Advertisement

Ethical Aspects of Stem Cell-Based Clinical Translation: Research, Innovation,and Delivering Unproven Interventions

  • Jeremy Sugarman
  • Douglas Sipp
Part of the Stem Cell Biology and Regenerative Medicine book series (STEMCELL)

Abstract

The clinical translation of human pluripotent stem cells may take several different paths including clinical translational research, medical innovation, and the clinical use of untested or unproven interventions. Each of these translational pathways operates within particular ethical frameworks. These frameworks include distinct standards of practice and procedural mechanisms for addressing the ethical issues inherent to each pathway. As such, it is essential that these differences be recognized to best protect not only the well-being of patients, but also of the scientific enterprise as it seeks to understand the true value of stem-cell based interventions.

Keywords

Clinical trials Ethics Research ethics Stem cell therapies Stem cell treatment 

References

  1. 1.
    Leite M. Stem cell research in Brazil: a difficult launch. Cell 2006; 124:1107–9.PubMedCrossRefGoogle Scholar
  2. 2.
    Fujikawa T, Oh S-H, Pi L, Hatch H, Shupe T, Petersen B. Teratoma formation leads to failure of treatment for type I diabetes using embryonic stem cell-derived insulin-producing cells. Am J Pathol. 2005; 166:1781–91.PubMedCrossRefGoogle Scholar
  3. 3.
    Darabi R, Gehlbach K, Bachoo R, Kamath S, Osawa M, Kamm K et al. Functional skeletal muscle regeneration from differentiating embryonic stem cells. Nat Med. 2008; 14:134–43.PubMedCrossRefGoogle Scholar
  4. 4.
    Takahashi K, Yamanaka S. Induction of pluripotent stem cells from mouse embryonic and adult fibroblast cultures by defined factors. Cell 2006; 126:663–76.PubMedCrossRefGoogle Scholar
  5. 5.
    Yamanaka S. A fresh look at iPS cells. Cell 2009; 137:13–7.PubMedCrossRefGoogle Scholar
  6. 6.
    Greaves MF. Cord blood donor cell leukemia in recipients. Leukemia 2006; 20:1633–4.PubMedCrossRefGoogle Scholar
  7. 7.
    Avital I, Moreira AL, Klimstra DS, Leversha M, Papadopoulos EB. Donor-derived human bone marrow cells contribute to solid organ cancers developing after bone marrow transplantation. Stem Cells 2007; 25:2903–9.PubMedCrossRefGoogle Scholar
  8. 8.
    International Society for Stem Cell Research. Guidelines for the clinical translation of stem cells. December 3, 2008. Available at: http://www.isscr.org/clinical_trans.
  9. 9.
    World Medical Association. Declaration of Helsinki, 2008. Available at: http://www.wma.net/en/30publications/10policies/b3/index.html.
  10. 10.
    International Council on Harmonization. Guidelines. May 1996. Available at: http://www.ich.org/cache/compo/276-254-1.html.
  11. 11.
    National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. Belmont report, 1979. Available at: http://ohsr.od.nih.gov/guidelines/belmont.html.
  12. 12.
    Biffl WL, Spain DA, Reitsma AM, Minter RM, Upperman J, Wilson M et al. Responsible development and application of surgical innovations: a position statement of the Society of University Surgeons. J Am Coll Surg. 2008; 206:1204–9.PubMedCrossRefGoogle Scholar
  13. 13.
    Gluckman E, Broxmeyer HA, Auerbach AD, Friedman HS, Douglas GW, Devergie A et al. Hematopoietic reconstitution in a patient with Fanconi’s anemia by means of umbilical-cord blood from an HLA-identical sibling. N Engl J Med. 1989; 321:1174–8.PubMedCrossRefGoogle Scholar
  14. 14.
    Wagner JE, Kernan NA, Steinbuch M, Broxmeyer HE, Glockman E. Allogeneic sibling umbilical-cord-blood transplantation in children with malignant and non-malignant disease. Lancet 1995; 346:214–9.PubMedCrossRefGoogle Scholar
  15. 15.
    Kurtzberg J, Lyerly AD, Sugarman J. Untying the Gordian knot: policies, practices, and ­ethical issues related to banking of umbilical cord blood. J Clin Invest. 2005; 115:2592–7.PubMedCrossRefGoogle Scholar
  16. 16.
    Lyerly AD, Gates EA, Cefalo RC, Sugarman J. Towards the ethical evaluation and use of maternal-fetal surgery. Obstet Gynecol. 2001; 98:689–97.PubMedCrossRefGoogle Scholar
  17. 17.
    Cronin DC, Millis JM, Siegler M. Transplantation of liver grafts from living donors into adults – too much, too soon. New Engl J Med. 2001; 344:1633–7.PubMedCrossRefGoogle Scholar
  18. 18.
    Rettig RA, Jacobson PD, Farquhar CM, Aubry WM. False hope: bone marrow transplantation for breast cancer. New York: Oxford University Press, 2007.Google Scholar
  19. 19.
    Lindvall O, Hyun I. Medical innovation versus stem cell tourism. Science 2009; 324:1664–5.PubMedCrossRefGoogle Scholar
  20. 20.
    Agich GJ. Ethics and innovation in medicine. J Med Ethics 2001; 27:295–6.PubMedCrossRefGoogle Scholar
  21. 21.
    Ehrbeck T, Guevara C, Mango PD. Mapping the market for medical travel. The McKinsey Quarterly 2008. Available at: www.mckinseyquarterly.com/.../Mapping_the_market_for_travel_2134.
  22. 22.
    Deloitte Center for Health Solutions. Medical tourism: consumers in search of value. Deloitte 2008. Available at: www.deloitte.com/dtt/cda/doc/.../us_chs_MedicalTourismStudy(1).pdf.
  23. 23.
    Kiatpongsan S, Sipp D. Monitoring and regulating offshore stem cell clinics. Science 2009; 323:1564–5.PubMedCrossRefGoogle Scholar
  24. 24.
    Lau D, Ogbogu U, Taylor B, Stafinski T, Menon D, Caulfield T. Stem cell clinics online: the direct-to-consumer portrayal of stem cell medicine. Cell Stem Cell 2008; 3:591–4.PubMedCrossRefGoogle Scholar
  25. 25.
    Fleischauer K, Hermerén G. Goals of medicine in the course of history and today: a study in the history and philosophy of medicine. Stockholm: Kungl, 2006.Google Scholar

Additional Websites Referenced

  1. ALS Worldwide: www.alsworldwide.org
  2. Beike Biotechnology: www.beikebiotech.com
  3. Geron Corp.: http://www.geron.com
  4. International Cellular Medicine Society (ICMS): http://www.stemcelldocs.org
  5. Juvenile Diabetes Research Fund: www.jdrf.org
  6. Neuralstem Inc.: http://www.neuralstem.com
  7. Osiris Therapeutics Inc.: http://www.osiristx.com

Copyright information

© Springer Science+Business Media, LLC 2011

Authors and Affiliations

  • Jeremy Sugarman
    • 1
  • Douglas Sipp
  1. 1.Department of MedicineBerman Institute of BioethicsBaltimoreUSA

Personalised recommendations