stem cell therapy ethics and concern in modern times

stem cell therapy ethics and concern in modern times

1. Ethics & Stem Cell Therapy in Regenerative Medicine: Challenges & Opportunities Group 10

2. 1. Background 2

3. 67.4 billion $ (2030) 4.29 billion $ 16.1 billion $ (2020) 3 The hype for the stem cell therapy

4. A New Hope From Autoimmune Disease to Spinal Cord Injury 4

5. Embryonic stem cell Induced pluripotent stem cells 5 Stem Cell Therapy Requires the Sacrifice of Embryos…

6. Stem cell Banks Stem Cell Banks 6 For storage of placental stem cells after birth of a child.

7. Ethical Issues in Stem Cell Technology - Outline Ethical Issues in Stem Cell Banking Ethical Issues in Ownership of Stem Cells & Law & Regulation Opportunity What Stem cell therapy is for & Benefits of Stem Cell Therapy Ethical Issues for Sacrificing Stem Cells Embryonic Stem Cell vs humans & Induced pluripotent stem cells (iPS) 7 Conclusion, Solutions, Search Method The Legal, Governmental, Educational Solutions & Research Methodology

8. 2. Opportunities 8

9. Regenerative Medicine - opportunity Seeks to replace tissue or organs that have been damaged by disease, trauma, or congenital issues Current clinical strategy focuses primarily on treating the symptoms

10. Stem Cell Therapy Stem cell therapy about cardiovascular disease

11. Usages of different types of stem cells Success in various clinical applications Can generate most cell types Can be used for learning human development Useful for drug development and developmental studies Abundant somatic cells can be used, can be reprogrammed Adult stem cells Embryonic stem cells Induced pluripotent stem cells 11

12. 3. Stem Cell - are they human? 12

13. Ethical Standards for Human Subject in Research “No experiment should be conducted where there is an a priori reason to believe that death or disabling injury will occur; except, perhaps, in those experiments where the experimental physicians also serve as subjects” “Respect for persons incorporates at least two ethical convictions: first, that individuals should be treated as autonomous agents, and second, that persons with diminished autonomy are entitled to protection.” Nuremberg Code (1947) Belmont Report (1974)

14. Are Embryonic Stem Cells Human? Just a Type of Cell Human VS

15. Potential to develop as an individual human… what about pluripotent stem cells Human? Skin Cell IPSC Human

16. Solution - 14th day rule

17. 4. Ethical, Legal, & Social Analysis of Ethical Issues for Stem Cell Banking 17

18. Biopreservation - ELS Challenges Ethical Ownership Informed consent Legal Unclear regulation Legal Right to ownership Society Market Transparency Pubic understanding 18

19. 1. Ethical Challenges Stem Cell in the bank 👉 Ownership ? Henrietta Lacks HeLa Cells were used in worldwide without her consent Informed consent Can the child withdraw the cells when he/she grown up? 19

20. 2. Legal Challenges Regulation not well-established Government 👉 Reinforce the law Caregivers/patients 👉 Speed up the therapy process Inherent legal right to ownership 20

21. 3. Society Challenges Lack of market transparency Misleading & Oversell marketing Low-level knowledge of customers Therapeutic misestimation 21

22. 5. Proposed Solutions 22

23. Some of the existing regulations US&UK:14-day law US:Food and Drug Administration(FDA) Japan:Multiple laws passed to regulate -Law based regulation China:Rely on paper review or guidelines -Ethical based regulation

24. Solution 1 legal regulations Laws to ban the use of misleading terms Define what cells are allowed for various purposes Safeguard the right of public 24

25. Solutions 2 education Educate general public -Basics of regenerative medicine Educate professionals -Remind the taboos 25

26. Solutions 3 government regulations Setup certification body -Investigational New Drug (IND) Application Aids for the regenerative medicine 26

27. 6. Conclusion 27

28. Conclusion A market filled with great market size and novel ways to cure and hope The ethical issue brought by regenerative medicine need to be solved under the cooperation of different parties

29. Search Method: 29 Collecting data: PubMed, UST Library Power Search, Google Scholar, Statista, HHS.gov, ASPEN Journals Reading review papers for a comprehensive view -For general understanding

30. Q&A Section

31. Reference list Peng, Y.-J., Huang, X., & Zhou, Q. (2020). Ethical and policy considerations for human embryo and stem cell research in China. Cell Stem Cell, 27(4), 511–514. https://doi.org/10.1016/j.stem.2020.09.010 Hara, A., Sato, D., & Sahara, Y. (2014). New governmental regulatory system for stem cell—based therapies in Japan. Therapeutic Innovation & Regulatory Science, 48(6), 681–688. https://doi.org/10.1177/2168479014526877 Yui, H., Muto, K., Yashiro, Y., Watanabe, S., Kiya, Y., Kamisato, A., Inoue, Y., & Yamagata, Z. (2022). Comparison of the 2021 International Society for Stem Cell Research (ISSCR) guidelines for “laboratory-based human stem cell research, embryo research, and related research activities” and the corresponding Japanese regulations. Regenerative Therapy, 21, 46–51. https://doi.org/10.1016/j.reth.2022.05.002 Aly, R. M. (2020). Current state of stem cell-based therapies: An overview. Stem Cell Investigation, 7, 8–8. https://doi.org/10.21037/sci-2020-001 Center for Drug Evaluation and Research. (n.d.). Investigational New Drug (IND) Application. U.S. Food and Drug Administration. Retrieved November 9, 2022, from https://www.fda.gov/drugs/types-applications/investigational-new-drug-ind-application Day, J. A. (2022, February 18). Upholding the highest bioethical standards: Johns Hopkins Medicine. Upholding the Highest Bioethical Standards | Johns Hopkins Medicine. Retrieved November 9, 2022, from https://www.hopkinsmedicine.org/henriettalacks/upholding-the-highest-bioethical-standards.html

32. moye, L. A. (2015, July 1). Effectiveness of stem cell treatment for adults with ischemic cardiomyopathy (the focus study) - full text view . Full Text View - ClinicalTrials.gov. Retrieved November 9, 2022, from https://www.clinicaltrials.gov/ct2/show/study/NCT00824005?term=stem%2Bcell&cond=Heart%2BDiseases&cntry=US&draw=2&rank=8 University of Nebraska Medical Center. (n.d.). Pros and cons: Stem cells: University of Nebraska Medical Center . UNMC. Retrieved November 9, 2022, from https://www.unmc.edu/stemcells/educational-resources/prosandcons.html University of Pittsburgh. (2022, May 27). What is regenerative medicine? Regenerative Medicine at the McGowan Institute. Retrieved November 9, 2022, from https://mirm-pitt.net/about-us/what-is-regenerative-medicine/ Elena Salvaterra. (2006). The ethics of cord blood banking in light of ownership, informed ... Retrieved November 9, 2022, from https://www.researchgate.net/publication/232274081_The_Ethics_of_Cord_Blood_Banking_in_Light_of_Ownership_Informed_Consent_and_Solidarity Kuen, Patrick Foong Chee (2019). Ownership issues in autologous stem cell therapies. Eubios Journal of Asian and International Bioethics 29 (6):186-190. Murdoch, B., Marcon, A. R., & Caulfield, T. (2020, July 1). The law and problematic marketing by private umbilical cord blood banks - BMC Medical Ethics . BioMed Central. Retrieved November 9, 2022, from https://bmcmedethics.biomedcentral.com/articles/10.1186/s12910-020-00494-2