Autorinnen und Autoren des Paul-Ehrlich-Instituts sind durch Fettdruck kenntlich gemacht. Wenn Online-Abstracts oder Volltexte zu den Publikationen verfügbar sind, so sind diese verlinkt.
Anliker B, Childs L, Rau J, Renner M, Schüle S, Schuessler-Lenz M, Sebe A (2022): Regulatory Considerations for Clinical Trial Applications with CRISPR-Based Medicinal Products.
CRISPR J 5: 364-376.
Online-Abstract
Sebe A, Anliker B, Rau J, Renner M (2020): Genetisch modifizierte regulatorische T-Zellen: Therapiekonzepte und ihr regulatorischer Rahmen.
Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz 63: 1403-1411.
Online-Abstract
Gabner S, Ertl R, Velde K, Renner M, Jenner F, Egerbacher M, Hlavaty J (2018): Cytokine-induced interleukin-1 receptor antagonist protein expression in genetically engineered equine mesenchymal stem cells for osteoarthritis treatment.
J Gene Med 20: e3021.
Online-Abstract
Krackhardt AM, Anliker B, Hildebrandt M, Bachmann M, Eichmüller SB, Nettelbeck DM, Renner M, Uharek L, Willimsky G, Schmitt M, Wels WS, Schüssler-Lenz M (2018): Clinical translation and regulatory aspects of CAR/TCR-based adoptive cell therapies-the German Cancer Consortium approach.
Cancer Immunol Immunother 67: 513-523.
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Abou-El-Enein M, Cathomen T, Ivics Z, June CH, Renner M, Schneider CK, Bauer G (2017): Human Genome Editing in the Clinic: New Challenges in Regulatory Benefit-Risk Assessment.
Cell Stem Cell 21: 427-430.
Online-Abstract
Hlavatý J, Tonar Z, Renner M, Panitz S, Petznek H, Schweizer M, Schüle S, Kloke BP, Moldzio R, Witter K (2017): Tropism, intracerebral distribution, and transduction efficiency of HIV- and SIV-based lentiviral vectors after injection into the mouse brain: a qualitative and quantitative in vivo study.
Histochem Cell Biol 148: 313-329.
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Gabner S, Hlavaty J, Velde K, Renner M, Jenner F, Egerbacher M (2016): Inflammation-induced transgene expression in genetically engineered equine mesenchymal stem cells.
J Gene Med 18: 154-164.
Online-Abstract
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 (2016): Report of the International Regulatory Forum on Human Cell Therapy and Gene Therapy Products.
Biologicals 44: 467-479.
Online-Abstract
Renner M, Anliker B, Flory E, Scherer J, Schüßler-Lenz M, Schweizer M, Ivics Z: Regulation for Gene and Cell Therapy Medicinal Products in Europe.
In: Terai S, Suda T (Hrsg.), Gene Therapy and Cell Therapy Through the Liver. Tokyo: Springer, 2016. S. 105-123, ISBN 978-4-431-55665-7
Anliker B, Renner M, Schweizer M (2015): Genetisch modifizierte Zellen zur Therapie verschiedener Erkrankungen.
Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz 58: 1274-1280.
Online-Abstract
Renner M, Anliker B, Sanzenbacher R, Schuele S (2015): Regulation of Clinical Trials with Advanced Therapy Medicinal Products in Germany.
Adv Exp Med Biol 871: 87-101.
Online-Abstract
Renner M (2015): Cell therapy clinical trials in Germany - Critical aspects of quality data content: Summary of meeting presentation..
Biologicals 43: 429-432.
Online-Abstract
Salmikangas P, Schuessler-Lenz M, Ruiz S, Celis P, Reischl I, Menezes-Ferreira M, Flory E, Renner M, Ferry N (2015): Marketing Regulatory Oversight of Advanced Therapy Medicinal Products (ATMPs) in Europe: The EMA/CAT Perspective.
Adv Exp Med Biol 871: 103-130.
Online-Abstract
Wuchter P, Bieback K, Schrezenmeier H, Bornhäuser M, Müller LP, Bönig H, Wagner W, Meisel R, Pavel P, Tonn T, Lang P, Müller I, Renner M, Malcherek G, Saffrich R, Buss EC, Horn P, Rojewski M, Schmitt A, Ho AD, Sanzenbacher R, Schmitt M (2015): Standardization of Good Manufacturing Practice-compliant production of bone marrow-derived human mesenchymal stromal cells for immunotherapeutic applications.
Cytotherapy 17: 128-139.
Online-Abstract
Abou-El-Enein M, Bauer G, Reinke P, Renner M, Schneider CK (2014): A roadmap toward clinical translation of genetically-modified stem cells for treatment of HIV.
Trends Mol Med 20: 632-642.
Online-Abstract
Wuchter P, Bieback K, Schrezenmeier H, Bornhäuser M, Müller LP, Bönig H, Wagner W, Meisel R, Pavel P, Tonn T, Lang P, Müller I, Renner M, Malcherek G, Saffrich R, Buss EC, Horn P, Rojewski M, Schmitt A, Ho AD, Sanzenbacher R, Schmitt M (2014): Standardization of Good Manufacturing Practice-compliant production of bone marrow-derived human mesenchymal stromal cells for immunotherapeutic applications.
Cytotherapy 17: 128-139.
Online-Abstract
Aiuti A, Cossu G, de Felipe P, Galli MC, Narayanan G, Renner M, Stahlbom A, Schneider CK, Voltz-Girolt C (2013): The committee for advanced therapies' of the European Medicines Agency reflection paper on management of clinical risks deriving from insertional mutagenesis.
Hum Gene Ther Clin Dev 24: 47-54.
Online-Abstract
Langer B, Renner M, Scherer J, Schüle S, Cichutek K (2013): Safety assessment of biolistic DNA vaccination.
Methods Mol Biol 940: 371-388.
Online-Abstract
Anliker B, Renner M, Schweizer M (2012): Insertionsonkogenese bei der Gentherapie monogenetischer Erbkrankheiten.
Bulletin zur Arzneimittelsicherheit 3: 22-26.
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Hlavaty J, Petznek H, Holzmüller H, Url A, Jandl G, Berger A, Salmons B, Günzburg WH, Renner M (2012): Evaluation of a gene-directed enzyme-product therapy (GDEPT) in human pancreatic tumor cells and their use as in vivo models for pancreatic cancer.
PLoS One 7: e40611.
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Hlavaty J, Jandl G, Liszt M, Petznek H, König-Schuster M, Sedlak J, Egerbacher M, Weissenberger J, Salmons B, Günzburg WH, Renner M (2011): Comparative evaluation of preclinical in vivo models for the assessment of replicating retroviral vectors for the treatment of glioblastoma.
J Neurooncol 102: 59-69.
Online-Abstract
Schüle S, Renner M, Longhurst S, Narayanan G (2010): Regulatory requirements for clinical trial and marketing authorisation application for gene therapy medicinal products.
Bundesgesundheitsbl – Gesundheitsforsch – Gesundheitsschutz 53: 30-37.
Online-Abstract
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