Derivation of xeno-free and gmp-grade human embryonic stem cells - platforms for future clinical applications

PLoS ONE

Volumn 7, Issue 6, 2012, Pages

  Tannenbaum, Shelly E ^a   Turetsky, Tikva ^a   Singer, Orna ^a   Aizenman, Einat ^a   Kirshberg, Sophie ^a   Ilouz, Nili ^a   Gil, Yaniv ^a   Berman Zaken, Yael ^a   Perlman, Temima Schnitzer ^a   Geva, Nitshia ^a   Levy, Ora ^a   Arbell, Daniel ^a   Simon, Alex ^a   Ben Meir, Assaf ^a   Shufaro, Yoel ^a   Laufer, Neri ^a   Reubinoff, Benjamin E ^a  

^a HADASSAH HEBREW UNIVERSITY MEDICAL CENTER   (Israel)

Author keywords

[No Author keywords available]

Indexed keywords

BIOLOGICAL MARKER;

ARTICLE; CELL DIFFERENTIATION; CELL PROLIFERATION; CONTROLLED STUDY; CRYOPRESERVATION; DNA FINGERPRINTING; EMBRYO; EMBRYONIC STEM CELL; FETUS; FIBROBLAST CULTURE; FREEZE THAWING; GOOD LABORATORY PRACTICE; GOOD MANUFACTURING PRACTICE; HLA TYPING; HUMAN; HUMAN CELL; HUMAN TISSUE; IN VITRO STUDY; IN VIVO STUDY; KARYOTYPING; LABORATORY DIAGNOSIS; MEDICAL ETHICS; PLURIPOTENT STEM CELL; UMBILICAL CORD;

CELL CULTURE TECHNIQUES; EMBRYONIC STEM CELLS; HUMANS;

EID: 84862675002     PISSN: None     EISSN: 19326203     Source Type: Journal    
DOI: 10.1371/journal.pone.0035325     Document Type: Article

References (56)

