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Bioethics and Freedom of Scientific Research in Gene Therapy and Stem Cell Biology

  • Conference paper
Biotech Innovations and Fundamental Rights

Abstract

Several projects and research fields are expected to strongly contribute to solving therapeutic or diagnostic issues by providing new technological solutions for molecular healthcare. One example, related to diagnosis, is the innovation in the field of development of workflows, methods and devices for analysis (even multiplexed) of biomarkers (RNA and proteins in live cells) and high throughput molecular diagnostics for personalized therapy. On the other hand, novel technologies related to regenerative medicine have brought great promises for the treatment of a large number of human disease, but also relevant ethical issues that are expected to limit significantly the freedom of research in several states, many of them belonging to the European Union. This is especially related with the research on human embryonic stem cells (hESCs), which is expected to bring important novelty in developing approaches in regenerative medicine. On the other hand, the ban of patenting invention based on embryonic stem cells appears to limit this approach, since scientists working in stem cell medicine will not be able to deliver clinical benefits without the involvement of biological industry, which must have patent protection as an incentive to be involved in this research activity.

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Notes

  1. 1.

    T. Caulfield et al. Research ethics recommendations for whole-genome research: consensus statement. PLoS Biol, 2008, 6:e73.

  2. 2.

    AL. McGuireet al. Research ethics and the challenge of whole-genome sequencing. Nat Rev Genet, 2008, Vol. 9, at 152–156.

  3. 3.

    A. Flynn, T. O’Brien. Stem cell therapy for cardiac disease. Expert Opin Biol Ther, 2011, Vol.11, at 177–187.

  4. 4.

    N. Joyce et al. Mesenchymal stem cells for the treatment of neurodegenerative disease. Regen Med, 2010, Vol. 5, at 933–946.

  5. 5.

    B. Lo et al. A new era in the ethics of human embryonic stem cell research. Stem Cells, 2005, Vol. 23, at 1454–1459.

  6. 6.

    ED. Levens, AH. DeCherney. Human oocyte research: the ethics of donation and donor protection. JAMA, 2008, Vol. 300, at 2174–2176.

  7. 7.

    R. Jaenisch. Human cloning — the science and ethics of nuclear transplantation. N Engl J Med, 2004, Vol. 351, at 2787–2791.

  8. 8.

    B. Lo, A. Kriegstein, D. Grady. Clinical trials in stem cell transplantation: guidelines for scientific and ethical review. Clin Trials, 2008, Vol. 5, at 517–522.

  9. 9.

    L. Dawsonet al. Safety issues in cell-based intervention trials. Fertil Steril, 2003, Vol. 80, at 1077–1085.

  10. 10.

    〈http://www.eurostemcell.org/〉

  11. 11.

    B. Lo et al. Consent from donors for embryo and stem cell research. Science, 2003, Vol. 301, at 921.

  12. 12.

    R. Streiffer. Informed consent and federal funding for stem cell research. Hastings Cent Rep, 2008, Vol. 38, at 40–47.

  13. 13.

    C. Jopling et al. Dedifferentiation, transdifferentiation and reprogramming: three routes to regeneration. Nat Rev Mol Cell Biol, 2011, Vol. 12, at 79–89.

  14. 14.

    J. Aznar, JL. Sánchez. Embryonic stem cells: are useful in clinic treatments? J Physiol Biochem, 2011, Vol. 67, at 141–144.

  15. 15.

    P.Hematti. Human embryonic stem cell-derived mesenchymal progenitors: an overview. Methods Mol Biol, 2011, Vol. 690, at 163–174.

  16. 16.

    T. Vazin, WJ. Freed. Human embryonic stem cells: derivation, culture, and differentiation: a review. Restor Neurol Neurosci, 2010, Vol. 28, at 589–603.

  17. 17.

    〈http://georgewbush-whitehouse.archives.gov/dpc/stemcell/2007/index.html〉.

  18. 18.

    HE. Fadel. Developments in stem cell research and therapeutic cloning: islamic ethical positions, a review. Bioethics, 2010, Oct 6.

  19. 19.

    DI. Cryopreserved embryos in the United States and their availability for research. Fertil Steril, 2003, Vol. 79, at 1063–1069.

  20. 20.

    S. Sträm et al. No relationship between embryo morphology and successful derivation of human embryonic stem cell lines. PLoS One, 2010, Vol. 5, e15329.

  21. 21.

    X. Yang et al. Nuclear reprogramming of cloned embryos and its implications for therapeutic cloning. Nat Genet, 2007, Vol. 39, p. 295–302. Erratum in: Nat Genet, 2007, Vol. 39, at 1285.

  22. 22.

    VJ. Hall, M. Stojkovic. The status of human nuclear transfer. Stem Cell Rev, 2006, Vol. 2, at 301–308.

  23. 23.

    T. Amano et al. Nuclear transfer embryonic stem cells provide an in vitro culture model for Parkinson’s disease. Cloning Stem Cells, 2009, Vol. 11, at 77–88.

  24. 24.

    Commentary: Italian court sidesteps stem-cell challenge. Nature, 2009, Vol. 460, at 449.

