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For: 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)., CAT Scientific Secretariat. Challenges with advanced therapy medicinal products and how to meet them. Nat Rev Drug Discov 2010;9:195-201. [PMID: 20190786 DOI: 10.1038/nrd3052] [Cited by in Crossref: 134] [Cited by in F6Publishing: 109] [Article Influence: 12.2] [Reference Citation Analysis]
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3 Kooijman M, van Meer P, Gispen-de Wied C, Moors E, Hekkert M, Schellekens H. The risk-based approach to ATMP development – Generally accepted by regulators but infrequently used by companies. Regulatory Toxicology and Pharmacology 2013;67:221-5. [DOI: 10.1016/j.yrtph.2013.07.014] [Cited by in Crossref: 8] [Cited by in F6Publishing: 6] [Article Influence: 1.0] [Reference Citation Analysis]
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6 Versteegden LRM, de Jonge PKJD, IntHout J, van Kuppevelt TH, Oosterwijk E, Feitz WFJ, de Vries RBM, Daamen WF. Tissue Engineering of the Urethra: A Systematic Review and Meta-analysis of Preclinical and Clinical Studies. Eur Urol 2017;72:594-606. [PMID: 28385451 DOI: 10.1016/j.eururo.2017.03.026] [Cited by in Crossref: 46] [Cited by in F6Publishing: 29] [Article Influence: 11.5] [Reference Citation Analysis]
7 Ducret M, Fabre H, Degoul O, Atzeni G, McGuckin C, Forraz N, Alliot-Licht B, Mallein-Gerin F, Perrier-Groult E, Farges JC. Manufacturing of dental pulp cell-based products from human third molars: current strategies and future investigations. Front Physiol 2015;6:213. [PMID: 26300779 DOI: 10.3389/fphys.2015.00213] [Cited by in Crossref: 20] [Cited by in F6Publishing: 13] [Article Influence: 3.3] [Reference Citation Analysis]
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9 Johnson S, Atala A. Regenology: Time for a New Specialty? Stem Cells Transl Med 2019;8:4-6. [PMID: 30414265 DOI: 10.1002/sctm.18-0101] [Cited by in Crossref: 2] [Cited by in F6Publishing: 2] [Article Influence: 0.7] [Reference Citation Analysis]
10 Pacini S. Deterministic and stochastic approaches in the clinical application of mesenchymal stromal cells (MSCs). Front Cell Dev Biol 2014;2:50. [PMID: 25364757 DOI: 10.3389/fcell.2014.00050] [Cited by in Crossref: 30] [Cited by in F6Publishing: 32] [Article Influence: 4.3] [Reference Citation Analysis]
11 Cohen-haguenauer O. A Comprehensive Resource on EU Regulatory Information for Investigators in Gene Therapy Clinical Research and Advanced Therapy Medicinal Products. Human Gene Therapy 2013;24:12-8. [DOI: 10.1089/hum.2012.2525] [Cited by in Crossref: 7] [Cited by in F6Publishing: 2] [Article Influence: 0.9] [Reference Citation Analysis]
12 Lloyd-Williams H, Hughes DA. A systematic review of economic evaluations of advanced therapy medicinal products. Br J Clin Pharmacol 2021;87:2428-43. [PMID: 32154598 DOI: 10.1111/bcp.14275] [Cited by in Crossref: 10] [Cited by in F6Publishing: 7] [Article Influence: 10.0] [Reference Citation Analysis]
13 Carvalho M, Sepodes B, Martins AP. Regulatory and Scientific Advancements in Gene Therapy: State-of-the-Art of Clinical Applications and of the Supporting European Regulatory Framework. Front Med (Lausanne) 2017;4:182. [PMID: 29124055 DOI: 10.3389/fmed.2017.00182] [Cited by in Crossref: 23] [Cited by in F6Publishing: 15] [Article Influence: 5.8] [Reference Citation Analysis]
