Skip to main content

Perspectives, Ethics and Clinical Issues in the Use of Primary Human Cells

  • Chapter
  • 312 Accesses

Part of the book series: Human Cell Culture ((HUCC,volume 4))

This is a preview of subscription content, log in via an institution.

Buying options

Chapter
USD   29.95
Price excludes VAT (USA)
  • Available as PDF
  • Read on any device
  • Instant download
  • Own it forever
eBook
USD   169.00
Price excludes VAT (USA)
  • Available as PDF
  • Read on any device
  • Instant download
  • Own it forever
Softcover Book
USD   219.99
Price excludes VAT (USA)
  • Compact, lightweight edition
  • Dispatched in 3 to 5 business days
  • Free shipping worldwide - see info
Hardcover Book
USD   219.99
Price excludes VAT (USA)
  • Durable hardcover edition
  • Dispatched in 3 to 5 business days
  • Free shipping worldwide - see info

Tax calculation will be finalised at checkout

Purchases are for personal use only

Learn about institutional subscriptions

Preview

Unable to display preview. Download preview PDF.

Unable to display preview. Download preview PDF.

References

  1. Dresselhaus MS (1998). What scientists can do to fight the Frankenstein myth. The Scientist, Philadelphia.

    Google Scholar 

  2. Keyes CD and Wiest WE (eds.) (1991) New Harvest: Transplanting Body Parts and Reaping the Benefits. Humana Press, Clifton.

    Google Scholar 

  3. Mathieu D (1988) Organ Substitution Technology: Ethical, Legal, and Public Policy Issues. Westview Press, Boulder & London.

    Google Scholar 

  4. Palmer JG (1994) Human gene therapy: suggestions for avoiding liability. Ann. NY Acad. Sci. 716:294–305. discussion 305–306.

    PubMed  CAS  Google Scholar 

  5. Demmy TL and Magovern GA (1991) History of transplantation and future trends, in CD Keyes and WE Wiest (eds.), New Harvest: Transplanting Body Parts and Reaping the Benefits, Humana Press, Clifton.

    Google Scholar 

  6. Kletzel M, Morgan E, and Frader J (1998) Editorial: Ethical issues in stem cell transplantation. J. Hematotherapy 7: 197–204.

    CAS  Google Scholar 

  7. Swazey JP (1992) Spare parts: Organ replacement in American Society. New York: Oxford University Press.

    Google Scholar 

  8. Wailoo K (1997) Drawing Blood: Technology and Disease in Twentieth Century America. Johns Hopkins University Press, Baltimore.

    Google Scholar 

  9. Report of the Task Force on Organ Transplantation (1986). U.S. Dept of Health and Human Services, Washington DC

    Google Scholar 

  10. Blumstein JF and Sloan FA (eds.), (1988). Organ Transplantation Policy: Issues and Prospects, Duke University Press, Durham and London.

    Google Scholar 

  11. Blumstein JF (1988) Government’s role in organ transplantation policy, in JF Blumstein and FA Sloan (eds.), Organ Transplantation Policy: Issues and Prospects, Duke University Press, Durham and London.

    Google Scholar 

  12. Arnold RM, Youngner SJ, Schapiro R, and Spicer CM (1995) Procuring Organs for Transplant: The Debate over Non-Heart-Renting Cadaver Protocols, Johns Hopkins. Baltimore.

    Google Scholar 

  13. Bell NM (1994) Regulating transfer and use of fetal tissue in transplantation procedures: the ethical dimensions. Am. J. Law Med. 20:277–294.

    PubMed  CAS  Google Scholar 

  14. Rojansky N and Schenker JG (1993) The use of fetal tissues for therapeutic application. Int.J. Gynaecol. Obstet. 41:233–240.

    Article  PubMed  CAS  Google Scholar 

  15. National Commission on the Protection of Human Subjects (1975) “Fetal Viability and Death, ” Report and Recommendations: Research on the Fetus, DHEW Publ. No. (05) 76–127.

    Google Scholar 

  16. Hansmann H (1988) The economics and ethics of markets lor human organs, in JF Blumstein and FA Sloan (eds.), Organ Transplantation Policy: Issues and Prospects, Duke University Press. Durham and London.

    Google Scholar 

  17. Moore vs. The University of California Regents. (1988) 249 Cal Regents (Cal App., 2nd District.

    Google Scholar 

  18. Office of Technology Assessment (1987) New Developments in Biotechnology: Ownership of Human Tissues and Cells: Special Report, US Govt. Printing Office, Washington DC.

