메뉴 건너뛰기




Volumn 16, Issue 4, 2009, Pages 175-198

Risk of tumorigenesis in first-in-human trials of embryonic stem cell neural derivatives: Ethics in the face of long-term uncertainty

Author keywords

Clinical trials; Ethics; Human embryonic stem cells; Neurodegenerative diseases; Spinal cord injury

Indexed keywords

ARTICLE; CLINICAL TRIAL; DEGENERATIVE DISEASE; EMBRYONIC STEM CELL; ETHICS; HUMAN; INFORMED CONSENT; MONITORING; NEOPLASM; RISK ASSESSMENT; SPINAL CORD INJURY; TRANSPLANTATION; UNCERTAINTY;

EID: 70449632589     PISSN: 08989621     EISSN: 15455815     Source Type: Journal    
DOI: 10.1080/08989620903065145     Document Type: Article
Times cited : (27)

References (55)
  • 1
    • 70449645691 scopus 로고    scopus 로고
    • Advanced Cell Technology, Available at:, Accessed May 20
    • Advanced Cell Technology. (2009). Retinal pigmented epithelial cell program. Available at: http://www.advancedcell.com/rpe-program. Accessed May 20, 2009.
    • (2009) Retinal Pigmented Epithelial Cell Program , vol.20 , pp. 2009
  • 2
    • 62149089434 scopus 로고    scopus 로고
    • Geron gets green light for human trial of ES-cell-derived product
    • Alper, J. (2009). Geron gets green light for human trial of ES-cell-derived product. Nature Biotechnology 27: 213-214.
    • (2009) Nature Biotechnology , vol.27 , pp. 213-214
    • Alper, J.1
  • 5
    • 70449639181 scopus 로고    scopus 로고
    • Prepping stem cells for the clinic
    • April 10 2008. Available at:, Accessed March 30, 2009
    • Baker, M. (2008). Prepping stem cells for the clinic. Nature Reports Stem Cells, April 10 2008. Available at: http://www.nature.com/stemcells/2008/0804/080410/full/stemcells.2008.59.html. Accessed March 30, 2009.
    • (2008) Nature Reports Stem Cells
    • Baker, M.1
  • 6
    • 33845891659 scopus 로고
    • Protection of human subjects: Ethical principles and guidelines for the protection of human subjects of research
    • Belmont Report
    • Belmont Report. (1979). Protection of human subjects: Ethical principles and guidelines for the protection of human subjects of research. Fed Regist, 44: 23192-23197.
    • (1979) Fed Regist , vol.44 , pp. 23192-23197
  • 7
    • 46449113364 scopus 로고    scopus 로고
    • The tumorigenicity of human embryonic stem cells
    • Blum, B., and Benvenisty, N. (2008). The tumorigenicity of human embryonic stem cells. Advances in Cancer Research, 100: 133-158.
    • (2008) Advances in Cancer Research , vol.100 , pp. 133-158
    • Blum, B.1    Benvenisty, N.2
  • 10
    • 34249694635 scopus 로고    scopus 로고
    • Transplantation of human embryonic stem cell-derived oligodendrocyte progenitors into rat spinal cord injuries does not cause harm
    • Cloutier, F., Siegenthaler, M. M., Nistor, G., and Keirstead, H. S. (2006). Transplantation of human embryonic stem cell-derived oligodendrocyte progenitors into rat spinal cord injuries does not cause harm. Regenerative Medicine, 1: 469-479.
    • (2006) Regenerative Medicine , vol.1 , pp. 469-479
    • Cloutier, F.1    Siegenthaler, M.M.2    Nistor, G.3    Keirstead, H.S.4
  • 11
    • 0003433351 scopus 로고    scopus 로고
    • Council for International Organizations of Medical Sciences (CIOMS), Available at:, Accessed March 30, 2009
    • Council for International Organizations of Medical Sciences (CIOMS). (2002). International ethical guidelines for biomedical research involving human subjects. Available at: www.cioms.ch/frame_guidelines_nov_2002.htm. Accessed March 30, 2009.