1. Thomson JA, Itskovitz-Eldor J, Shapiro SS, Waknitz MA, Swiergiel JJ, et al. (1998) Embryonic stem cell lines derived from human blastocysts. Science 282: 1145-1147.
2. Reubinoff BE, Pera MF, Fong CY, Trounson A, Bongso A, (2000) Embryonic stem cell lines from human blastocysts: somatic differentiation in vitro. Nat Biotechnol 18: 399-404.
3. Nasonkin IO, Koliatsos VE, (2006) Nonhuman sialic acid Neu5Gc is very low in human embryonic stem cell-derived neural precursors differentiated with B27/N2 and noggin: implications for transplantation. Exp Neurol 201: 525-529.
4. Hovatta O, (2006) Derivation of human embryonic stem cell lines, towards clinical quality. Reprod Fertil Dev 18: 823-828.
5. Weber DJ, (2006) Manufacturing considerations for clinical uses of therapies derived from stem cells. Methods Enzymol 420: 410-430.
6. Fink DW Jr, (2009) FDA regulation of stem cell-based products. Science 324: 1662-1663.
7. Amit M, Itskovitz-Eldor J, (2002) Derivation and spontaneous differentiation of human embryonic stem cells. J Anat 200: 225-232.
8. Strom S, Inzunza J, Grinnemo KH, Holmberg K, Matilainen E, et al. (2007) Mechanical isolation of the inner cell mass is effective in derivation of new human embryonic stem cell lines. Hum Reprod 22: 3051-3058.
9. Liu W, Yin Y, Long X, Luo Y, Jiang Y, et al. (2009) Derivation and characterization of human embryonic stem cell lines from poor quality embryos. J Genet Genomics 36: 229-239.
10. Turetsky T, Aizenman E, Gil Y, Weinberg N, Shufaro Y, et al. (2008) Laser-assisted derivation of human embryonic stem cell lines from IVF embryos after preimplantation genetic diagnosis. Hum Reprod 23: 46-53.
11. Cortes JL, Sanchez L, Catalina P, Cobo F, Bueno C, et al. (2008) Whole-blastocyst culture followed by laser drilling technology enhances the efficiency of inner cell mass isolation and embryonic stem cell derivation from good- and poor-quality mouse embryos: new insights for derivation of human embryonic stem cell lines. Stem Cells Dev 17: 255-267.
12. Richards M, Fong CY, Chan WK, Wong PC, Bongso A, (2002) Human feeders support prolonged undifferentiated growth of human inner cell masses and embryonic stem cells. Nat Biotechnol 20: 933-936.
13. Simon C, Escobedo C, Valbuena D, Genbacev O, Galan A, et al. (2005) First derivation in Spain of human embryonic stem cell lines: use of long-term cryopreserved embryos and animal-free conditions. Fertil Steril 83: 246-249.
14. Fong CY, Bongso A, (2006) Derivation of human feeders for prolonged support of human embryonic stem cells. Methods Mol Biol 331: 129-135.
15. Ellerstrom C, Strehl R, Moya K, Andersson K, Bergh C, et al. (2006) Derivation of a xeno-free human embryonic stem cell line. Stem Cells 24: 2170-2176.
16. Fu X, Toh WS, Liu H, Lu K, Li M, et al. (2011) Establishment of clinically compliant human embryonic stem cells in an autologous feeder-free system. Tissue Eng Part C Methods 17: 927-937.
17. Klimanskaya I, Chung Y, Meisner L, Johnson J, West MD, et al. (2005) Human embryonic stem cells derived without feeder cells. Lancet 365: 1636-1641.
18. Sjogren-Jansson E, Zetterstrom M, Moya K, Lindqvist J, Strehl R, et al. (2005) Large-scale propagation of four undifferentiated human embryonic stem cell lines in a feeder-free culture system. Dev Dyn 233: 1304-1314.
19. Ludwig TE, Bergendahl V, Levenstein ME, Yu J, Probasco MD, et al. (2006) Feeder-independent culture of human embryonic stem cells. Nat Methods 3: 637-646.
20. Steiner D, Khaner H, Cohen M, Even-Ram S, Gil Y, et al. (2010) Derivation, propagation and controlled differentiation of human embryonic stem cells in suspension. Nat Biotechnol 28: 361-364.
21. Rajala K, Hakala H, Panula S, Aivio S, Pihlajamaki H, et al. (2007) Testing of nine different xeno-free culture media for human embryonic stem cell cultures. Hum Reprod 22: 1231-1238.
22. Rodin S, Domogatskaya A, Strom S, Hansson EM, Chien KR, et al. (2010) Long-term self-renewal of human pluripotent stem cells on human recombinant laminin-511. Nat Biotechnol 28: 611-615.
23. Villa-Diaz LG, Nandivada H, Ding J, Nogueira-de-Souza NC, Krebsbach PH, et al. (2010) Synthetic polymer coatings for long-term growth of human embryonic stem cells. Nat Biotechnol 28: 581-583.
24. Crook JM, Peura TT, Kravets L, Bosman AG, Buzzard JJ, et al. (2007) The Generation of Six Clinical-Grade Human Embryonic Stem Cell Lines. Cell Stem Cell 1: 490-494.
25. Ellerstrom C, Strehl R, Noaksson K, Hyllner J, Semb H, (2007) Facilitated expansion of human embryonic stem cells by single-cell enzymatic dissociation. Stem Cells 25: 1690-1696.
26. Thomson A, Wojtacha D, Hewitt Z, Priddle H, Sottile V, et al. (2008) Human embryonic stem cells passaged using enzymatic methods retain a normal karyotype and express CD30. Cloning Stem Cells 10: 89-106.
27. Ilic D, Stephenson E, Wood V, Jacquet L, Stevenson D, et al. (2012) Derivation and feeder-free propagation of human embryonic stem cells under xeno-free conditions. Cytotherapy 14: 122-128.
28. Coecke S, Balls M, Bowe G, Davis J, Gstraunthaler G, et al. (2005) Guidance on good cell culture practice. A report of the second ECVAM task force on good cell culture practice. Altern Lab Anim 33: 261-287.
