Presentation for conference on stems cells

1. Dias 1
Use of Human Stem Cells: What
are the Ethical Issues?
T.J. Kasperbauer and Peter Sandøe
Department of Large Animal Sciences
Department of Food and Resource Economics
University of Copenhagen

2. PLAN
1. Embryos to iPSCs
2. Privacy and Consent
3. Risks in Stem Cell Therapy
4. Therapy and Enhancement

3. EARLY DEBATES
Intrinsically Wrong
• Playing God
• Unnatural

4. EARLY DEBATES
Moral Status of Embryos
• Human embryos have the potential to become humans
• But when does this matter? And why?
• 5-7 day old blastocyst—sufficiently human?
Potentiality Argument

5. EARLY DEBATES
These debates have been largely laid to rest
• Not clear why unnatural=wrong
• No reasonable basis for potentiality argument
• Early use of embryos avoids many difficult questions
about moral status

6. Percentage of U.S. adults by partisanship who favor embryonic stem cell research,
2002–2010.
Nisbet M, Markowitz EM (2014) Understanding Public Opinion in Debates over Biomedical Research: Looking
beyond Political Partisanship to Focus on Beliefs about Science and Society. PLoS ONE 9(2): e88473.
doi:10.1371/journal.pone.0088473
http://127.0.0.1:8081/plosone/article?id=info:doi/10.1371/journal.pone.0088473

7. Sted og dato Enhedens navn Dias 7

8. EMBRYOS TO IPSCS
Some of the same issues
• The Extension Argument (Annis 1984)
Anything with the potential to become an adult human being
should be treated as having the same moral status as an adult
human being.
• But would be odd to treat somatic cells like adult
human beings

9. EMBRYOS TO IPSCS
Biobanking
• Storage of biological material has sharpened focus on
privacy of donors and patients
• Also raises questions about consent

10. STEM CELL RESEARCH
Privacy
• With genetic analysis, all information is
pseudoanonymous
- Gymrek, McGuire, Golan, Halperin, Erlich (2013), “Identifying
Personal Genomes by Surname Inference.” Science
• Widely shared databases may put personal information
at risk
• New EU laws may restrict data sharing
- Amendments to Data Protection Regulation (possibly 2015)

11. STEM CELL RESEARCH
Types of Privacy
• Informational Privacy (restricting access)
- e.g., genetic discrimination, 3rd party access
• Decisional Privacy (autonomy in choice)
- e.g., info about diseases, informing family members
• Physical Privacy (restricting collection and storage)
- e.g., records, biobanks, inspection and observation
• Proprietary Privacy (controlling financial gain)
- e.g., cell lines, property rights

12. Oliver, Slashinski, Wang, Kelly, Hilsenbeck, McGuire (2012)

13. STEM CELL RESEARCH
Consent
• Broad: consent to general, and often undetermined, uses of
personal data and biological material
• Narrow: consent to specific uses of personal data and biological
material (e.g., a single study)
• Tiered: consent to multiple different uses of data and biological
material, as specified by the individual
• Dynamic: recurring requests for consent for different uses of
personal data and biological material

14. STEM CELL RESEARCH
Consent
• Broad: consent to general, and often undetermined,
uses of personal data and biological material
• But is this really informed consent?
- Broad consent seems more like authorization than consent.
Doctors and researchers don’t really know what will happen
with patients’ data once it is shared in large databases

15. Articles
• Hug, K., Hermerén, G., & Johansson, M. (2012). Withdrawal from
biobank research: considerations and the way forward. Stem Cell
Reviews, 8, 1056–1065.
• Isasi, R. et al. (2014). Identifiability and privacy in pluripotent stem cell
research. Cell Stem Cell, 14, 427–430.
• Knoppers, B. M. & Isasi,, R. (2010). Stem cell banking: Between
traceability and identifiability. Genome Medicine, 2, 73.
• Lomax, G. P., Hull, S. C., Lowenthal, J., Rao, M., & Isasi, R. (2013). The
DISCUSS Project: induced pluripotent stem cell lines from previously
collected research biospecimens and informed consent: points to
consider. Stem Cell Translational Medicine, 2, 727-730.
• Lomax, G. P., & Shepard, K. A. (2013). Return of results in translational
iPS cell research: considerations for donor informed consent. Stem Cell
Research & Therapy, 4, 6–7.
• Lowenthal, J. et al. (2012). Specimen collection for induced pluripotent
stem cell research: Harmonizing the approach to informed consent. Stem
Cells Translational Medicine, 1, 409-421.
• Walker, T. (2013). Respecting autonomy without disclosing information.
Bioethics, 27, 388-294.

16. RISKS IN STEM CELL THERAPY
Medical Risks
• Tumoricity
• Rejection

17. RISKS IN STEM CELL THERAPY
Risk Perception
• Therapeutic misconception
• Exaggerated benefits, downplayed risks
• Stem cell tourism

18. Sted og dato Dias 18
Lau et al. (2008). Stem Cell
Clinics Online: The Direct-
to-Consumer Portrayal of
Stem Cell Medicine

19. Sted og dato
Dias 19
Kamenova et al. (2014). Representations
of stem cell clinics on Twitter.

20. RISKS IN STEM CELL THERAPY
Risk Communication
• Patients must be told about risks, realistic benefits
• Patient concerns may not correspond with concerns of
doctors and researchers

21. Articles
• Barker, R. A. & de Beaufort, I. (2013). Scientific and ethical issues
related to stem cell research and interventions in neurodegenerative
disorders of the brain. Progress in Neurobiology, 110, 63-73.
• Dimmeler, S., Ding, S., Rando, T. A., & Trounson, A. (2014).
Translational strategies in regenerative medicine. Nature Medicine, 20,
814-821.
• Fung, R. K. F., & Kerridge, I. H. (2013). Uncertrain translation, uncertain
benefit and uncertain risk. Bioethics, 27, 89-96.
• Lau et al. (2008). Stem cell clinics online: the direct-to-consumer
portrayal of stem cell medicine. Cell Stem Cell, 3, 591–594.
• Lowry, W. E., & Quan, W. L. (2010). Roadblocks en route to the clinical
application of induced pluripotent stem cells. Journal of Cell Science,
123, 643-651.
• Munsie, M. & Hyun, I. (2014). A question of ethics: Selling autologous
stem cell therapies flaunts professional standards. Stem Cell Research,
13, 647-653.

22. THERAPY VS. ENHANCEMENT
Is it really stem cell therapy?
• There are many things we do to enhance ourselves
that we think of as necessary for human well-being
- e.g., medicine, nutrition, education
• Some uses of stem cells seem less like medicine and
more like gene editing (non-heritable)
• Is this problematic?

23. Dias 23

24. THERAPY VS. ENHANCEMENT
Comparison to CRISPR
• Both could treat serious and debilitating diseases
• Whether it is therapy or enhancement does not seem
to make a moral difference
• Equal access is important