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Cell Therapy Regulations from a European Perspective

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Regenerative Therapy Using Blood-Derived Stem Cells

Part of the book series: Stem Cell Biology and Regenerative Medicine ((STEMCELL))

Abstract

This chapter provides an overview of the current status of cell therapy regulation in Europe. This includes the description of GMP standards and other significant regulations for quality assurance. Accreditation principles and measures will be discussed, and recent regulations on advanced therapy medicinal products which are more than minimally manipulated will be explained.

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References

  • Alici E, Blomberg P (2010) GMP facilities for manufacturing of advanced therapy medicinal products for clinical trials: an overview for clinical researchers. Curr Gene Ther 10:508–515

    Article  PubMed  CAS  Google Scholar 

  • Bartlett SE, Davidson WS (1992) FINS (forensically informative nucleotide sequencing): a procedure for identifying the animal origin of biological specimens. Biotechniques 12:408–411

    PubMed  CAS  Google Scholar 

  • Berardinelli F, Antoccia A, Cherubini R, et al. (2010) Telomere alterations and genomic instability in long-term cultures of normal human fibroblasts irradiated with X-rays and protons.doi: 10.1093/rpd/ncq486 [Epub ahead of print]

  • Brown B, Aaron M (2001) The politics of nature. In: Smith J (ed) The rise of modern genomics, 3rd edn. Wiley, New York

    Google Scholar 

  • Cheng L, Xiao L, Zeng F, Zhang YA (2008) Stem cells shine in Shanghai. Cell Stem Cell 2:34–37

    Article  PubMed  CAS  Google Scholar 

  • Commission Directive 2003/94/EC of 8 October 2003 laying down the principles and guidelines of good manufacturing practice in respect of medicinal products for human use and investigational medicinal products for human use. Official J Eur Union; L262:22–26

    Google Scholar 

  • Commission Directive 2004/23/EC of the European Parliament and of the Council of 31 March 2004 on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells. Official J Eur Union; L102:48–58

    Google Scholar 

  • Commission Directive 2006/17/EC of the Commission of the European Communities and of the Council of 8 February 2006 implementing Directive 2004/23/EC of the European Parliament and of the Council as regards certain technical requirements for the donation, procurement and testing of human tissues and cells. Oj L102:48

    Google Scholar 

  • Community E (2003a) EC guide to good manufacturing practice revision to annex 1 title: Manufacture of Sterile Medicinal Products Note: manufacture of sterile medicinal products. Official J Eur Union. OJ L 159, 27.6.2003, 1084/2003, p. 1–23

    Google Scholar 

  • Community E (2003b) EC guide to good manufacturing practice revision to annex 20 title: Manufacture of Sterile Medicinal Products Note: manufacture of sterile medicinal products. Official J Eur Union. OJ L 159, 27.6.2003, 1085/2003, p. 24–45

    Google Scholar 

  • Community E Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products. Off Journ 2001; L311:1–66

    Google Scholar 

  • Community E Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use. Off Journ 2001; L311:67–128

    Google Scholar 

  • Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use. Official J Eur Communities 2001; L121:34–44

    Google Scholar 

  • Dittmar KEJ, Simann M, Zghoul N et al (2010) Quality of cell products: authenticity, identity, genomic stability and status of differentiation. Transf Med Hemotherapy 37:57–64

    Google Scholar 

  • Drexler HG, Matsuo AY, MacLeod RA (2000) Continuous hematopoietic cell lines as model systems for leukemia-lymphoma research. Leuk Res 24:881–911

    Article  PubMed  CAS  Google Scholar 

  • European Commission (2008) EudraLex The Rules Governing Medicinal Products in the European Union, Volume 4 EU Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary Use, Part I Chapter 1 Quality Management:1–6

    Google Scholar 

  • F.D.A. 21 CFR Parts 16, 1270, and 1271 (2004) Current good tissue practice for human cell, tissue, and cellular and tissue- based product establishments; Inspection and enforcement; Final rule. Federal Register, 69:68612–68688

