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Volumn 24, Issue 12, 2016, Pages 2039-2042

One size fits all?: Ethical considerations for examining efficacy in first-in-human pluripotent stem cell studies

Author keywords

[No Author keywords available]

Indexed keywords

DRUG APPROVAL; DRUG DEVELOPMENT; DRUG INDUSTRY; EMBRYONIC STEM CELL; EVIDENCE BASED MEDICINE; FOOD AND DRUG ADMINISTRATION; GRAFT VERSUS HOST REACTION; HEMATOPOIETIC STEM CELL TRANSPLANTATION; HUMAN; IMMUNE RESPONSE; INFORMED CONSENT; LAW; MEDICAL ETHICS; MEDICAL RESEARCH; NOTE; ONCOLOGY; PHASE 1 CLINICAL TRIAL (TOPIC); PHASE 2 CLINICAL TRIAL (TOPIC); PHASE 3 CLINICAL TRIAL (TOPIC); PLURIPOTENT STEM CELL; RISK BENEFIT ANALYSIS; SAFETY; SPINAL CORD INJURY; STATISTICAL ANALYSIS; STEM CELL TRANSPLANTATION; T LYMPHOCYTE; THERAPY EFFECT; TREATMENT RESPONSE; UNITED STATES; BIOTECHNOLOGY; CLINICAL RESEARCH; CLINICAL STUDY; DRUG EFFICACY; DRUG RESEARCH; DRUG SAFETY; HISTOCOMPATIBILITY; MEDICAL SOCIETY; NONHUMAN; PHARMACEUTICS; RISK REDUCTION; INDUCED PLURIPOTENT STEM CELL;

EID: 85006253469     PISSN: 15250016     EISSN: 15250024     Source Type: Journal    
DOI: 10.1038/mt.2016.202     Document Type: Note
Times cited : (4)