    • (2002) International Ethical Guidelines for Biomedical Research Involving Human Subjects
  • 12
    • 59149092225 scopus 로고    scopus 로고
    • Celebration and concern over U.S. trial of embryonic stem cells
    • Couzin, J. (2009). Celebration and concern over U.S. trial of embryonic stem cells. Science, 323:568.
    • (2009) Science , vol.323 , pp. 568
    • Couzin, J.1
  • 14
    • 41049107096 scopus 로고    scopus 로고
    • Human embryonic stem cells: Preclinical perspectives
    • Deb, K. D., and Sarda, K. (2008). Human embryonic stem cells: preclinical perspectives. Journal of Translational Medicine, 29:7.
    • (2008) Journal of Translational Medicine , vol.29 , pp. 7
    • Deb, K.D.1    Sarda, K.2
  • 15
    • 0034737962 scopus 로고    scopus 로고
    • What makes clinical research ethical?
    • Emanuel, E. J., Wendler, D., and Grady, C. (2000). What makes clinical research ethical? JAMA, 283: 2701-2011.
    • (2000) JAMA , vol.283 , pp. 2701-2011
    • Emanuel, E.J.1    Wendler, D.2    Grady, C.3
  • 16
    • 33846652908 scopus 로고    scopus 로고
    • Scrutinizing a stem cell trial
    • March 29. Available at:, Accessed March 30, 2009
    • Edwards, S. (2006). Scrutinizing a stem cell trial. Wired March 29. Available at: http://www.wired.com/medtech/health/news/2006/03/70521. Accessed March 30, 2009.
    • (2006) Wired
    • Edwards, S.1
  • 19
    • 70449653652 scopus 로고    scopus 로고
    • Briefing Documents: Cellular Therapies Derived from Human Embryonic Stem Cells
    • Food and Drug Administration (FDA), Available at:, Accessed March 30, 2009
    • Food and Drug Administration (FDA). (2008a). Briefing Documents: Cellular Therapies Derived from Human Embryonic Stem Cells. Considerations for Pre-Clinical Safety Testing and Patient Monitoring. Available at: www.fda.gov/ohrms/dockets/ac/08/briefing/2008-0471B1_1.pdf. Accessed March 30, 2009.
    • (2008) Considerations for Pre-Clinical Safety Testing and Patient Monitoring
  • 20
    • 70449653652 scopus 로고    scopus 로고
    • Transcripts: 45th Meeting of the Center for Biologics Evaluation and Research, Food and Drug Administration. Cellular Therapies Derived from Human Embryonic Stem Cells
    • Food and Drug Administration (FDA), Available at:, (-02, -03, -04, -05). Accessed March 30, 2009
    • Food and Drug Administration (FDA). (2008b). Transcripts: 45th Meeting of the Center for Biologics Evaluation and Research, Food and Drug Administration. Cellular Therapies Derived from Human Embryonic Stem Cells. Considerations for Pre-Clinical Safety Testing and Patient Monitoring. Available at: http://www.fda.gov/OHRMS/DOCKETS/ac/08/transcripts/2008-0471t1-01.htm (-02, -03, -04, -05). Accessed March 30, 2009.
    • (2008) Considerations for Pre-Clinical Safety Testing and Patient Monitoring
  • 23
    • 42149116544 scopus 로고    scopus 로고
    • Human embryonic stem cells: A potential source of transplantable neural progenitor cells
    • Guillaume, D. J., and Zhang, S. C. (2008). Human embryonic stem cells: a potential source of transplantable neural progenitor cells. Neurosurgical Focus, 24: 1-7.
    • (2008) Neurosurgical Focus , vol.24 , pp. 1-7
    • Guillaume, D.J.1    Zhang, S.C.2
  • 24
    • 33749504926 scopus 로고    scopus 로고
    • Concise review: Scientific and ethical roadblocks to human embryonic stem cell therapy
