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Volumn 53, Issue , 2014, Pages 189-200

Regulatory issues in cell-based therapy for clinical purposes

Author keywords

[No Author keywords available]

Indexed keywords

ANIMAL; BIOLOGICAL THERAPY; HUMAN; MEDICAL RESEARCH; MEDICOLEGAL ASPECT; PROCEDURES; RETINAL DISEASES; STANDARDS;

EID: 84922284496     PISSN: 02503751     EISSN: 16622790     Source Type: Book Series    
DOI: 10.1159/000357766     Document Type: Article
Times cited : (4)

References (19)
  • 3
    • 84876039545 scopus 로고    scopus 로고
    • Manufacturing and banking of mesenchymal stem cells
    • Thirumala S, Goebel W, Woods EJ: Manufacturing and banking of mesenchymal stem cells. Expert Opin Biol Ther 2013; 13: 673-691.
    • (2013) Expert Opin Biol Ther , vol.13 , pp. 673-691
    • Thirumala, S.1    Goebel, W.2    Woods, E.J.3
  • 5
    • 67650506083 scopus 로고    scopus 로고
    • Developing safe therapies from human pluripotent stem cells
    • Carpenter MK, Frey-Vasconcells J, Rao MS: Developing safe therapies from human pluripotent stem cells. Nat Biotechnol 2009; 27: 606-613.
    • (2009) Nat Biotechnol , vol.27 , pp. 606-613
    • Carpenter, M.K.1    Frey-Vasconcells, J.2    Rao, M.S.3
  • 6
    • 84860993047 scopus 로고    scopus 로고
    • Cryopreservation of human vascular umbilical cord cells under good manufacturing practice conditions for future cell banks
    • Polchow B, Kebbel K, Schmiedeknecht G, Reichardt A, Henrich W, Hetzer R, Lueders C: Cryopreservation of human vascular umbilical cord cells under good manufacturing practice conditions for future cell banks. J Transl Med 2012; 10: 98.
    • (2012) J Transl Med , vol.10 , pp. 98
    • Polchow, B.1    Kebbel, K.2    Schmiedeknecht, G.3    Reichardt, A.4    Henrich, W.5    Hetzer, R.6    Lueders, C.7
  • 7
    • 77954788920 scopus 로고    scopus 로고
    • Regulatory considerations for the development of autologous induced pluripotent stem cell therapies
    • Carpenter MK, Couture LA: Regulatory considerations for the development of autologous induced pluripotent stem cell therapies. Regen Med 2010; 5: 569-579.
    • (2010) Regen Med , vol.5 , pp. 569-579
    • Carpenter, M.K.1    Couture, L.A.2
  • 8
    • 84872922024 scopus 로고    scopus 로고
    • Examination of the regulatory frameworks applicable to biologic drugs (including stem cells and their progeny) in Europe
    • the U.S., and Australia. I. A method of manual documentary analysis
    • Ilic N, Savic S, Siegel E, Atkinson K, Tasic L: Examination of the regulatory frameworks applicable to biologic drugs (including stem cells and their progeny) in Europe, the U.S., and Australia. I. A method of manual documentary analysis. Stem Cells Transl Med 2012; 1: 898-908.
    • (2012) Stem Cells Transl Med , vol.1 , pp. 898-908
    • Ilic, N.1    Savic, S.2    Siegel, E.3    Atkinson, K.4    Tasic, L.5
  • 9
    • 84872946357 scopus 로고    scopus 로고
    • Examination of the regulatory frameworks applicable to biologic drugs (including stem cells and their progeny) in Europe
    • the U.S., and Australia, II. A method of software documentary analysis
    • Ilic N, Savic S, Siegel E, Atkinson K, Tasic L: Examination of the regulatory frameworks applicable to biologic drugs (including stem cells and their progeny) in Europe, the U.S., and Australia. II. A method of software documentary analysis. Stem Cells Transl Med 2012; 1: 909-920.
    • (2012) Stem Cells Transl Med , vol.1 , pp. 909-920
    • Ilic, N.1    Savic, S.2    Siegel, E.3    Atkinson, K.4    Tasic, L.5
  • 10
    • 84874217844 scopus 로고    scopus 로고
