Artículos científicos de interés regulatorio sobre terapias avanzadas

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Última actualización: 04/09/2013


  • 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. Risk of tumorigenicity in mesenchymal stromal cell-based therapies-Bridging scientific observations and regulatory viewpoints. Cytotherapy (2013) 15:753-759.
  • Bianco P, Barker R, Brüstle O, Cattaneo E, Clevers H, Daley GQ, De Luca M, Goldstein L, Lindvall O, Mummery C, Robey PG, Sattler de Sousa E Brito C, Smith A. Regulation of stem cell therapies under attack in Europe: for whom the bell tolls. EMBO J. (2013) 32:1489-1495.
  • Xu X, Liu Y, Cui Z, Wei Y, Zhang L. Effects of osmotic and cold shock on adherent human mesenchymal stem cells during cryopreservation. J. Biotechnol (2012) 162:224-231.
  • Lalu MM, McIntyre L, Pugliese C, Fergusson D, Winston BW, Marshall JC, Granton J, Stewart DJ; Canadian Critical Care Trials Group. Safety of cell therapy with mesenchymal stromal cells (SafeCell): a systematic review and meta-analysis of clinical trials. PLoS One (2012) 7:e47559.
  • Bronzini I, Patruno M, Iacopetti I, Martinello T. Influence of temperature, time and different media on mesenchymal stromal cells shipped for clinical application. Vet. J.(2012)194:121-123.
  • van der Loo JCM, Swaney WP, Grassman E, Terwilliger A, Higashimoto T, Schambach A, Hacein-Bey-Abina S, Nordling DL, Cavazzana-Calvo M, Thrasher A, Williams DA, Reeves L, Malik P. Critical Variables affecting clinical-grade production of the self-inactivating gamma-retroviral vector for the treatment of X-linked severe combined immunodeficiency. Gene Ther. (2012) 19:872–876.
  • van der Loo JCM, Swaney WP, Grassman E, Terwilliger A, Higashimoto T, Schambach A, Baum C, Thrasher AJ, Williams DA, Nordling DL, Reeves L, Malik P. Scale-up and manufacturing of clinical-grade self-inactivating γ-retroviral vectors by transient transfection. Gene Ther. (2012) 19:246-254.
  • Maciulaitis R, D’Apote L, Buchanan A, Pioppo L, Schneider CK. Clinical development of advanced therapy medicinal products in Europe: evidence that regulators must be proactive. Mol. Ther. (2012) 20:479-482.
  • François M, Copland IB, Yuan S, Romieu-Mourez R, Waller EK, Galipeau J. Cryopreserved mesenchymal stromal cells display impaired immunosuppressive properties as a result of heat-shock response and impaired interferon-γ licensing. Cytotherapy (2012) 14:147-52.
  • Sensebé L, Tarte K, Galipeau J, Krampera M, Martin I, Phinney DG, Shi Y; MSC Committee of the International Society for Cellular Therapy. Limited acquisition of chromosomal aberrations in human adult mesenchymal stromal cells.
    Ben-David U, Mayshar Y, Benvenisty N. Significant Acquisition of Chromosomal Aberrations in Human Adult Mesenchymal Stem Cells: Response to Sensebé et al. Cell Stem Cell.(2012) 10(1):9-10 y 10-11.
  • Pang WW, Price EA, Sahoo D, Beerman I, Maloney WJ, Rossi DJ, Schrier SL, Weissman IL. Human bone marrow hematopoietic stem cells are increased in frequency and myeloid-biased with age. Proc Natl Acad Sci USA(2011) 108:20012-7.
  • Baum C, Modlich U, Göhring G, Schlegelberger B. Concise review: managing genotoxicity in the therapeutic modification of stem cells. Stem Cells.(2011) 29:1479-84.
  • Grigoriadis N, Lourbopoulos A, Lagoudaki R, Frischer JM, Polyzoidou E, Touloumi O, Simeonidou C, Deretzi G, Kountouras J, Spandou E, Kotta K, Karkavelas G, Tascos N, Lassmann H. Variable behavior and complications of autologous bone marrow mesenchymal stem cells transplanted in experimental autoimmune encephalomyelitis. Exp Neurol.(2011) 230:78-89.
  • Torsvik A, Røsland GV, Svendsen A, Molven A, Immervoll H, McCormack E, Lønning PE, Primon M, Sobala E, Tonn JC, Goldbrunner R, Schichor C, Mysliwietz J, Lah TT, Motaln H, Knappskog S, Bjerkvig R. Spontaneous malignant transformation of human mesenchymal stem cells reflects cross-contamination: putting the research field on track – letter. Cancer Res.(2010) 70:6393-6.
  • Garcia S, Bernad A, Martín MC, Cigudosa JC, Garcia-Castro J, de la Fuente R. Pitfalls in spontaneous in vitro transformation of human mesenchymal stem cells. Exp Cell Res.(2010) 316:1648-50.
  • Nyberg-Hoffman C, Aguilar-Cordova E. Instability of adenoviral vectors during transport and its implication for clinical studies. Nat. Med. (1999) 5:955-957.