Cited by 267Biomedical Ethics and RegulationEthics in Clinical ResearchEthics and bioethics in healthcare

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Ethical issues in stem cell research and therapy

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King, Nancy MP, Perrin, Jacob·2014·Stem Cell Research & Therapy

Abstract

Rapid progress in biotechnology has introduced a host of pressing ethical and policy issues pertaining to stem cell research. In this review, we provide an overview of the most significant issues with which the stem cell research community should be familiar. We draw on a sample of the bioethics and scientific literatures to address issues that are specific to stem cell research and therapy, as well as issues that are important for stem cell research and therapy but also for translational research in related fields, and issues that apply to all clinical research and therapy. Although debate about the moral status of the embryo in human embryonic stem cell research continues to have relevance, the discovery of other highly multipotent stem cell types and alternative methods of isolating and creating highly multipotent stem cells has raised new questions and concerns. Induced pluripotent stem cells hold great promise, but care is needed to ensure their safety in translational clinical trials, despite the temptation to move quickly from bench to bedside. A variety of highly multipotent stem cells - such as mesenchymal stem/stromal cells and stem cells derived from amniotic fluid, umbilical cord blood, adipose tissue, or urine - present the opportunity for widespread biobanking and increased access. With these increased opportunities, however, come pressing policy issues of consent, control, and justice. The imperatives to minimize risks of harm, obtain informed consent, reduce the likelihood of the therapeutic misconception, and facilitate sound translation from bench to bedside are not unique to stem cell research; their application to stem cell research and therapy nonetheless merits particular attention. Because stem cell research is both scientifically promising and ethically challenging, both the application of existing ethical frameworks and careful consideration of new ethical implications are necessary as this broad and diverse field moves forward.

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  • High costs and ethical concerns remain barriers to widespread adoption of MSC therapies.

    “MSC therapies demonstrated cartilage regeneration and early osteoarthritis improvement, but high costs and ethical concerns remain barriers to widespread adoption.”

    From Advancements in Regenerative Therapies for Orthopedics: A Comprehensive Review of Platelet-Rich Plasma, Mesenchymal Stem Cells, Peptide Therapies, and Biomimetic Applications (2025) · cites this paper as [22]

    The “Justice in stem cell research and treatment” section says cell-based therapies can be extraordinarily costly and that costs affect access; it also discusses ethical challenges in making stem cell therapies available. It does not establish that these are barriers to widespread adoption of MSC therapies specifically. Page numbers were not provided in our copy. (LLM, conf=0.85)

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Research works printed but not linked: 51