References (34)
  • 2
    • 85006249678 scopus 로고
    • US Department of Health Education, and Welfare. Interim Reports, vol. II, section A. Washington DC.
    • US Department of Health Education, and Welfare (1977). Review Panel on New Drug Regulation. Interim Reports, vol. II, section A. Washington DC.
    • (1977) Review Panel on New Drug Regulation
  • 3
    • 84879638317 scopus 로고    scopus 로고
    • Model-based rational design of an oncolytic virus with improved therapeutic potential
    • Le Boeuf F, Batenchuk C, Vähä-Koskela M, Breton S, Roy D, Lemay C, et al. (2013). Model-based rational design of an oncolytic virus with improved therapeutic potential. Nat Commun 4: 1974.
    • (2013) Nat Commun , vol.4 , pp. 1974
    • Le Boeuf, F.1    Batenchuk, C.2    Vähä-Koskela, M.3    Breton, S.4    Roy, D.5    Lemay, C.6
  • 4
    • 0027949027 scopus 로고
    • Simulation as a design tool for phase I/II clinical trials: An example from bone marrow transplantation
    • Gooley TA, Martin PJ, Fisher LD, and Pettinger M (1994). Simulation as a design tool for phase I/II clinical trials: an example from bone marrow transplantation. Control Clin Trials 15: 450-462.
    • (1994) Control Clin Trials , vol.15 , pp. 450-462
    • Gooley, T.A.1    Martin, P.J.2    Fisher, L.D.3    Pettinger, M.4
  • 5
    • 84952684276 scopus 로고    scopus 로고
    • Studying the lay of the land: Views, and experiences of professionals in the translational pluripotent stem cell field
    • Habets MGJL, van Delden JJM, and Bredenoord AL (2016). Studying the lay of the land: views, and experiences of professionals in the translational pluripotent stem cell field. Regen. Med 11: 63-71.
    • (2016) Regen. Med , vol.11 , pp. 63-71
    • Habets, M.G.J.L.1    Van Delden, J.J.M.2    Bredenoord, A.L.3
  • 6
    • 84860320282 scopus 로고    scopus 로고
    • Intracranial stem cell-based transplantation: Reconsidering the ethics of phase 1 clinical trials in light of irreversible interventions in the brain
    • Hess P (2012). Intracranial stem cell-based transplantation: reconsidering the ethics of phase 1 clinical trials in light of irreversible interventions in the brain. AJOB Neurosci 3: 3-13.
    • (2012) AJOB Neurosci , vol.3 , pp. 3-13
    • Hess, P.1
  • 7
    • 61449282532 scopus 로고    scopus 로고
    • Benefit in phase 1 oncology trials: Therapeutic misconception or reasonable treatment option?
    • Miller FG, and Joffe S (2008). Benefit in phase 1 oncology trials: therapeutic misconception or reasonable treatment option?. Clin Trials 5: 617-623.
    • (2008) Clin Trials , vol.5 , pp. 617-623
    • Miller, F.G.1    Joffe, S.2
  • 8
    • 33745587764 scopus 로고    scopus 로고
    • Phase i research, and the meaning of direct benefit
    • Ross L (2006). Phase I research, and the meaning of direct benefit. J Pediatr 149: S20-S24.
    • (2006) J Pediatr , vol.149 , pp. S20-S24
    • Ross, L.1
  • 9
    • 84902579985 scopus 로고    scopus 로고
    • Controlling brain cells with light: Ethical considerations for optogenetic clinical trials
    • Gilbert F, Harris AR, and Kapsa RMI (2014). Controlling brain cells with light: ethical considerations for optogenetic clinical trials. AJOB Neurosci 5: 3-11.
    • (2014) AJOB Neurosci , vol.5 , pp. 3-11
    • Gilbert, F.1    Harris, A.R.2    Kapsa, R.M.I.3
  • 10
    • 84903730726 scopus 로고    scopus 로고
    • The risk-escalation model: A principled design strategy for early-phase trials
    • Hey SP, and Kimmelman J (2014). The risk-escalation model: a principled design strategy for early-phase trials. Kennedy Inst Ethics J 24: 121-139.
    • (2014) Kennedy Inst Ethics J , vol.24 , pp. 121-139
    • Hey, S.P.1    Kimmelman, J.2
  • 11
    • 84926211549 scopus 로고    scopus 로고
    • Conditional approval: Japan lowers the bar for regenerative medicine products
    • Sipp D (2015). Conditional approval: Japan lowers the bar for regenerative medicine products. Cell Stem Cell 16: 353-356.
    • (2015) Cell Stem Cell , vol.16 , pp. 353-356
    • Sipp, D.1
  • 12
    • 0034573353 scopus 로고    scopus 로고
    • Defining, and describing benefit appropriately in clinical trials
    • King NM (2000). Defining, and describing benefit appropriately in clinical trials. J Law Med Ethics 28: 332-343.
    • (2000) J Law Med Ethics , vol.28 , pp. 332-343
    • King, N.M.1
  • 17
    • 79955676993 scopus 로고    scopus 로고
    • The tragedy of translation: The case of 'first use' in human embryonic stem cell research
    • Solbakk JH, and Zoloth L (2011). The tragedy of translation: the case of 'first use' in human embryonic stem cell research. Cell Stem Cell 8: 479-481.
    • (2011) Cell Stem Cell , vol.8 , pp. 479-481
    • Solbakk, J.H.1    Zoloth, L.2
  • 18
    • 79955681182 scopus 로고    scopus 로고
    • Response to Frederic Bretzner, et al., 'Target populations for first-in-human embryonic stem cell research in spinal cord injury
    • Wirth E, Lebkowski JS, and Lebacqz K (2011). Response to Frederic Bretzner, et al., 'Target populations for first-in-human embryonic stem cell research in spinal cord injury.' Cell Stem Cell 8: 476-478.
    • (2011) Cell Stem Cell , vol.8 , pp. 476-478
    • Wirth, E.1    Lebkowski, J.S.2    Lebacqz, K.3
  • 19
    • 79955699569 scopus 로고    scopus 로고
    • Target populations for first-in-human embryonic stem cell research in spinal cord injury
    • Bretzner F, Gilbert F, Baylis F, and Brownstone RM (2011). Target populations for first-in-human embryonic stem cell research in spinal cord injury. Cell Stem Cell 8: 468-475.
    • (2011) Cell Stem Cell , vol.8 , pp. 468-475
    • Bretzner, F.1    Gilbert, F.2    Baylis, F.3    Brownstone, R.M.4
  • 20