  25. 25.

    A. Abbott. Italians sue over stem cells: Government’s exclusion of human embryonic cells from funding call sparks anger. Nature, 2009, Vol. 460, at 19.

  26. 26.

    R. Lewis. Stem Cells Come of Age. Insight Pharma Reports, June, 2011.

  27. 27.

    U. Karlsson, J. Hyllner, K. Runeberg. Trends in the human embryonic stem cell patent field. Recent Pat Nanotechnol, 2007, Vol. 1, at 233–237.

  28. 28.

    A. Abbott. Fresh hope for German stem-cell patent case: Referral to European Court may help to harmonize laws on intellectual property. Nature, 2009, Vol. 462, at 265.

  29. 29.

    A. Abbott. Stem-cell techique ‘contrary to public order’. Nature, 2006, Vol. 444, p. 799.

  30. 30.

    A. Abbott. German stem-cell law under fire. Nature, 2006, Vol. 444, at 253.

  31. 31.

    K. Takahashi et al. Induction of pluripotent stem cells from adult human fibroblasts by defined factors. Cell, 2007, Vol. 131, at 861–872.

  32. 32.

    IH. Park et al. Disease-specific induced pluripotent stem cells. Cell, 2008, Vol. 134, at 877–886.

  33. 33.

    J. Hanley et al. An introduction to induced pluripotent stem cells. Br J Haematol, 2010, Vol. 151, at 16–24.

  34. 34.

    J. Hanna et al. Treatment of sickle cell anaemia mouse model with iPS cells generated from autologous skin. Science, 2007, Vol. 318, at 1920–1923.

  35. 35.

    MT. Brown. Moral complicity in induced pluripotent stem cell research. Kennedy Inst Ethics J, 2009, Vol. 19, at 1–22.

  36. 36.

    NIH-NHLBI/NIDDK Thalassemia Workshop: Clinical Priorities and Clinical Trials. Fishers Lane Conference Center, 5635 Fishers Lane, Rockville, Maryland, May 20–21, 2009.

  37. 37.

    〈http://www.awapatent.dk/?id=15951〉

  38. 38.

    D. Cyranoski. Mice made from induced stem cells: Technical feat shows that the different route to stem cells can indeed make a full mammal body. Nature, 2009, Vol. 461, at 86–90.

  39. 39.

    XY. Zhao et al. iPS cells produce viable mice through tetraploid complementation. Nature, 2009, Vol. 461, at 86–90.

  40. 40.

    MJ. Boland et al. Adult mice generated from induced pluripotent stem cells. Nature, 2009, Vol. 461, at 91–94.

Abbreviations

ESC:

(embryonic stem cells)

hESC :

(human ESC)

iPS:

(induced pluripotent stem cells)

SCNT:

(somatic cell nuclear transfer)

IVF:

(in vitro fertilization)

EU:

(European Union)

References

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    Article  Google Scholar 

  2. AL. McGuireet al. Research ethics and the challenge of whole-genome sequencing. Nat Rev Genet, 2008, Vol. 9, at 152–156.

    Article  Google Scholar 

  3. A. Flynn, T. O’Brien. Stem cell therapy for cardiac disease. Expert Opin Biol Ther, 2011, Vol.11, at 177–187.

    Article  Google Scholar 

  4. N. Joyce et al. Mesenchymal stem cells for the treatment of neurodegenerative disease. Regen Med, 2010, Vol. 5, at 933–946.

    Article  Google Scholar 

  5. B. Lo et al. A new era in the ethics of human embryonic stem cell research. Stem Cells, 2005, Vol. 23, at 1454–1459.

    Article  Google Scholar 

  6. ED. Levens, AH. DeCherney. Human oocyte research: the ethics of donation and donor protection. JAMA, 2008, Vol. 300, at 2174–2176.

    Article  Google Scholar 

  7. R. Jaenisch. Human cloning — the science and ethics of nuclear transplantation. N Engl J Med, 2004, Vol. 351, at 2787–2791.

    Article  Google Scholar 

  8. B. Lo, A. Kriegstein, D. Grady. Clinical trials in stem cell transplantation: guidelines for scientific and ethical review. Clin Trials, 2008, Vol. 5, at 517–522.

    Article  Google Scholar 

  9. L. Dawsonet al. Safety issues in cell-based intervention trials. Fertil Steril, 2003, Vol. 80, at 1077–1085.

    Article  Google Scholar 

  10. B. Lo et al. Consent from donors for embryo and stem cell research. Science, 2003, Vol. 301, at 921.

    Article  Google Scholar 

  11. R. Streiffer. Informed consent and federal funding for stem cell research. Hastings Cent Rep, 2008, Vol. 38, at 40–47.

    Article  Google Scholar 

  12. C. Jopling et al. Dedifferentiation, transdifferentiation and reprogramming: three routes to regeneration. Nat Rev Mol Cell Biol, 2011, Vol. 12, at 79–89.

    Article  Google Scholar 

  13. J. Aznar, JL. Sánchez. Embryonic stem cells: are useful in clinic treatments? J Physiol Biochem, 2011, Vol. 67, at 141–144.