  1. Lo B, Parham L: Resolving ethical issues in stem cell clinical trials: the example of Parkinson disease. J Law Med Ethics. 2010, 38: 257-266. 10.1111/j.1748-720X.2010.00486.x. · DOI
  2. Habets MG, van Delden JJ, Bredenoord AL: The inherent ethical challenge of first-in-human pluripotent stem cell trials. Regen Med. 2014, 9: 1-3. 10.2217/rme.13.83. · DOI
  3. Niemansburg SL, Teraa M, Hesam H, van Delden JJ, Verhaar MC, Bredenoord AL: Stem cell trials for cardiovascular medicine: ethical rationale. Tiss Eng Part A. 2013, [Epub ahead of print]
  4. Levine R: Ethics and Regulation of Clinical Research. 1988, New York: Yale University Press
  5. Gilbert S, Kaebnick GE, Murray TH: Special Report: Animal research ethics: evolving views and practices. Hastings Center Rep. 2012, 42: S1-S39. · DOI
  6. Joffe S, Miller FG: Bench to bedside: mapping the moral terrain of clinical research. Hastings Center Rep. 2008, 38: 30-42. · DOI · Paper page
  7. Arcidiacono JA, Blair JW, Benton KA: US Food and Drug Administration international collaborations for cellular therapy product regulation. Stem Cell Res Ther. 2012, 3: 38-42. 10.1186/scrt129. · DOI
  8. Caulfield T, Zarzeczny A, McCormick J, Bubela T, Critchley C, Einsiedel E, Galipeau J, Harmon S, Huynh M, Hyun I, Illes J, Isasi R, Joly Y, Laurie G, Lomax G, Longstaff H, McDonald M, Murdoch C, Ogbogu U, Owen-Smith J, Pattinson S, Premji S, von Tigerstrom B, Winickoff DE: The stem cell research environment: a patchwork of patchworks. Stem Cell Rev. 2009, 5: 82-88. 10.1007/s12015-009-9071-3. · DOI
  9. Greely H: Assessing ESCROs: yesterday and tomorrow. Am J Bioeth. 2013, 13: 44-52. · DOI
  10. Lomax GP, Peckman SR: Stem cell policy exceptionalism: proceed with caution. Stem Cell Rev Rep. 2012, 8: 299-304. 10.1007/s12015-011-9305-z. · DOI
  11. Hyun I, Lindvall O, Ahrlund-Richter L, Cattaneo E, Cavazzana-Calvo M, Cossu G, De Luca M, Fox IJ, Gerstle C, Goldstein RA, Hermeren G, High KA, Kim HO, Lee HP, Levy-Lahad E, Li L, Lo B, Marshak DR, McNab A, Munsie M, Nakauchi H, Rao M, Rooke HM, Valles CS, Srivastava A, Sugarman J, Taylor PL, Veiga A, Wong AL, Zoloth L, Daley GQ: New ISSCR guidelines underscore major principles for responsible translational stem cell research. Cell Stem Cell. 2008, 3: 607-609. 10.1016/j.stem.2008.11.009. · DOI
  12. Caulfield T: Stem cell research and economic promises. J Law Med Ethics. 2010, 38: 303-313. 10.1111/j.1748-720X.2010.00490.x. · DOI
  13. Caulfield T, Rachul C, Zarzeczny A: The evolution of policy issues in stem cell research: an international survey. Stem Cell Rev Rep. 2012, 8: 1037-1042. 10.1007/s12015-012-9404-5. · DOI
  14. Emanuel EJ, Wendler D, Grady C: What makes clinical research ethical?. JAMA. 2000, 283: 2701-2711. 10.1001/jama.283.20.2701. · DOI · Paper page
  15. Kato K, Kimmelman J, Robert J, Sipp D, Sugarman J: Ethical and policy issues in the clinical translation of stem cells: report of a focus session at the ISSCR annual meeting. Cell Stem Cell. 2012, 11: 765-767. 10.1016/j.stem.2012.11.004. · DOI
  16. London AJ, Kimmelman J, Emborg ME: Beyond access vs. protection in trials of innovative therapies. Science. 2010, 328: 829-830. 10.1126/science.1189369. · DOI
  17. King NM, Cohen-Haguenauer O: En route to ethical recommendations for gene transfer clinical trials. Mol Ther. 2008, 16: 432-438. 10.1038/mt.2008.13. · DOI
  18. Dresser R: First-in-human trial participants: not a vulnerable population, but vulnerable nonetheless. J Law Med Ethics. 2009, 37: 38-50. · DOI
  19. Dresser R: Stem cell research as innovation: expanding the ethical and policy conversation. J Law Med Ethics. 2010, 38: 332-341. 10.1111/j.1748-720X.2010.00492.x. · DOI
  20. Dresser R: Alive and well: the research imperative. J Law Med Ethics. 2012, 40: 915-921. · DOI
  21. Dresser R: The ubiquity and utility of the therapeutic misconception. Soc Philos Policy. 2002, 19: 271-294. 10.1017/S0265052502192119. · DOI
  22. King NM, Henderson GE, Churchill LR, Davis AM, Hull SC, Nelson DK, Parham-Vetter PC, Rothschild BB, Easter MM, Wilfond BS: Consent forms and the therapeutic misconception: the example of gene transfer research. IRB. 2005, 27: 1- · DOI
  23. Hyun I: The bioethics of stem cell research and therapy. J Clin Invest. 2010, 120: 71-75. 10.1172/JCI40435. · DOI
  24. Daley GQ: The promise and perils of stem cell therapeutics. Cell Stem Cell. 2012, 10: 740-749. 10.1016/j.stem.2012.05.010. · DOI
  25. Sugarman J: Human stem cell ethics: beyond the embryo. Cell Stem Cell. 2008, 2: 529-533. 10.1016/j.stem.2008.05.005. · DOI