14 Apaydin EA, Richardson AS, Baxi S, Vockley J, Akinniranye O, Ross R, Larkin J, Motala A, Azhar G, Hempel S. An evidence map of randomised controlled trials evaluating genetic therapies. BMJ Evid Based Med 2020:bmjebm-2020-111448. [PMID: 33172937 DOI: 10.1136/bmjebm-2020-111448] [Cited by in Crossref: 1] [Cited by in F6Publishing: 1] [Article Influence: 1.0] [Reference Citation Analysis]
15 Patrikoski M, Mannerström B, Miettinen S. Perspectives for Clinical Translation of Adipose Stromal/Stem Cells. Stem Cells Int 2019;2019:5858247. [PMID: 31191677 DOI: 10.1155/2019/5858247] [Cited by in Crossref: 38] [Cited by in F6Publishing: 30] [Article Influence: 19.0] [Reference Citation Analysis]
16 Kureshi AK, Drake RA, Daniels JT. Challenges in the development of a reference standard and potency assay for the clinical production of RAFT tissue equivalents for the cornea. Regenerative Medicine 2014;9:167-77. [DOI: 10.2217/rme.13.92] [Cited by in Crossref: 11] [Cited by in F6Publishing: 8] [Article Influence: 1.6] [Reference Citation Analysis]
17 Nagpal A, Juttner C, Hamilton-Bruce MA, Rolan P, Koblar SA. Stem cell therapy clinical research: A regulatory conundrum for academia. Adv Drug Deliv Rev. 2017;122:105-114. [PMID: 27760370 DOI: 10.1016/j.addr.2016.10.001] [Cited by in Crossref: 7] [Cited by in F6Publishing: 6] [Article Influence: 1.4] [Reference Citation Analysis]
18 Grau-Vorster M, Rodríguez L, Torrents-Zapata S, Vivas D, Codinach M, Blanco M, Oliver-Vila I, García-López J, Vives J. Levels of IL-17F and IL-33 correlate with HLA-DR activation in clinical-grade human bone marrow-derived multipotent mesenchymal stromal cell expansion cultures. Cytotherapy 2019;21:32-40. [PMID: 30447901 DOI: 10.1016/j.jcyt.2018.09.009] [Cited by in Crossref: 11] [Cited by in F6Publishing: 9] [Article Influence: 3.7] [Reference Citation Analysis]
19 Flory E, Reinhardt J. European regulatory tools for advanced therapy medicinal products. Transfus Med Hemother 2013;40:409-12. [PMID: 24474890 DOI: 10.1159/000356364] [Cited by in Crossref: 21] [Cited by in F6Publishing: 17] [Article Influence: 2.6] [Reference Citation Analysis]
20 Zscharnack M, Krause C, Aust G, Thümmler C, Peinemann F, Keller T, Smink JJ, Holland H, Somerson JS, Knauer J, Schulz RM, Lehmann J. Preclinical good laboratory practice-compliant safety study to evaluate biodistribution and tumorigenicity of a cartilage advanced therapy medicinal product (ATMP). J Transl Med 2015;13:160. [PMID: 25990108 DOI: 10.1186/s12967-015-0517-x] [Cited by in Crossref: 12] [Cited by in F6Publishing: 10] [Article Influence: 2.0] [Reference Citation Analysis]
21 Ancans J. Cell therapy medicinal product regulatory framework in Europe and its application for MSC-based therapy development. Front Immunol. 2012;3:253. [PMID: 22912639 DOI: 10.3389/fimmu.2012.00253] [Cited by in Crossref: 54] [Cited by in F6Publishing: 40] [Article Influence: 6.0] [Reference Citation Analysis]
22 von Tigerstrom B. New Regulatory Pathways for Stem Cell-Based Therapies: Comparison and Critique of Potential Models. In: Pham PV, Rosemann A, editors. Safety, Ethics and Regulations. Cham: Springer International Publishing; 2017. pp. 173-99. [DOI: 10.1007/978-3-319-59165-0_7] [Cited by in Crossref: 1] [Cited by in F6Publishing: 1] [Article Influence: 0.3] [Reference Citation Analysis]