    • Gruen, L., and Grabel, L. (2006). Concise review: Scientific and ethical roadblocks to human embryonic stem cell therapy. Stem Cells, 24: 2162-2169.
    • (2006) Stem Cells , vol.24 , pp. 2162-2169
    • Gruen, L.1    Grabel, L.2
  • 25
    • 33845618031 scopus 로고    scopus 로고
    • Cell therapy and the safety of embryonic stem cell-derived grafts
    • Hentze, H., Graichen, R., and Colman, A. (2007). Cell therapy and the safety of embryonic stem cell-derived grafts. Trends in Biotechnology, 25: 24-32.
    • (2007) Trends in Biotechnology , vol.25 , pp. 24-32
    • Hentze, H.1    Graichen, R.2    Colman, A.3
  • 26
    • 70449521274 scopus 로고    scopus 로고
    • International Society for Stem Cell Research (ISSCR), Available at:, Accessed March 30
    • International Society for Stem Cell Research (ISSCR). (2008). Guidelines for the clinical translation of stem cells. Available at: http://www.isscr.org/ clinical_trans/pdfs/ISSCRGLClinicalTrans.pdf. Accessed March 30, 2009.
    • (2008) Guidelines for the Clinical Translation of Stem Cells , pp. 2009
  • 27
    • 37849038986 scopus 로고    scopus 로고
    • Human embryonic stem cells: An experimental and therapeutic resource for neurological disease
    • Joannides, A. J., and Chandran, S. (2008). Human embryonic stem cells: An experimental and therapeutic resource for neurological disease. Journal of the Neurological Sciences, 265: 84-88.
    • (2008) Journal of the Neurological Sciences , vol.265 , pp. 84-88
    • Joannides, A.J.1    Chandran, S.2
  • 28
    • 18644384444 scopus 로고    scopus 로고
    • Human embryonic stem cell-derived oligodendrocyte progenitor cell transplants remyelinate and restore locomotion after spinal cord injury
    • Keirstead, H. S., Nistor, G., Bernal, G., Totoiu, M., Cloutier, F., Sharp, K., and Steward, O. (2005). Human embryonic stem cell-derived oligodendrocyte progenitor cell transplants remyelinate and restore locomotion after spinal cord injury. Journal of Neuroscience, 25: 4694-4705.
    • (2005) Journal of Neuroscience , vol.25 , pp. 4694-4705
    • Keirstead, H.S.1    Nistor, G.2    Bernal, G.3    Totoiu, M.4    Cloutier, F.5    Sharp, K.6    Steward, O.7
  • 29
    • 0034235566 scopus 로고    scopus 로고
    • Anxiety and depression after spinal cord injury: A longitudinal analysis
    • Kennedy, P., and Rogers, B. A. (2000). Anxiety and depression after spinal cord injury: A longitudinal analysis. Archives of Physical Medicine and Rehabilitation, 81: 932-937.
    • (2000) Archives of Physical Medicine and Rehabilitation , vol.81 , pp. 932-937
    • Kennedy, P.1    Rogers, B.A.2
  • 30
    • 11844303500 scopus 로고    scopus 로고
    • Recent developments in gene transfer: Risk and ethics
    • Kimmelman, J. (2005). Recent developments in gene transfer: Risk and ethics. BMJ.com 330: 79--82.
    • (2005) BMJ.com , vol.330 , pp. 79-82
    • Kimmelman, J.1
  • 31
    • 33644505523 scopus 로고    scopus 로고
    • Stem cell trials: Lessons from gene transfer research
    • Kimmelman, J., Baylis, F., and Glass, K. C. (2006). Stem cell trials: Lessons from gene transfer research. Hastings Center Report, 36: 23-26.
    • (2006) Hastings Center Report , vol.36 , pp. 23-26
    • Kimmelman, J.1    Baylis, F.2    Glass, K.C.3
  • 32
    • 39449124736 scopus 로고    scopus 로고
    • The ethics of human gene transfer
    • Kimmelman, J. (2008). The ethics of human gene transfer. Nature Reviews Genetics, 9: 239-244.