  26. Sipp D: Direct-to-consumer stem cell marketing and regulatory responses. Stem Cells Translational Med. 2013, 2: 638-640. 10.5966/sctm.2013-0040. · DOI
  27. Weissman I: Stem cell therapies could change medicine if they get the chance. Cell Stem Cell. 2012, 10: 663-665. 10.1016/j.stem.2012.05.014. · DOI
  28. Hyun I, Hochedlinger K, Jaenish R, Yamanaka S: New advances in iPS cell research do not obviate the need for human embryonic stem cells. Cell Stem Cell. 2007, 4: 367-368. · DOI
  29. King NM, Coughlin CN, Atala A: Pluripotent stem cells: the search for the ‘perfect’ source. Minn J Law Sci Technol. 2011, 12: 715-730.
  30. Ishii T, Pera RA, Greely HT: Ethical and legal issues arising in research on inducing human germ cells from pluripotent stem cells. Cell Stem Cell. 2013, 13: 145-148. 10.1016/j.stem.2013.07.005. · DOI
  31. Cohen CB: Renewing the Stuff of Life: Stem Cells, Ethics, and Public Policy. 2007, New York: Oxford University Press · DOI
  32. Human Embryonic Stem Cell Research Advisory Committee, The National Academies: Final Report and 2010 Amendments to the National Academies’ Guidelines for Human Embryonic Stem Cell Research. 2010, Washington, DC: National Academies Press
  33. Yamanaka S: Induced pluripotent stem cells: past, present, and future. Cell Stem Cell. 2012, 10: 678-684. 10.1016/j.stem.2012.05.005. · DOI
  34. Pera MF: Stem cells: the dark side of induced pluripotency. Nature. 2011, 471: 46-47. 10.1038/471046a. · DOI
  35. Obokata H, Wakayama T, Sasai Y, Kojima K, Vacanti MP, Niwa H, Yamato M, Vacanti CA: Stimulus-triggered fate conversion of somatic cells into pluripotency. Nature. 2014, 505: 641-647. 10.1038/nature12968. · DOI
  36. Cyranoski D: Acid bath offers easy path to stem cells. Nature. 2014, 505: 596-10.1038/505596a. · DOI
  37. Cyranoski D: Acid-bath stem-cell study under investigation. Nature. 2014, [http://www.nature.com/news/acid-bath-stem-cell-study-under-investigation-1.14738]
  38. Kimmelman J, Baylis F, Glass KG: Stem cell trials: lessons from gene transfer research. Hastings Cent Rep. 2006, 36: 23-26. · DOI
  39. Hyun I: Allowing innovative stem cell based therapies outside of clinical trials: ethical and policy challenges. J Law Med Ethics. 2010, 38: 277-285. 10.1111/j.1748-720X.2010.00488.x. · DOI
  40. Wilson JM: A history lesson for stem cells. Science. 2009, 324: 727-728. 10.1126/science.1174935. · DOI
  41. Bretzner F, Gilbert F, Baylis F, Brownstone RM: Target populations for first-in-human embryonic stem cell research in spinal cords. Cell Stem Cell. 2011, 8: 468-475. 10.1016/j.stem.2011.04.012. · DOI
  42. Lukovic D, Stojkovic M, Moreno-Manzano V, Bhattacharya SS, Erceg S: Perspectives and future directions of human pluripotent stem cell-based therapies: lessons from Geron’s clinical trial for spinal cord injury. Stem Cells Dev. 2014, 23: 1-4. 10.1089/scd.2013.0266. · DOI
  43. Illes J, Reimer C, Kwon BK: Stem cell clinical trials for spinal cord injury: readiness, reluctance, redefinition. Stem Cell Rev. 2011, 7: 997-1005. 10.1007/s12015-011-9259-1. · DOI
  44. Esch MB, King TL, Shuler ML: The role of body-on-a-chip devices in drug and toxicity studies. Ann Rev Biomed Eng. 2011, 13: 55-72. 10.1146/annurev-bioeng-071910-124629. · DOI
  45. Lowenthal J, Lipnick S, Rao M, Hull SC: Specimen collection for induced pluripotent stem cell research: harmonizing the approach to informed consent. Stem Cells Translational Med. 2012, 1: 409-421. 10.5966/sctm.2012-0029. · DOI
  46. Lomax GP, Hull SC, Lowenthal J, Rao M, Isasi R: The DISCUSS project: induced pluripotent stem cell lines from previously collected research biospecimens and informed consent: points to consider. Stem Cells Translational Med. 2013, 2: 727-730. 10.5966/sctm.2013-0099. · DOI
  47. Lomax GP, Shepard KA: Return of results in translational iPS cell research: considerations for donor informed consent. Stem Cell Res Ther. 2013, 4: 6-7. 10.1186/scrt154. · DOI
  48. Hyun I: The bioethics of iPS cell based drug discovery. Clin Pharmacol Ther. 2011, 89: 646-647. 10.1038/clpt.2010.308. · DOI
  49. King NM, Coughlin CN, Furth M: Ethical issues in regenerative medicine. Wake Forest Intellectual Property Law J. 2009, 9: 216-238.
  50. Faden RR, Dawson L, Bateman-House AS, Agnew DM, Bok H, Brock DW, Chakravarti A, Gao XJ, Greene M, Hansen JA, King PA, O’Brien SJ, Sachs DH, Schill KE, Siegel A, Solter D, Suter SM, Verfaillie CM, Walters LB, Gearhart JD: Public stem cell banks: considerations of justice in stem cell research and therapy. Hastings Center Rep. 2003, 33: 13-27. · DOI
  51. Caulfield T, Rachul C: Science spin: iPSC research in the news. Clin Pharmacol Ther. 2011, 89: 644-646. 10.1038/clpt.2010.309. · DOI