23 Buljovčić Z. [European Marketing Authorisation: a long process. Experiences of small biotech companies with the ATMP regulation]. Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz 2011;54:831-8. [PMID: 21698536 DOI: 10.1007/s00103-011-1310-5] [Cited by in Crossref: 3] [Cited by in F6Publishing: 1] [Article Influence: 0.3] [Reference Citation Analysis]
24 Lambrechts T, Papantoniou I, Sonnaert M, Schrooten J, Aerts JM. Model-based cell number quantification using online single-oxygen sensor data for tissue engineering perfusion bioreactors. Biotechnol Bioeng 2014;111:1982-92. [PMID: 24771348 DOI: 10.1002/bit.25274] [Cited by in Crossref: 17] [Cited by in F6Publishing: 15] [Article Influence: 2.4] [Reference Citation Analysis]
25 Goula A, Gkioka V, Michalopoulos E, Katsimpoulas M, Noutsias M, Sarri EF, Stavropoulos C, Kostakis A. Advanced Therapy Medicinal Products Challenges and Perspectives in Regenerative Medicine. J Clin Med Res 2020;12:780-6. [PMID: 33447311 DOI: 10.14740/jocmr3964] [Cited by in Crossref: 1] [Cited by in F6Publishing: 1] [Article Influence: 1.0] [Reference Citation Analysis]
26 Mirabel C, Puente-Massaguer E, Del Mazo-Barbara A, Reyes B, Morton P, Gòdia F, Vives J. Stability enhancement of clinical grade multipotent mesenchymal stromal cell-based products. J Transl Med 2018;16:291. [PMID: 30355298 DOI: 10.1186/s12967-018-1659-4] [Cited by in Crossref: 10] [Cited by in F6Publishing: 8] [Article Influence: 3.3] [Reference Citation Analysis]
27 Kent A, King NM, Cohen-Haguenauer O. Toward a proportionate regulatory framework for gene transfer: a patient group-led initiative. Hum Gene Ther 2011;22:126-34. [PMID: 20942607 DOI: 10.1089/hum.2010.163] [Cited by in Crossref: 5] [Cited by in F6Publishing: 3] [Article Influence: 0.5] [Reference Citation Analysis]
28 Janke HP, de Jonge PK, Feitz WF, Oosterwijk E. Reconstruction Strategies of the Ureter and Urinary Diversion Using Tissue Engineering Approaches. Tissue Engineering Part B: Reviews 2019;25:237-48. [DOI: 10.1089/ten.teb.2018.0345] [Cited by in Crossref: 8] [Cited by in F6Publishing: 2] [Article Influence: 4.0] [Reference Citation Analysis]
29 Coppens DG, De Bruin ML, Leufkens HG, Hoekman J. Global Regulatory Differences for Gene- and Cell-Based Therapies: Consequences and Implications for Patient Access and Therapeutic Innovation. Clin Pharmacol Ther 2018;103:120-7. [DOI: 10.1002/cpt.894] [Cited by in Crossref: 17] [Cited by in F6Publishing: 11] [Article Influence: 4.3] [Reference Citation Analysis]
30 Vives J, Oliver-vila I, Pla A. Quality compliance in the shift from cell transplantation to cell therapy in non-pharma environments. Cytotherapy 2015;17:1009-14. [DOI: 10.1016/j.jcyt.2015.02.002] [Cited by in Crossref: 28] [Cited by in F6Publishing: 22] [Article Influence: 4.7] [Reference Citation Analysis]
31 Martin I, Ireland H, Baldomero H, Passweg J. The survey on cellular and engineered tissue therapies in Europe in 2012. Tissue Eng Part A 2015;21:1-13. [PMID: 25425342 DOI: 10.1089/ten.TEA.2014.0515] [Cited by in Crossref: 26] [Cited by in F6Publishing: 20] [Article Influence: 4.3] [Reference Citation Analysis]
32 Abou-El-Enein M, Bauer G, Reinke P, Renner M, Schneider CK. A roadmap toward clinical translation of genetically-modified stem cells for treatment of HIV. Trends Mol Med. 2014;20:632-642. [PMID: 25262540 DOI: 10.1016/j.molmed.2014.08.004] [Cited by in Crossref: 21] [Cited by in F6Publishing: 20] [Article Influence: 3.0] [Reference Citation Analysis]