    • (2008) Nature Reviews Genetics , vol.9 , pp. 239-244
    • Kimmelman, J.1
  • 33
    • 0029019672 scopus 로고
    • Comparison between acute and delayed onset major depression after spinal cord injury
    • Kishi, Y., Robinson, R. G., and Forrester, A. W. (1995). Comparison between acute and delayed onset major depression after spinal cord injury. Journal of Nervous and Mental Disease, 183: 286-292.
    • (1995) Journal of Nervous and Mental Disease , vol.183 , pp. 286-292
    • Kishi, Y.1    Robinson, R.G.2    Forrester, A.W.3
  • 36
    • 33947210382 scopus 로고    scopus 로고
    • Benefits, risks and ethical considerations in translation of stem cell research to clinical applications in Parkinson
    • Master, Z., McLeod, M., and Mendez, I. (2007). Benefits, risks and ethical considerations in translation of stem cell research to clinical applications in Parkinson. Journal of Medical Ethics, 33: 169-173.
    • (2007) Journal of Medical Ethics , vol.33 , pp. 169-173
    • Master, Z.1    McLeod, M.2    Mendez, I.3
  • 39
    • 70449518387 scopus 로고    scopus 로고
    • National Institutes of Health (NIH), Available at:, Accessed March 30, 2009
    • National Institutes of Health (NIH). (2003). Guidance on Informed Consent for Gene Transfer Research. Available at: http://oba.od.nih.gov/oba/rac/ic/index.html. Accessed March 30, 2009.
    • (2003) Guidance on Informed Consent for Gene Transfer Research
  • 40
    • 70449641861 scopus 로고    scopus 로고
    • Assessing human stem cell safety
    • National Institutes of Health (NIH), Bethesda, MD: National Institutes of Health, U.S. Department of Health and Human Services. Available at:, Accessed March 20, 2009
    • National Institutes of Health (NIH). (2009a). Assessing human stem cell safety. In Stem Cell Information [World Wide Web site]. Bethesda, MD: National Institutes of Health, U.S. Department of Health and Human Services. Available at: http://stemcells.nih.gov/info/scireport/chapter10. Accessed March 20, 2009.
    • (2009) Stem Cell Information [World Wide Web site]
  • 41
    • 70449653281 scopus 로고    scopus 로고
    • National Institutes of Health (NIH), Available at:, Accessed March 30, 2009
    • National Institutes of Health (NIH). (2009b). Brain and spinal tumors. Hope through research. Available at: http://www.ninds.nih.gov/disorders/brainandspinaltumors/detail_brainandspinaltumors.html. Accessed March 30, 2009.
    • (2009) Brain and Spinal Tumors. Hope through Research
  • 44
    • 27144522018 scopus 로고    scopus 로고
    • Differentiation of human embryonic stem cells after transplantation in immune-deficient mice
    • Przyborski, S. A. (2005). Differentiation of human embryonic stem cells after transplantation in immune-deficient mice. Stem Cells, 9: 1242-1250.
    • (2005) Stem Cells , vol.9 , pp. 1242-1250
    • Przyborski, S.A.1
  • 45
    • 37749014948 scopus 로고    scopus 로고
    • Scalable human ES culture for therapeutic use: Propagation, differentiation, genetic modification and regulatory issues
    • Rao, M. (2008). Scalable human ES culture for therapeutic use: Propagation, differentiation, genetic modification and regulatory issues. Gene Therapy, 15: 82-88.
    • (2008) Gene Therapy , vol.15 , pp. 82-88
    • Rao, M.1
  • 46
    • 33750706917 scopus 로고    scopus 로고