29. (2006) Ancillary Materials for Cell, Gene, and Tissue-Engineered Therapy Products 29 NF 24, United States Pharmacopia. Available:http://www.pharmacopeia.cn/v29240/usp29nf24s0_c1043.html. Accessed October 16, 2007.
30. (2004) Guidance for Industry Sterile Drug Products Produced by Aseptic Processing-Current Good Manufacturing Practice. Rockville, Maryland: US Food and Drug Administration. Available:http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM070342.pdf. Accessed February 26, 2005.
31. (2006) (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. Official Journal of the European Union COMMISSION DIRECTIVE 2006/17/EC. Accessed March 11.
32. (1997) Q5D: Derivation and Characterization of Cell Substrates Used for Production of Biotechnological/Biological Products. International Conference on Harmonization. Available:http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM129103.pdf. Accessed August 15, 2007.
33. (1985) Inspections, Compliance, Enforcement, and Criminal Investigations: Bacterial Endotoxins/Pyrogens. Washington (D.C.) Food and Drug Administration: Available:http://www.fda.gov/ICECI/Inspections/InspectionGuides/InspectionTechnicalGuides/ucm072918.htm. Accessed January 12, 2010.
34. (2004) Eligibility determination for donors of human cells, tissues, and cellular and tissue-based products. Final rule. Fed Regist 69: 29785-29834.
35. (2001) Guidance for human somatic cell therapy and gene therapy. Hum Gene Ther 12: 303-314.
36. Adewumi O, Aflatoonian B, Ahrlund-Richter L, Amit M, Andrews PW, et al. (2007) Characterization of human embryonic stem cell lines by the International Stem Cell Initiative. Nat Biotechnol 25: 803-816.
37. (1987) The Status of the Extra-Corporeal Embryo Country Report: Israel. 5035, 11 June 1987, Israel: Israeli Official Gazette. Available:http://bioethics.academy.ac.il/hebrew/articles/The_Status_of_the_Extra-corporel_Embryo.htm. Accessed.
38. (2004) Prohibition of Genetic Intervention (Human Cloning and Genetic Modification of Reproductive Cells)- Amendment. Israel: Official Gazette. Available:http://bioethics.academy.ac.il/english/articles/The_Status_of_the_Extra-corporel_Embryo.htm#_ftn8. Accessed January 23, 2010.
39. Revel M, (2003) Human reproductive cloning, embryo stem cells and germline gene intervention: an Israeli perspective. Med Law 22: 701-732.
40. Carpenter MK, Frey-Vasconcells J, Rao MS, (2009) Developing safe therapies from human pluripotent stem cells. Nat Biotechnol 27: 606-613.
41. Murdoch A, Braude P, Courtney A, Brison D, Hunt C, et al. (2011) The Procurement of Cells for the Derivation of Human Embryonic Stem Cell Lines for Therapeutic Use: Recommendations for Good Practice. Stem Cell Rev.
42. Strom S, Holm F, Bergstrom R, Stromberg AM, Hovatta O, (2010) Derivation of 30 human embryonic stem cell lines-improving the quality. In Vitro Cell Dev Biol Anim 46: 337-344.
43. Cowan CA, Klimanskaya I, McMahon J, Atienza J, Witmyer J, et al. (2004) Derivation of embryonic stem-cell lines from human blastocysts. N Engl J Med 350: 1353-1356.
44. Hewitt ZA, Amps KJ, Moore HD, (2007) Derivation of GMP raw materials for use in regenerative medicine: hESC-based therapies, progress toward clinical application. Clin Pharmacol Ther 82: 448-452.
45. Reubinoff BE, Pera MF, Vajta G, Trounson AO, (2001) Effective cryopreservation of human embryonic stem cells by the open pulled straw vitrification method. Hum Reprod 16: 2187-2194.
46. Amps KJ, Jones M, Baker D, Moore HD, (2010) In situ cryopreservation of human embryonic stem cells in gas-permeable membrane culture cassettes for high post-thaw yield and good manufacturing practice. Cryobiology 60: 344-350.
47. Nelson-Rees WA, Daniels DW, Flandermeyer RR, (1981) Cross-contamination of cells in culture. Science 212: 446-452.
48. Gilbert DA, Reid YA, Gail MH, Pee D, White C, et al. (1990) Application of DNA fingerprints for cell-line individualization. Am J Hum Genet 47: 499-514.
49. Stacey G, Doyle A, Hay R, Johnson R, Beck J, et al. (2003) Cell Banks: A Service to Animal Cell Technology. In: Scragg BGaAH, editors. editor. Encyclopedia of Cell Technology: John Wiley & Sons, Inc. ~1,200.79.
50. Markovic O, Markovic N, (1998) Cell cross-contamination in cell cultures: the silent and neglected danger. In Vitro Cell Dev Biol Anim 34: 1-8.
51. Stacey GN, (2000) Cell contamination leads to inaccurate data: we must take action now. Nature 403: 356.
52. Crook JMH, D. & Stacey, G (2010) International Stem Cell Banking Initiative: raising standards to bank on. In Vitro CellDevBiol-Animal 46: 169-172.
53. Claussen U, Schafer H, Trampisch HJ, (1984) Exclusion of chromosomal mosaicism in prenatal diagnosis. Hum Genet 67: 23-28.
54. Stephenson E, Ogilvie CM, Patel H, Cornwell G, Jacquet L, et al. (2010) Safety paradigm: genetic evaluation of therapeutic grade human embryonic stem cells. J R Soc Interface 7: S677-688.
55. Yao S, Chen S, Clark J, Hao E, Beattie GM, et al. (2006) Long-term self-renewal and directed differentiation of human embryonic stem cells in chemically defined conditions. Proc Natl Acad Sci U S A 103: 6907-6912.
56. Itsykson P, Ilouz N, Turetsky T, Goldstein RS, Pera MF, et al. (2005) Derivation of neural precursors from human embryonic stem cells in the presence of noggin. Mol Cell Neurosci 30: 24-36.