    • Cell therapy medicinal product regulatory framework in Europe and its application for MSC-based therapy development
    • Ancans J: Cell therapy medicinal product regulatory framework in Europe and its application for MSC-based therapy development. Front Immunol 2012; 3: 253.
    • (2012) Front Immunol , vol.3 , pp. 253
    • Ancans, J.1
  • 11
    • 80054099313 scopus 로고    scopus 로고
    • CAT Secretariat & US Food and Drug Administration
    • European Medicines Agency
    • European Medicines Agency, CAT Secretariat & US Food and Drug Administration. Regen Med 2011; 6(suppl): 90-96.
    • (2011) Regen Med , vol.6 , pp. 90-96
  • 13
    • 2542465496 scopus 로고    scopus 로고
    • Proposed approach to regulation of cellular and tissue-based products
    • Proposed approach to regulation of cellular and tissue-based products. The Food and Drug Administration. 1997. http://www.fda.gov/downloads/ BiologicsBloodVaccines/ Guidance ComplianceRegulatoryInformation/ Guidances/Tissue/UCM062601.pdf.
    • (1997) The Food and Drug Administration
  • 14
    • 34547890682 scopus 로고    scopus 로고
    • Infrastructure development for human cell therapy translation
    • Dietz AB, Padley DJ, Gastineau DA: Infrastructure development for human cell therapy translation. Clin Pharmacol Ther 2007; 82: 320-324.
    • (2007) Clin Pharmacol Ther , vol.82 , pp. 320-324
    • Dietz, A.B.1    Padley, D.J.2    Gastineau, D.A.3
  • 15
    • 2542465496 scopus 로고    scopus 로고
    • Guidance for Industry, Regulation of human cells, tissues, and cellular and tissue-based products (HCT/Ps)-small entity compliance guide
    • Guidance for Industry: Regulation of human cells, tissues, and cellular and tissue-based products (HCT/Ps)-small entity compliance guide. The Food and Drug Administration. 2007. http://www. fda.gov/BiologicsBloodVaccines/ Guidan ceComplianceRegulatoryInformation/ Guidances/Tissue/ucm073366.pdf.
    • (2007) The Food and Drug Administration
  • 16
    • 84928244111 scopus 로고    scopus 로고
    • Reflection paper on classification of advanced therapy medicinal products. Committee for Advanced Therapies. European Medicines Agency. 2012.
    • Reflection paper on classification of advanced therapy medicinal products. Committee for Advanced Therapies. European Medicines Agency. 2012. http://www.ema.europa.eu/docs/en GB/document-library/Regulatory-and procedural-guideline/2012/04/ WC500126681.pdf.
  • 17
    • 84928244110 scopus 로고    scopus 로고
    • Guide to safety and quality assurance for organs, tissues and cells. Strasbourg, Council of Europe Publishing, ed 2.
    • Guide to safety and quality assurance for organs, tissues and cells. Strasbourg, Council of Europe Publishing, ed 2. 2004. http://www.coe.int/t/dg3/health/ Source/GuideSecurity2-en.pdf.
    • (2004)
  • 18
    • 84928244109 scopus 로고    scopus 로고
    • Guideline on human cell-based medicinal products. Committee for Medicinal Product for Human Use. European Medicines Agency
    • Guideline on human cell-based medicinal products. Committee for Medicinal Product for Human Use. European Medicines Agency. 2008. http://www. ema.europa.eu/docs/en-GB/document library/Scientific-guideline/2009/09/ WC500003894.pdf.
    • (2008)
  • 19
    • 84928244108 scopus 로고    scopus 로고
    • Good manufacturing practice (GMP) Guidelines. The rules governing medicinal products in the European Union. EudraLex
    • Good manufacturing practice (GMP) Guidelines. The rules governing medicinal products in the European Union. EudraLex, vol 4, 2011. http://ec.europa. eu/health/documents/eudralex/vol-4/ index-en.htm.
    • (2011) , vol.4


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.