Ethical issues in stem cell research and therapy

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.

Article PubMed Google Scholar

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.

Article CAS PubMed Google Scholar

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]

Google Scholar

Levine R: Ethics and Regulation of Clinical Research. 1988, New York: Yale University Press

Google Scholar

Gilbert S, Kaebnick GE, Murray TH: Special Report: Animal research ethics: evolving views and practices. Hastings Center Rep. 2012, 42: S1-S39.

Article Google Scholar

Joffe S, Miller FG: Bench to bedside: mapping the moral terrain of clinical research. Hastings Center Rep. 2008, 38: 30-42.

Article Google Scholar

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.

Article PubMed Central PubMed Google Scholar

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.

Article PubMed Google Scholar

Greely H: Assessing ESCROs: yesterday and tomorrow. Am J Bioeth. 2013, 13: 44-52.

Article PubMed Google Scholar

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.

Article Google Scholar

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.

Article CAS PubMed Google Scholar

International Society for Stem Cell Research: Guidelines for the clinical translation of stem cells. [http://www.isscr.org/docs/guidelines/isscrglclinicaltrans.pdf]

Caulfield T: Stem cell research and economic promises. J Law Med Ethics. 2010, 38: 303-313. 10.1111/j.1748-720X.2010.00490.x.

Article PubMed Google Scholar

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.

Article Google Scholar

Emanuel EJ, Wendler D, Grady C: What makes clinical research ethical?. JAMA. 2000, 283: 2701-2711. 10.1001/jama.283.20.2701.

Article CAS PubMed Google Scholar

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.

Article CAS PubMed Google Scholar

London AJ, Kimmelman J, Emborg ME: Beyond access vs. protection in trials of innovative therapies. Science. 2010, 328: 829-830. 10.1126/science.1189369.

Article PubMed Central CAS PubMed Google Scholar

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.

Article CAS PubMed Google Scholar

Dresser R: First-in-human trial participants: not a vulnerable population, but vulnerable nonetheless. J Law Med Ethics. 2009, 37: 38-50.

Article PubMed Central PubMed Google Scholar

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.

Article PubMed Central PubMed Google Scholar

Dresser R: Alive and well: the research imperative. J Law Med Ethics. 2012, 40: 915-921.

Article PubMed Google Scholar

Dresser R: The ubiquity and utility of the therapeutic misconception. Soc Philos Policy. 2002, 19: 271-294. 10.1017/S0265052502192119.

Article PubMed Google Scholar

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-

Article PubMed Google Scholar

Hyun I: The bioethics of stem cell research and therapy. J Clin Invest. 2010, 120: 71-75. 10.1172/JCI40435.

Article PubMed Central CAS PubMed Google Scholar

Daley GQ: The promise and perils of stem cell therapeutics. Cell Stem Cell. 2012, 10: 740-749. 10.1016/j.stem.2012.05.010.

Article PubMed Central CAS PubMed Google Scholar

Sugarman J: Human stem cell ethics: beyond the embryo. Cell Stem Cell. 2008, 2: 529-533. 10.1016/j.stem.2008.05.005.

Article CAS PubMed Google Scholar

Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research: Guidance for industry: considerations for the design and conduct of early-phase clinical trials of cellular and gene therapy products (DRAFT). 2013, [http://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/CellularandGeneTherapy/UCM359073.pdf]

Google Scholar

Sipp D: Direct-to-consumer stem cell marketing and regulatory responses. Stem Cells Translational Med. 2013, 2: 638-640. 10.5966/sctm.2013-0040.

Article Google Scholar

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.

Article CAS PubMed Google Scholar

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.

Article Google Scholar

King NM, Coughlin CN, Atala A: Pluripotent stem cells: the search for the perfect source. Minn J Law Sci Technol. 2011, 12: 715-730.

Google Scholar

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.

Article CAS PubMed Google Scholar

Cohen CB: Renewing the Stuff of Life: Stem Cells, Ethics, and Public Policy. 2007, New York: Oxford University Press

Google Scholar

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

Google Scholar

Yamanaka S: Induced pluripotent stem cells: past, present, and future. Cell Stem Cell. 2012, 10: 678-684. 10.1016/j.stem.2012.05.005.

Article CAS PubMed Google Scholar

Pera MF: Stem cells: the dark side of induced pluripotency. Nature. 2011, 471: 46-47. 10.1038/471046a.

Article CAS PubMed Google Scholar

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.

Article CAS PubMed Google Scholar

Cyranoski D: Acid bath offers easy path to stem cells. Nature. 2014, 505: 596-10.1038/505596a.

Article CAS PubMed Google Scholar

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]

Google Scholar

Kimmelman J, Baylis F, Glass KG: Stem cell trials: lessons from gene transfer research. Hastings Cent Rep. 2006, 36: 23-26.

Article PubMed Google Scholar

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.

Article PubMed Google Scholar

Wilson JM: A history lesson for stem cells. Science. 2009, 324: 727-728. 10.1126/science.1174935.

Article CAS PubMed Google Scholar

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.

Article CAS PubMed Google Scholar

Lukovic D, Stojkovic M, Moreno-Manzano V, Bhattacharya SS, Erceg S: Perspectives and future directions of human pluripotent stem cell-based therapies: lessons from Gerons clinical trial for spinal cord injury. Stem Cells Dev. 2014, 23: 1-4. 10.1089/scd.2013.0266.

Article PubMed Google Scholar

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.

Article CAS PubMed Google Scholar

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.

Article CAS Google Scholar

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.

Article Google Scholar

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.

Article Google Scholar

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.

Article PubMed Central PubMed Google Scholar

Hyun I: The bioethics of iPS cell based drug discovery. Clin Pharmacol Ther. 2011, 89: 646-647. 10.1038/clpt.2010.308.

Article CAS PubMed Google Scholar

King NM, Coughlin CN, Furth M: Ethical issues in regenerative medicine. Wake Forest Intellectual Property Law J. 2009, 9: 216-238.

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Ethical issues in stem cell research and therapy