    Article  Google Scholar 

  14. P. Hematti. Human embryonic stem cell-derived mesenchymal progenitors: an overview. Methods Mol Biol, 2011, Vol. 690, at 163–174.

    Article  Google Scholar 

  15. T. Vazin, WJ. Freed. Human embryonic stem cells: derivation, culture, and differentiation: a review. Restor Neurol Neurosci, 2010, Vol. 28, at 589–603.

    Google Scholar 

  16. HE. Fadel. Developments in stem cell research and therapeutic cloning: islamic ethical positions, a review. Bioethics, 2010, Oct 6.

    Google Scholar 

  17. DI. Cryopreserved embryos in the United States and their availability for research. Fertil Steril, 2003, Vol. 79, at 1063–1069.

    Article  Google Scholar 

  18. S. Ström et al. No relationship between embryo morphology and successful derivation of human embryonic stem cell lines. PLoS One, 2010, Vol. 5, e15329.

    Article  Google Scholar 

  19. X. Yang et al. Nuclear reprogramming of cloned embryos and its implications for therapeutic cloning. Nat Genet, 2007, Vol. 39, p. 295–302. Erratum in: Nat Genet, 2007, Vol. 39, at 1285.

    Article  Google Scholar 

  20. VJ. Hall, M. Stojkovic. The status of human nuclear transfer. Stem Cell Rev, 2006, Vol. 2, at 301–308.

    Article  Google Scholar 

  21. T. Amano et al. Nuclear transfer embryonic stem cells provide an in vitro culture model for Parkinson’s disease. Cloning Stem Cells, 2009, Vol. 11, at 77–88.

    Article  Google Scholar 

  22. Commentary: Italian court sidesteps stem-cell challenge. Nature, 2009, Vol. 460, at 449.

    Google Scholar 

  23. A. Abbott. Italians sue over stem cells: Government’s exclusion of human embryonic cells from funding call sparks anger. Nature, 2009, Vol. 460, at 19.

    Article  Google Scholar 

  24. R. Lewis. Stem Cells Come of Age. Insight Pharma Reports, June, 2011.

    Google Scholar 

  25. U. Karlsson, J. Hyllner, K. Runeberg. Trends in the human embryonic stem cell patent field. Recent Pat Nanotechnol, 2007, Vol. 1, at 233–237.

    Article  Google Scholar 

  26. A. Abbott. Fresh hope for German stem-cell patent case: Referral to European Court may help to harmonize laws on intellectual property. Nature, 2009, Vol. 462, at 265.

    Article  Google Scholar 

  27. A. Abbott. Stem-cell techique ‘contrary to public order’. Nature, 2006, Vol. 444, p. 799.

    Article  Google Scholar 

  28. A. Abbott. German stem-cell law under fire. Nature, 2006, Vol. 444, at 253.

    Article  Google Scholar 

  29. K. Takahashi et al. Induction of pluripotent stem cells from adult human fibroblasts by defined factors. Cell, 2007, Vol. 131, at 861–872.

    Article  Google Scholar 

  30. IH. Park et al. Disease-specific induced pluripotent stem cells. Cell, 2008, Vol. 134, at 877–886.

    Article  Google Scholar 

  31. J. Hanley et al. An introduction to induced pluripotent stem cells. Br J Haematol, 2010, Vol. 151, at 16–24.

    Article  Google Scholar 

  32. J. Hanna et al. Treatment of sickle cell anaemia mouse model with iPS cells generated from autologous skin. Science, 2007, Vol. 318, at 1920–1923.

    Article  Google Scholar 

  33. MT. Brown. Moral complicity in induced pluripotent stem cell research. Kennedy Inst Ethics J, 2009, Vol. 19, at 1–22.

    Article  Google Scholar 

  34. D. Cyranoski. Mice made from induced stem cells: Technical feat shows that the different route to stem cells can indeed make a full mammal body. Nature, 2009, Vol. 461, at 86–90.

    Article  Google Scholar 

  35. XY. Zhao et al. iPS cells produce viable mice through tetraploid complementation. Nature, 2009, Vol. 461, at 86–90.

    Article  Google Scholar 

  36. MJ. Boland et al. Adult mice generated from induced pluripotent stem cells. Nature, 2009, Vol. 461, at 91–94.

    Article  Google Scholar 

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Author information

Authors and Affiliations

  1. University of Ferrara, Italy

    Roberto Gambari (Professor of Biochemistry) & Alessia Finotti (Post-doctoral Researcher)

Authors
  1. Roberto Gambari
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  2. Alessia Finotti
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Editor information

Editors and Affiliations

  1. Department of Juridical Sciences, University of Ferrara, Italy

    Roberto Bin , Sara Lorenzon  & Nicola Lucchi ,  & 

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Gambari, R., Finotti, A. (2012). Bioethics and Freedom of Scientific Research in Gene Therapy and Stem Cell Biology. In: Bin, R., Lorenzon, S., Lucchi, N. (eds) Biotech Innovations and Fundamental Rights. Springer, Milano. https://doi.org/10.1007/978-88-470-2032-0_9

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