33 Coppens DGM, de Wilde S, Guchelaar HJ, De Bruin ML, Leufkens HGM, Meij P, Hoekman J. A decade of marketing approval of gene and cell-based therapies in the United States, European Union and Japan: An evaluation of regulatory decision-making. Cytotherapy 2018;20:769-78. [PMID: 29730080 DOI: 10.1016/j.jcyt.2018.03.038] [Cited by in Crossref: 12] [Cited by in F6Publishing: 8] [Article Influence: 4.0] [Reference Citation Analysis]
34 Mehrian M, Lambrechts T, Papantoniou I, Geris L. Computational Modeling of Human Mesenchymal Stromal Cell Proliferation and Extra-Cellular Matrix Production in 3D Porous Scaffolds in a Perfusion Bioreactor: The Effect of Growth Factors. Front Bioeng Biotechnol 2020;8:376. [PMID: 32411692 DOI: 10.3389/fbioe.2020.00376] [Cited by in Crossref: 3] [Cited by in F6Publishing: 2] [Article Influence: 3.0] [Reference Citation Analysis]
35 Frost HK, Kodama A, Ekström P, Dahlin LB. G-CSF prevents caspase 3 activation in Schwann cells after sciatic nerve transection, but does not improve nerve regeneration. Neuroscience 2016;334:55-63. [PMID: 27497708 DOI: 10.1016/j.neuroscience.2016.07.045] [Cited by in Crossref: 6] [Cited by in F6Publishing: 5] [Article Influence: 1.2] [Reference Citation Analysis]
36 Farkas AM, Mariz S, Stoyanova-Beninska V, Celis P, Vamvakas S, Larsson K, Sepodes B. Advanced Therapy Medicinal Products for Rare Diseases: State of Play of Incentives Supporting Development in Europe. Front Med (Lausanne). 2017;4:53. [PMID: 28560211 DOI: 10.3389/fmed.2017.00053] [Cited by in Crossref: 15] [Cited by in F6Publishing: 14] [Article Influence: 3.8] [Reference Citation Analysis]
37 Corrigan-Curay J, Cohen-Haguenauer O, O'Reilly M, Ross SR, Fan H, Rosenberg N, Somia N, King N, Friedmann T, Dunbar C, Aiuti A, Naldini L, Baum C, von Kalle C, Kiem HP, Montini E, Bushman F, Sorrentino BP, Carrondo M, Malech H, Gahrton G, Shapiro R, Wolff L, Rosenthal E, Jambou R, Zaia J, Kohn DB. Challenges in vector and trial design using retroviral vectors for long-term gene correction in hematopoietic stem cell gene therapy. Mol Ther 2012;20:1084-94. [PMID: 22652996 DOI: 10.1038/mt.2012.93] [Cited by in Crossref: 39] [Cited by in F6Publishing: 26] [Article Influence: 4.3] [Reference Citation Analysis]
38 Montali M, Barachini S, Panvini FM, Carnicelli V, Fulceri F, Petrini I, Pacini S. Growth Factor Content in Human Sera Affects the Isolation of Mesangiogenic Progenitor Cells (MPCs) from Human Bone Marrow. Front Cell Dev Biol 2016;4:114. [PMID: 27800477 DOI: 10.3389/fcell.2016.00114] [Cited by in Crossref: 3] [Cited by in F6Publishing: 3] [Article Influence: 0.6] [Reference Citation Analysis]
39 Becker R, van Dongen GAMS. EATRIS, a Vision for Translational Research in Europe. J of Cardiovasc Trans Res 2011;4:231-7. [DOI: 10.1007/s12265-011-9260-8] [Cited by in Crossref: 7] [Cited by in F6Publishing: 3] [Article Influence: 0.7] [Reference Citation Analysis]
40 van Schalkwyk MCI, van der Stegen SJC, Bosshard-Carter L, Graves H, Papa S, Parente-Pereira AC, Farzaneh F, Fisher CD, Hope A, Adami A, Maher J. Development and Validation of a Good Manufacturing Process for IL-4-Driven Expansion of Chimeric Cytokine Receptor-Expressing CAR T-Cells. Cells 2021;10:1797. [PMID: 34359966 DOI: 10.3390/cells10071797] [Reference Citation Analysis]