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Metadata

Authors
King, N. M., & Perrin, J.
Affiliations
  • Atrium Health Wake Forest Baptist (US)
  • Wake Forest University (US)
Corresponding author
King, Nancy MP
Venue
Stem Cell Research & Therapy
Published
2014-07-07
Volume
5
Issue
4
Pages
85-85
ISSN
1757-6512 (ISSN-L)
OpenAlex
W2124965012
Cited by
267
References
0
Citations by year
2026: 19 · 2025: 40 · 2024: 28 · 2023: 27 · 2022: 27 · 2021: 28 · 2020: 25 · 2019: 19 · 2018: 22 · 2017: 12 · 2016: 6 · 2015: 12 · 2014: 1
FWCI
1.21
Type
journal article
Language
en
Open access
Locations
  • Stem Cell Research & Therapy (publishedVersion, cc-by)
  • Europe PMC (PubMed Central) (publishedVersion, cc-by)
  • PubMed Central (publishedVersion, cc-by)
  • PubMed (publishedVersion)
Topics
  • Health Sciences › Nursing › Issues, ethics and legal aspects › Biomedical Ethics and Regulation
  • Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Ethics in Clinical Research
  • Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Ethics and bioethics in healthcare
Keywords
stem cell research ethics, human embryonic stem cells, moral status of embryos, induced pluripotent stem cells, multipotent stem cells, mesenchymal stem cells, biobanking, informed consent, therapeutic misconception, risk minimization, translational research, stem cell therapy, science policy, justice in research
MeSH terms
Clinical Trials as Topic, Humans, Cell Culture Techniques, Stem Cell Transplantation, Embryonic Stem Cells, Stem Cell Research, Cell- and Tissue-Based Therapy

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