    • 61349126697 scopus 로고    scopus 로고
    • First-in-human trial participants: Not a vulnerable population, but vulnerable nonetheless
    • Dresser R (2009). First-in-human trial participants: not a vulnerable population, but vulnerable nonetheless. J Law Med Ethics 37: 38-50.
    • (2009) J Law Med Ethics , vol.37 , pp. 38-50
    • Dresser, R.1
  • 21
    • 35549001383 scopus 로고    scopus 로고
    • Stable ethics: Enrolling non-Treatment-refractory volunteers in novel gene transfer trials
    • Kimmelman J (2007). Stable ethics: enrolling non-Treatment-refractory volunteers in novel gene transfer trials. Mol Ther 15: 1904-1906.
    • (2007) Mol Ther , vol.15 , pp. 1904-1906
    • Kimmelman, J.1
  • 22
    • 37349089029 scopus 로고    scopus 로고
    • First-in-man (FIM) clinical trials post-TeGenero: A review of the impact of the TeGenero trial on the design, conduct, and ethics of FIM trials
    • Nada A, and Somberg J (2007). First-in-man (FIM) clinical trials post-TeGenero: a review of the impact of the TeGenero trial on the design, conduct, and ethics of FIM trials. Am J Ther 14: 594-604.
    • (2007) Am J Ther , vol.14 , pp. 594-604
    • Nada, A.1    Somberg, J.2
  • 23
    • 84952684276 scopus 로고    scopus 로고
    • Studying the lay of the land: Views, and experiences of professionals in the translational pluripotent stem cell field
    • Habets MG, van Delden JJ, and Bredenoord AL (2016). Studying the lay of the land: views, and experiences of professionals in the translational pluripotent stem cell field. Regen Med 11: 63-71.
    • (2016) Regen Med , vol.11 , pp. 63-71
    • Habets, M.G.1    Van Delden, J.J.2    Bredenoord, A.L.3
  • 24
    • 0014806577 scopus 로고
    • A compendium of reported human bone marrow transplants
    • Bortin MM (1970). A compendium of reported human bone marrow transplants. Transplantation 9: 571-587.
    • (1970) Transplantation , vol.9 , pp. 571-587
    • Bortin, M.M.1
  • 25
    • 84904055208 scopus 로고    scopus 로고
    • Continuous reduced nonrelapse mortality after allogeneic hematopoietic stem cell transplantation: A single-institution's three decade experience
    • Malard F, Chevallier P, Guillaume T, Delaunay J, Rialland F, Harousseau J-L, et al. (2014). Continuous reduced nonrelapse mortality after allogeneic hematopoietic stem cell transplantation: a single-institution's three decade experience. Biol Blood Marrow Transplant 20: 1217-1223.
    • (2014) Biol Blood Marrow Transplant , vol.20 , pp. 1217-1223
    • Malard, F.1    Chevallier, P.2    Guillaume, T.3    Delaunay, J.4    Rialland, F.5    Harousseau, J.-L.6
  • 27
    • 84861919329 scopus 로고    scopus 로고
    • Lumbar intraspinal injection of neural stem cells in patients with amyotrophic lateral sclerosis: Results of a phase i trial in 12 patients
    • Glass JD, Boulis NM, Johe K, Rutkove SB, Federici T, Polak M, et al. (2012). Lumbar intraspinal injection of neural stem cells in patients with amyotrophic lateral sclerosis: results of a phase I trial in 12 patients. Stem Cells 30: 1144-1151.
    • (2012) Stem Cells , vol.30 , pp. 1144-1151
    • Glass, J.D.1    Boulis, N.M.2    Johe, K.3    Rutkove, S.B.4    Federici, T.5    Polak, M.6
  • 28
    • 84860327256 scopus 로고    scopus 로고
    • The complex ethics of first in human stem cell clinical trials
    • Yarborough M, Tempkin T, Nolta J, and Joyce N (2012). The complex ethics of first in human stem cell clinical trials. AJOB Neurosci. 3: 14-16.
    • (2012) AJOB Neurosci. , vol.3 , pp. 14-16
    • Yarborough, M.1    Tempkin, T.2    Nolta, J.3    Joyce, N.4
  • 29
    • 39649084919 scopus 로고    scopus 로고
    • The FDA Critical Path Initiative, and its influence on new drug development
    • Woodcock J, and Woosley R (2008). The FDA Critical Path Initiative, and its influence on new drug development. Annu Rev Med 59: 1-12.
    • (2008) Annu Rev Med , vol.59 , pp. 1-12
    • Woodcock, J.1    Woosley, R.2
  • 30
    • 84953254457 scopus 로고    scopus 로고
    • Assessing risk/benefit for trials using preclinical evidence: A proposal
    • Kimmelman J, and Henderson V (2016). Assessing risk/benefit for trials using preclinical evidence: a proposal. J Med Ethics 42: 50-53.
    • (2016) J Med Ethics , vol.42 , pp. 50-53
    • Kimmelman, J.1    Henderson, V.2
  • 32
    • 4344591881 scopus 로고    scopus 로고
    • Uncertain benefit: Investigators' views, and communications in early phase gene transfer trials
    • Henderson GE, Davis AM, King NMP, Easter MM, Zimmer CR, Rothschild BB, et al. (2004). Uncertain benefit: investigators' views, and communications in early phase gene transfer trials. Mol Ther 10: 225-231.
    • (2004) Mol Ther , vol.10 , pp. 225-231
    • Henderson, G.E.1    Davis, A.M.2    King, N.M.P.3    Easter, M.M.4    Zimmer, C.R.5    Rothschild, B.B.6
  • 33
    • 84939260930 scopus 로고    scopus 로고
    • Seamless phase I/II adaptive design for oncology trials of molecularly targeted agents
    • Wages NA, and Tait C (2014). Seamless phase I/II adaptive design for oncology trials of molecularly targeted agents. J Biopharm Stat 25: 903-920.
    • (2014) J Biopharm Stat , vol.25 , pp. 903-920
    • Wages, N.A.1    Tait, C.2
  • 34
    • 33845993628 scopus 로고    scopus 로고
    • A clinical development paradigm for cancer vaccines, and related biologics
    • Hoos A, Parmiani G, Hege K, Sznol M, Loibner H, Eggermont A, et al. (2007). A clinical development paradigm for cancer vaccines, and related biologics. J Immunother 30: 1-15.
    • (2007) J Immunother , vol.30 , pp. 1-15
    • Hoos, A.1    Parmiani, G.2    Hege, K.3    Sznol, M.4    Loibner, H.5    Eggermont, A.6


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