    Google Scholar 

  • Hay RJ (2002) Cell Quantitation and characterization. In: Atala A, Lanza RP (eds) Methods of tissue engineering. Academic, San Diego, pp 55–84

    Chapter  Google Scholar 

  • Jekerle V, Schröder C, Pedone E (2010) Legal basis of the advanced therapies regulation. Bundesgesundheitsbl 53:4–8

    Article  CAS  Google Scholar 

  • Kimura M, Stone RC, Hunt SC, et al (2010) Nat Protoc 5(9):1596–15607

    Article  CAS  Google Scholar 

  • Marshall TG, Marshall FE (2003) New treatments emerge as sarcoidosis yields up its secrets. ClinMed NetPrints. http://clinmed.netprints.org/cgi/content/full/2003010001v1 . Accessed 24 June 2004 Online document (no DOI available)

  • Montag T, Störmer M, Schurig U et al (2010) Probleme der mikrobiellen Sicherheit bei neuartigen Therapien [Problems of the microbiological safety in advanced therapies]. Bundesgesundheitsbl 53:45–51

    Article  Google Scholar 

  • Niini T, Lahti L, Michelacci F, et al (2011) Array comparative genomic hybridization reveals frequent alterations of G1/S checkpoint genes in undifferentiated pleomorphic sarcoma of bone. Genes Chromosomes Cancer doi: 10.1002/gcc.20851. [Epub ahead of print]

    Google Scholar 

  • Nims RW, Shoemaker AP, Bauernschub MA, Rec LJ, Harbell JW (1998) Sensitivity of isoenzyme analysis for the detection of interspecies cell line cross-contamination. In Vitro Cell Dev Biol Anim 34:35–39

    Article  PubMed  CAS  Google Scholar 

  • Regulation (EC) (1901/2006) of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric use and amending Regulation (EEC) 1768/92, Directive 2001/20/EC, Directive 2001/83/EC and Regulation (EC) 726/2004, L378:1–19

    Google Scholar 

  • Regulation (EC) (1394/2007) of the European Parliament and of the Council of 13 November 2007 on advanced therapy medicinal products amending Directive 2001/83/EC and Regulation (EC) 726/2004, L324:121–137

    Google Scholar 

  • Sensebe L, Krampera M, Schrezenmeier H, Bourin P, Giordano R (2010) Mesenchymal stem cells for clinical application. Int J Transf Med Vox Sanguinis 98:93–107

    Article  CAS  Google Scholar 

  • Signore A, Jacobs T (2005) Good design practices for GMP pharmaceutical facilities. Drugs and the Pharmaceutical Sciences. New York, Informa healthcare, pp 1–7

    Google Scholar 

  • Slifka MK, Whitton JL (2000) Clinical implications of dysregulated cytokine production. J Mol Med. doi:10.1007/s001090000086

  • South J, Blass B (2001) The future of modern genomics. Blackwell, London

    Google Scholar 

  • Stacey GN (2000) Cell contamination leads to inaccurate data: we must take action now. Nature 403:356

    Article  PubMed  CAS  Google Scholar 

  • Stacey GN (2002) Standardization of cell lines. Dev Biol (Basel) 111:259–272

    CAS  Google Scholar 

  • Unseld M, Beyermann B, Brandt P, Hiesel R (1995) Identification of the species origin of highly processed meat products by mitochondrial DNA sequences. PCR Methods Appl 4:241–243

    PubMed  CAS  Google Scholar 

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Correspondence to Reinhard Henschler .

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Oancea, G., Wagner, B., Henschler, R. (2012). Cell Therapy Regulations from a European Perspective. In: Allan, D., Strunk, D. (eds) Regenerative Therapy Using Blood-Derived Stem Cells. Stem Cell Biology and Regenerative Medicine. Humana Press. https://doi.org/10.1007/978-1-61779-471-1_14

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