    • Functional engraftment of human ES cell-derived dopaminergic neurons enriched by coculture with telomerase-immortalized midbrain astrocytes
    • Roy, N., Cleren, C., Singh, S., Yang, L., Beal, M., and Goldman, S. (2006). Functional engraftment of human ES cell-derived dopaminergic neurons enriched by coculture with telomerase-immortalized midbrain astrocytes. Nature Medicine, 12: 1259-1268.
    • (2006) Nature Medicine , vol.12 , pp. 1259-1268
    • Roy, N.1    Cleren, C.2    Singh, S.3    Yang, L.4    Beal, M.5    Goldman, S.6
  • 47
    • 42149083502 scopus 로고    scopus 로고
    • Stem cells: New frontiers of ethics, law and policy
    • Scott, C. T. (2008). Stem cells: New frontiers of ethics, law and policy. Neurosurgery Focus, 24: 1-4.
    • (2008) Neurosurgery Focus , vol.24 , pp. 1-4
    • Scott, C.T.1
  • 48
    • 59849122190 scopus 로고    scopus 로고
    • Celebrating 10 years of hESC lines: An interview with Peter Andrews
    • Stojkovic, M., and Daher, S. (2008). Celebrating 10 years of hESC lines: An interview with Peter Andrews. Stem Cells, 27: 4-6.
    • (2008) Stem Cells , vol.27 , pp. 4-6
    • Stojkovic, M.1    Daher, S.2
  • 49
    • 34547489963 scopus 로고    scopus 로고
    • Human embryonic stem cell-derived neural precursor transplants attenuate apomorphine-induced rotational behavior in rats with unilateral quinolinic acid lesions
    • Song, J., Lee, S. T., Kang, W., Park, J. E., Chu, K., Lee, S. E., Hwang, T., Chung, H., and Kim, M. (2007). Human embryonic stem cell-derived neural precursor transplants attenuate apomorphine-induced rotational behavior in rats with unilateral quinolinic acid lesions. Neuroscience Letters, 423: 58-61.
    • (2007) Neuroscience Letters , vol.423 , pp. 58-61
    • Song, J.1    Lee, S.T.2    Kang, W.3    Park, J.E.4    Chu, K.5    Lee, S.E.6    Hwang, T.7    Chung, H.8    Kim, M.9
  • 52
    • 20644447816 scopus 로고    scopus 로고
    • Ready or not? Human ES cells head toward the clinic
    • Vogel, G. (2005). Ready or not? Human ES cells head toward the clinic. Science, 308: 1534-1538.
    • (2005) Science , vol.308 , pp. 1534-1538
    • Vogel, G.1
  • 53
    • 38349004470 scopus 로고    scopus 로고
    • Human embryonic stem cell-derived dopaminergic neurons reverse functional deficit in parkinsonian rats
    • Yang, D., Zhang, Z. J., Oldenburg, M., Ayala, M., and Zhang, S. C. (2008). Human embryonic stem cell-derived dopaminergic neurons reverse functional deficit in parkinsonian rats. Stem Cells, 26: 55-63.
    • (2008) Stem Cells , vol.26 , pp. 55-63
    • Yang, D.1    Zhang, Z.J.2    Oldenburg, M.3    Ayala, M.4    Zhang, S.C.5
  • 54
    • 40449088049 scopus 로고    scopus 로고
    • Moving toward transparency of clinical trials
    • Zarin, D. A., and Tse, T. (2008). Moving toward transparency of clinical trials. Science, 319: 1340-1342.
    • (2008) Science , vol.319 , pp. 1340-1342
    • Zarin, D.A.1    Tse, T.2
  • 55
    • 0035200623 scopus 로고    scopus 로고
    • In vitro differentiation of transplantable neural precursors from human embryonic stem cells
    • Zhang, S. C., Wernig, M., Duncan, I. D., Brüstle, O., and Thomson, J. A. (2001). In vitro differentiation of transplantable neural precursors from human embryonic stem cells. Nature Biotechnology, 19: 1129-1133.
    • (2001) Nature Biotechnology , vol.19 , pp. 1129-1133
    • Zhang, S.C.1    Wernig, M.2    Duncan, I.D.3    Brüstle, O.4    Thomson, J.A.5


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.