41 Wilson SL, Sidney LE, Dunphy SE, Rose JB, Hopkinson A. Keeping an eye on decellularized corneas: a review of methods, characterization and applications. J Funct Biomater 2013;4:114-61. [PMID: 24956084 DOI: 10.3390/jfb4030114] [Cited by in Crossref: 44] [Cited by in F6Publishing: 39] [Article Influence: 5.5] [Reference Citation Analysis]
42 Pavlović N, Stanimirov B, Stojančević M, Paut-kusturica M, Stoimenova A, Goločorbin-kon S, Mikov M. An Insight on Differences in Availability and Reimbursement of Orphan Medicines Among Serbia, Bulgaria and Sweden. Biotechnology & Biotechnological Equipment 2014;26:3236-41. [DOI: 10.5504/bbeq.2012.0085] [Cited by in Crossref: 13] [Cited by in F6Publishing: 1] [Article Influence: 1.9] [Reference Citation Analysis]
43 Sonnaert M, Luyten FP, Schrooten J, Papantoniou I. Bioreactor-Based Online Recovery of Human Progenitor Cells with Uncompromised Regenerative Potential: A Bone Tissue Engineering Perspective. PLoS One 2015;10:e0136875. [PMID: 26313143 DOI: 10.1371/journal.pone.0136875] [Cited by in Crossref: 13] [Cited by in F6Publishing: 12] [Article Influence: 2.2] [Reference Citation Analysis]
44 Ramón-cueto A, Muñoz-quiles C. Clinical application of adult olfactory bulb ensheathing glia for nervous system repair. Experimental Neurology 2011;229:181-94. [DOI: 10.1016/j.expneurol.2010.10.001] [Cited by in Crossref: 27] [Cited by in F6Publishing: 21] [Article Influence: 2.7] [Reference Citation Analysis]
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53 Klug B, Celis P, Carr M, Reinhardt J. Regulatory Structures for Gene Therapy Medicinal Products in the European Union. Gene Transfer Vectors for Clinical Application. Elsevier; 2012. pp. 337-54. [DOI: 10.1016/b978-0-12-386509-0.00017-x] [Cited by in Crossref: 15] [Cited by in F6Publishing: 3] [Article Influence: 1.7] [Reference Citation Analysis]
54 Papantoniou I, Sonnaert M, Geris L, Luyten FP, Schrooten J, Kerckhofs G. Three-dimensional characterization of tissue-engineered constructs by contrast-enhanced nanofocus computed tomography. Tissue Eng Part C Methods 2014;20:177-87. [PMID: 23800097 DOI: 10.1089/ten.TEC.2013.0041] [Cited by in Crossref: 33] [Cited by in F6Publishing: 30] [Article Influence: 4.1] [Reference Citation Analysis]
55 Izeta A, Herrera C, Mata R, Astori G, Giordano R, Hernández C, Leyva L, Arias S, Oyonarte S, Carmona G, Cuende N. Cell-based product classification procedure: What can be done differently to improve decisions on borderline products? Cytotherapy 2016;18:809-15. [PMID: 27209278 DOI: 10.1016/j.jcyt.2016.03.292] [Cited by in Crossref: 9] [Cited by in F6Publishing: 5] [Article Influence: 1.8] [Reference Citation Analysis]
56 Van Wilder P. Advanced Therapy Medicinal Products and Exemptions to the Regulation 1394/2007: How Confident Can We be? An Exploratory Analysis. Front Pharmacol 2012;3:12. [PMID: 22347860 DOI: 10.3389/fphar.2012.00012] [Cited by in Crossref: 15] [Cited by in F6Publishing: 11] [Article Influence: 1.7] [Reference Citation Analysis]
57 McBlane JW. Preclinical safety testing for cell-based products using animals. Biologicals 2015;43:425-8. [PMID: 26026578 DOI: 10.1016/j.biologicals.2015.05.002] [Cited by in Crossref: 3] [Cited by in F6Publishing: 3] [Article Influence: 0.5] [Reference Citation Analysis]
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