Advanced Therapy Medicinal Products: How to Bring Cell-Based Medicinal Products Successfully to the Market - Report from the CAT-DGTI-GSCN Workshop at the DGTI Annual Meeting 2014.
Celis P, Ferry N, Hystad M, Schüßler-Lenz M, Doevendans PA, Flory E, Beuneu C, Reischl I, Salmikangas P. Celis P, et al. Among authors: salmikangas p. Transfus Med Hemother. 2015 May;42(3):194-9. doi: 10.1159/000382107. Epub 2015 Apr 28. Transfus Med Hemother. 2015. PMID: 26195933 Free PMC article.
Challenges with advanced therapy medicinal products and how to meet them.
Committee for Advanced Therapies (CAT); CAT Scientific Secretariat; Schneider CK, Salmikangas P, Jilma B, Flamion B, Todorova LR, Paphitou A, Haunerova I, Maimets T, Trouvin JH, Flory E, Tsiftsoglou A, Sarkadi B, Gudmundsson K, O'Donovan M, Migliaccio G, Ancāns J, Maciulaitis R, Robert JL, Samuel A, Ovelgönne JH, Hystad M, Fal AM, Lima BS, Moraru AS, Turcáni P, Zorec R, Ruiz S, Akerblom L, Narayanan G, Kent A, Bignami F, Dickson JG, Niederwieser D, Figuerola-Santos MA, Reischl IG, Beuneu C, Georgiev R, Vassiliou M, Pychova A, Clausen M, Methuen T, Lucas S, Schüssler-Lenz M, Kokkas V, Buzás Z, MacAleenan N, Galli MC, Linē A, Gulbinovic J, Berchem G, Fraczek M, Menezes-Ferreira M, Vilceanu N, Hrubisko M, Marinko P, Timón M, Cheng W, Crosbie GA, Meade N, di Paola ML, VandenDriessche T, Ljungman P, D'Apote L, Oliver-Diaz O, Büttel I, Celis P. Committee for Advanced Therapies (CAT), et al. Among authors: salmikangas p. Nat Rev Drug Discov. 2010 Mar;9(3):195-201. doi: 10.1038/nrd3052. Nat Rev Drug Discov. 2010. PMID: 20190786 Review.
Report of the International Regulatory Forum on Human Cell Therapy and Gene Therapy Products.
Hayakawa T, Harris I, Joung J, Kanai N, Kawamata S, Kellathur S, Koga J, Lin YC, Maruyama Y, McBlane J, Nishimura T, Renner M, Ridgway A, Salmikangas P, Sakamoto N, Sato D, Sato Y, Toda Y, Umezawa A, Werner M, Wicks S. Hayakawa T, et al. Among authors: salmikangas p. Biologicals. 2016 Sep;44(5):467-79. doi: 10.1016/j.biologicals.2016.06.002. Epub 2016 Jul 22. Biologicals. 2016. PMID: 27461129
Clinical Development and Commercialization of Advanced Therapy Medicinal Products in the European Union: How Are the Product Pipeline and Regulatory Framework Evolving?
Boráň T, Menezes-Ferreira M, Reischl I, Celis P, Ferry N, Gänsbacher B, Krafft H, Lipucci di Paola M, Sladowski D, Salmikangas P. Boráň T, et al. Among authors: salmikangas p. Hum Gene Ther Clin Dev. 2017 Sep;28(3):126-135. doi: 10.1089/humc.2016.193. Epub 2017 May 16. Hum Gene Ther Clin Dev. 2017. PMID: 28510497 Review.
28 results