    Google Scholar 

  19. Matthews P (1983) Whose body? People as property. Curr. Leg. Probl. 1983:193–239.

    Google Scholar 

  20. Korbling M and Fliedner TM (1996) The evolution of clinical PB stem cell transplantation. BM Transplant. 17:765–678.

    Google Scholar 

  21. Lee JH and Klein HG (1995) Cellular gene therapy. Hematol. Oncol. Clinics of North America 9:91–113.

    CAS  Google Scholar 

  22. Snyder EL (1995) Hematopoietic cell therapy and transfusion medicine-carpe diem? Transfusion 35:371–373

    Article  PubMed  CAS  Google Scholar 

  23. Karlsson S (1997) Gene therapy of hematopoietic cells J. Intern. Med. 740:95–99.

    CAS  Google Scholar 

  24. Orkin SH and Motulsky AG (1995) Report and recommendations of the panel to assess the NIH investment in research on gene therapy. NIH. US Govt Printing Office, Washington DC.

    Google Scholar 

  25. Gale RP, Juttner CA, and Henon P (1994) Blood Stern Cell Transplants, Cambridge University Press, Cambridge.

    Google Scholar 

  26. Slavin S et al. (1998) Nonmyeloablative stem cell transplantation and cell therapy as an alternative to conventional BM transplantation with lethal cytoreduction for the treatment of malignant and nonmalignant hematologic diseases. Blood 91:756–763.

    PubMed  CAS  Google Scholar 

  27. Yee GC (1996) The future of cell therapy. Pharmacotherapy 16:109S–115S.

    PubMed  CAS  Google Scholar 

  28. Gluckman JC et al. (1997) In vitro generation of human dendritic cells and cell therapy. Cytokines Cell Mol. Ther. 3:187–196.

    PubMed  CAS  Google Scholar 

  29. Riddell SR et al. (1995) Principles for adoptive T cell therapy of human viral diseases. Ann. Rev. lmmunol. 13:545–586.

    CAS  Google Scholar 

  30. Yee C et al. (1997) Prospects for adoptive T cell therapy. Curr. Opin. lmmunol. 9:702708

    Google Scholar 

  31. Dalemans W (1994). From in vitro to in vivo: Progress in the use of cultured cells for human therapy. Cytotechnology 16:189–194.

    Article  PubMed  CAS  Google Scholar 

  32. Freshney RI (1992) Culture of Animal Cells: A Manual of Basic Technique, IRL Press, New York.

    Google Scholar 

  33. Moyer MP (1989) Human cell models for genetic engineering. Medical Progress Through Technology Series, 15:83–100.

    CAS  Google Scholar 

  34. Lanza RP and Chick WL (1996) Yearbook of Cell and Tissue Transplantation 1996/1997, Kluwer Academic Publishers, Dordrecht and Boston.

    Google Scholar 

  35. Dunbar CE and Young NS (1996) Gene marking and gene therapy directed at primary hematopoietic cells. Curr. Opin. Hemat. 3:430–437.

    CAS  Google Scholar 

  36. Lewis BS, Flugelman MY, Weisz A, Keren-Tal I, and Schaper W (1997) Angiogenesis by gene therapy: a new horizon for myocardial revascularization? Cardiovasc Res 35:490–497.

    Article  PubMed  CAS  Google Scholar 

  37. Imai E and Isaka Y (1998). Strategies of gene transfer to the kidney. Kidney Int. 53:264–272.

    Article  PubMed  CAS  Google Scholar 

  38. Woods JD et al. (1997) Prospects for the bioartificial kidney. Semin. Nephrology 17:381–386.

    CAS  Google Scholar 

  39. Hayflick L, Plotkin S, Stevenson RE (1986) History of the acceptance of human diploid cell strains as substrates for human virus vaccine manufacture. Develop. Biol. Standard. 68:9–17.

    Google Scholar 

  40. US Food and Drug Administration (FDA) (1993) Application of current statutory authorities to human somatic cell therapy products and gene therapy products. Federal Register Notice, Oct. 14.

    Google Scholar 

  41. US Food and Drug Administration (FDA) (1985) Points to consider in the design and submission of human somatic cell gene therapy. Recomb. DNA Tech. Bullet. 8:181–186.

    Google Scholar 

  42. Office of Biologics Research and Review (1987) Points to Consider in the Characterization of Cell Lines to Produce Biologicals, FDA, Bethesda, MD.

    Google Scholar 

  43. WHO Study Group (1987) Acceptability of Cell Substrates for Production of Biologicals, Technical Report (No. 747) of a WHO Study Group, World Health Organization, Geneva.

    Google Scholar 

  44. International Association of Biological Standardization (IABS), (acting editors: L. Hayflick and W. Hennessen), (1989) Continuous Cell Lines as Substrates for Biologicals, Developments in Biological Standardization, Vol. 70, Karger, Basel.

    Google Scholar 

  45. Moyer MP and Moyer RC (1986) Potential risks of tumor virus subgenomes in the production of biologicals. Develop. Biol. Standard. 68:51–62.

    Google Scholar 

  46. Berg P, Baltimore D, Brenner S, Roblin RO, Singer MF (1975) Summary statement of the Asilomar conference on recombinant DNA molecules. Proc. Natl. Acad. Sci. USA 72:1981–1984.

    PubMed  CAS  Google Scholar 

  47. Kessler DA, Siegel JP, Noguchi PD, et al. (1993) Regulation of somatic cell and gene therapy by the Food and Drug Administration. N. Engl. J. Med. 329:1169–1173.

    Article  PubMed  CAS  Google Scholar 

  48. Friedman T (1993) Milestones and events in the early development of human gene therapy. Molec. Genet. Med. 3:1–32.

    Google Scholar 

  49. Jenks S (1997) Genes to order: regulators struggle against future abuses. JNCI 89: 1478–1479.

    PubMed  CAS  Google Scholar 

  50. Wolff JA and Lederberg J (1994) An early history of gene transfer and gene therapy. Human Gene Therapy 5:469–480.

    PubMed  CAS  Google Scholar 

  51. Sandhu JS, Keating A, and Hozumi N (1997) Human Gene Therapy. Crit. Rev. Biotechnol. 17:307–326.

    PubMed  CAS  Google Scholar 

  52. Epstein S (1996) Addendum to the points to consider in human somatic cell and gene therapy. Human Gene Therapy 7:1181–1190.

    PubMed  CAS  Google Scholar 

  53. Anderson WF (1985) Human gene therapy: scientific and ethical considerations. Recomb. DNA Tech. Bull. 8:55–63.

    PubMed  CAS  Google Scholar 

  54. Bankowski A and JH Bryant (eds) 1994. Poverty, vulnerability, and the value of human life: A global agenda for bioethics. Highlights and Papers of the XXVIIIth CIOMS Conference, CIOMS.

    Google Scholar 

  55. Childress JF (1989) Ethical criteria for procuring and distributing organs for transplantation. J. Health Polit. Policy Law 14:87–113.

    PubMed  CAS  Google Scholar 

  56. Eisenberg VH and Schenker JG (1997) Genetic engineering: moral aspects and control of practice. J. Assisted Reprod. Genet. 14:297–316.

    CAS  Google Scholar 

  57. McGleenan T (1995) Human gene therapy and slippery slope arguments. J. Med. Ethics 21:350–355.

    Article  PubMed  CAS  Google Scholar 

  58. World Health Organization. Human Organ Transplantation: A Report on Developments under the Auspices of WHO (1987–1991). Int. Dig. Health Legis. 42:389–413.

    Google Scholar 

  59. President’s Commission for the Study of Ethical Problems in Medicine and Biobehavioral Research (1981) Defining Death, US Govt. Printing Office, Washington DC.

    Google Scholar 

  60. Connor SS, and HL Fuenzalida-Puelma (eds.) (1990). Bioethics Issues and Perspectives. DAHO Scientific Publication No. 527, DAHO.

    Google Scholar 

  61. Goodman E (1998) The organ trade. The Boston Globe (3/8/98).

    Google Scholar 

  62. Greenberg W & Kamin D (1993) Property rights and payment to patients for cell lines derived from human tissues: an economic analysis. Social Sci. Med. 36:1071–1076.

    CAS  Google Scholar 

  63. Burgio GR and F Locatelli (1997) Transplant of BM and CB hematopoietic stem cells in pediatric practice, revisited according to the fundamental principles of bioethics, BM Transplant. 19:1163–1168.

    CAS  Google Scholar 

  64. Auerbach AD (1994) Umbilical CB transplants for genetic diseases: diagnostic and ethical issues in fetal studies. Blood Cells 20:303–309.

    PubMed  CAS  Google Scholar 

  65. Lind SE (1994) Ethical considerations related to the collection and distribution of CB stem cells for transplantation to reconstitute hematopoietic function. Transfusion 34:828–834; (Comment in)-1995. Transfusion 35: 967–968.

    Article  PubMed  CAS  Google Scholar 

  66. Marshall E (1996) Clinical promise, ethical quandary. Science 271:586–588.

    PubMed  CAS  Google Scholar 

  67. Sugarman J, Kaalund V, Kodish E, Marshall MF, Reisner EG, Wilfond BS, and Wolpe PR (1997) Ethical issues in umbilical CB banking. JAMA 278:938–943.

    Article  PubMed  CAS  Google Scholar 

  68. Newman-Gage H (1996) Fetal tissue banking: standards and regulatory issues. J. Hematotherapy 5:189–193.

    CAS  Google Scholar 

  69. O’Neil B (1996) Implementing a validation program in a CB bank. J. Hematotherapy. 5:139–143.

    Google Scholar 

  70. Reece EA (1997) Embryoscopy and early prenatal diagnosis. Obstet. Gynecol. Clin. North Amer. 24:111–121.

    CAS  Google Scholar 

  71. Flake AW and Zanjani EJ (1997) In utero hematopoietic stem cell transplantation. A status report. JAMA 278:932–937.

    Article  PubMed  CAS  Google Scholar 

  72. Pergament E et al. (1995) Prenatal gene therapy: prospects and issues. Prenat. Diagn. 15:1303–1311.

    PubMed  CAS  Google Scholar 

  73. Vawter DE, Kearney W, Gervais KG, Caplan AL, Carry D, and Tauer C (1990) The Use of Human Fetal Tissue: Scientific, Ethical, and Policy Concerns. University of Minnesota, Minneapolis.

    Google Scholar 

  74. Tichtchenko P and Yudin B (1997) The moral status of fetuses in Russia. Cambridge Quarterly Healthcare Ethics 6:31–8.

    CAS  Google Scholar 

  75. Sade RM (1994) Issues of social policy and ethics in gene technology. Methods Find. Exp. Clin. Pharmacol. 16:477–489.

    PubMed  CAS  Google Scholar 

  76. Robbins PD, Tahara H, and Ghivizzani SC (1998) Viral vectors for gene therapy. Trends Biotechnol. 16:35–40.

    Article  PubMed  CAS  Google Scholar 

  77. Wilmut I, Schnieke AE, McWhir J, Kind AJ, and Campbell KHS (1997) Viable offspring from fetal and adult mammalian cells. Nature 385:810–813.

    Article  PubMed  CAS  Google Scholar 

  78. Gavaghan H (1994) Fetal gene therapy under the microscope. Nature 372:490.

    CAS  Google Scholar 

  79. Glaser V (1997) Novartis licenses gene therapy to avoid monopoly. Nature Biotechnol. 15:118–119.

    CAS  Google Scholar 

  80. Juengst ET (1990) The NIH “Points to Consider” and the limits of human gene therapy. Hum. Gene Therapy 1:425–433.

    CAS  Google Scholar 

  81. Lindemann et al. (1995) Guidelines for the design and implementation of clinical studies in somatic cell therapy and gene therapy. The German Working Group for Gene Therapy. J. Mol. Med. 73:207–211.

    Article  PubMed  CAS  Google Scholar 

  82. duMoulin GC, Pitkin Z, Shen YJ, Conti E, Stewart JK, Charles C, and Hamilton D (1994) Overview of quality assurance/quality control compliance program consistent with FDA regulations and policies for somatic cell and gene therapies: a four year experience. Cytotechnology 15:365–72.

    Article  PubMed  Google Scholar 

  83. Institute of Medicine (1996) Xenotransplantation: Science, Ethics, and Public Policy. National Academy Press, Washington, DC.

    Google Scholar 

  84. Scott R (1981) The Body as Property, Viking Press, New York.

    Google Scholar 

Download references

Author information

Authors and Affiliations

Authors

Editor information

Editors and Affiliations

Rights and permissions

Reprints and permissions

Copyright information

© 2002 Kluwer Academic Publishers

About this chapter

Cite this chapter

Moyer, M.P. (2002). Perspectives, Ethics and Clinical Issues in the Use of Primary Human Cells. In: Koller, M.R., Palsson, B.O., Masters, J.R.W. (eds) Human Cell Culture. Human Cell Culture, vol 4. Springer, Dordrecht. https://doi.org/10.1007/0-306-46886-7_13

Download citation

  • DOI: https://doi.org/10.1007/0-306-46886-7_13

  • Publisher Name: Springer, Dordrecht

  • Print ISBN: 978-0-7923-5821-3

  • Online ISBN: 978-0-306-46886-5

  • eBook Packages: Springer Book Archive

Publish with us

Policies and ethics