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Volumn 20, Issue 19-20, 2014, Pages 2567-2574

Stem cell trials for cardiovascular medicine: Ethical rationale

Author keywords

[No Author keywords available]

Indexed keywords

BIOMEDICAL EQUIPMENT; CELLS; CYTOLOGY; PHILOSOPHICAL ASPECTS; RISK ASSESSMENT;

EID: 84911886706     PISSN: 19373341     EISSN: 1937335X     Source Type: Journal    
DOI: 10.1089/ten.tea.2013.0332     Document Type: Article
Times cited : (20)

References (70)
  • 1
    • 41949139826 scopus 로고    scopus 로고
    • A proposed definition of regenerative medicine
    • Daar, A.S., and Greenwood, H.L. A proposed definition of regenerative medicine. J Tissue Eng Regen Med 1, 179, 2007.
    • (2007) J Tissue Eng Regen Med , vol.1 , pp. 179
    • Daar, A.S.1    Greenwood, H.L.2
  • 3
    • 33845338724 scopus 로고    scopus 로고
    • Projections of global mortality and burden of disease from 2002 to 2030
    • Mathers, C.D., and Loncar, D. Projections of global mortality and burden of disease from 2002 to 2030. PLoS Med 3, e442, 2006.
    • (2006) PLoS Med , vol.3 , pp. e442
    • Mathers, C.D.1    Loncar, D.2
  • 6
    • 70349868339 scopus 로고    scopus 로고
    • Medicine on the fringe: Stem cell-based interventions in advance of evidence
    • Regenberg, A.C., Hutchinson, L.A., Schanker, B., and Mathews, D.J. Medicine on the fringe: stem cell-based interventions in advance of evidence. Stem Cells 27, 2312, 2009.
    • (2009) Stem Cells , vol.27 , pp. 2312
    • Regenberg, A.C.1    Hutchinson, L.A.2    Schanker, B.3    Mathews, D.J.4
  • 7
    • 56549103448 scopus 로고    scopus 로고
    • Stem cell clinics online: The direct-to-consumer portrayal of stem cell medicine
    • Lau, D., Ogbogu, U., Taylor, B., Stafinski, T., Menon, D., and Caulfield, T. Stem cell clinics online: the direct-to-consumer portrayal of stem cell medicine. Cell Stem Cell 3, 591, 2008.
    • (2008) Cell Stem Cell , vol.3 , pp. 591
    • Lau, D.1    Ogbogu, U.2    Taylor, B.3    Stafinski, T.4    Menon, D.5    Caulfield, T.6
  • 8
    • 84871583959 scopus 로고    scopus 로고
    • Regenerative medicine interventions for orthopedic disorders: Ethical issues in the translation into patients
    • Niemansburg, S.L., van Delden, J.J., Dhert, W.J., and Bredenoord, A.L. Regenerative medicine interventions for orthopedic disorders: ethical issues in the translation into patients. Regen Med 8, 65, 2013.
    • (2013) Regen Med , vol.8 , pp. 65
    • Niemansburg, S.L.1    Van Delden, J.J.2    Dhert, W.J.3    Bredenoord, A.L.4
  • 9
    • 65649136956 scopus 로고    scopus 로고
    • Ethical issues in stem cell research
    • Lo, B., and Parham, L. Ethical issues in stem cell research. Endocr Rev 30, 204, 2009.
    • (2009) Endocr Rev , vol.30 , pp. 204
    • Lo, B.1    Parham, L.2
  • 10
    • 77954914729 scopus 로고    scopus 로고
    • Translating stem cell research: Challenges at the research frontier
    • Magnus, D. Translating stem cell research: challenges at the research frontier. J Law Med Ethics 38, 267, 2010.
    • (2010) J Law Med Ethics , vol.38 , pp. 267
    • Magnus, D.1
  • 11
    • 56849085824 scopus 로고    scopus 로고
    • Ethical reflections on clinical trials with human tissue engineered products
    • Trommelmans, L., Selling, J., and Dierickx, K. Ethical reflections on clinical trials with human tissue engineered products. J Med Ethics 34, e1, 2008.
    • (2008) J Med Ethics , vol.34 , pp. e1
    • Trommelmans, L.1    Selling, J.2    Dierickx, K.3
  • 14
    • 84901380655 scopus 로고    scopus 로고
    • Ethics and uncertainty: Considerations for the design and review of translational trials involving stem cells
    • Hug, K., and Hermeren, G., eds New York, NY: Humana Press
    • Anderson, J.A., and Kimmelman, J. Ethics and uncertainty: considerations for the design and review of translational trials involving stem cells. In: Hug, K., and Hermeren, G., eds. Translational Stem Cell Research. New York, NY: Humana Press, 2011, pp. 403-418.
    • (2011) Translational Stem Cell Research , pp. 403-418
    • Anderson, J.A.1    Kimmelman, J.2
  • 15
    • 77952970814 scopus 로고    scopus 로고
    • Is tissue engineering a new paradigm in medicine? Consequences for the ethical evaluation of tissue engineering research
    • Trommelmans, L., Selling, J., and Dierickx, K. Is tissue engineering a new paradigm in medicine? Consequences for the ethical evaluation of tissue engineering research. Med Health Care Philos 12, 459, 2009.
    • (2009) Med Health Care Philos , vol.12 , pp. 459
    • Trommelmans, L.1    Selling, J.2    Dierickx, K.3
  • 16
    • 77952120584 scopus 로고    scopus 로고
    • Rationale and design of the JUVENTAS trial for repeated intra-arterial infusion of autologous bone marrow-derived mononuclear cells in patients with critical limb ischemia
    • Sprengers, R.W., Moll, F.L., Teraa, M., and Verhaar, M.C. Rationale and design of the JUVENTAS trial for repeated intra-arterial infusion of autologous bone marrow-derived mononuclear cells in patients with critical limb ischemia. J Vasc Surg 51, 1564, 2010.
    • (2010) J Vasc Surg , vol.51 , pp. 1564
    • Sprengers, R.W.1    Moll, F.L.2    Teraa, M.3    Verhaar, M.C.4
  • 17
    • 0035857966 scopus 로고    scopus 로고
    • The CONSORT statement: Revised recommendations for improving the quality of reports of parallel-group randomised trials
    • Moher, D., Schulz, K.F., and Altman, D.G. The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomised trials. Lancet 357, 1191, 2001.
    • (2001) Lancet , vol.357 , pp. 1191
    • Moher, D.1    Schulz, K.F.2    Altman, D.G.3
  • 19
    • 42249088748 scopus 로고    scopus 로고
    • Progenitor cell therapy in patients with critical limb ischemia without surgical options
    • Sprengers, R.W., Lips, D.J., Moll, F.L., and Verhaar, M.C. Progenitor cell therapy in patients with critical limb ischemia without surgical options. Ann Surg 247, 411, 2008.
    • (2008) Ann Surg , vol.247 , pp. 411
    • Sprengers, R.W.1    Lips, D.J.2    Moll, F.L.3    Verhaar, M.C.4
  • 20
    • 84879195592 scopus 로고    scopus 로고
    • Bone marrow stem cell treatment for ischemic heart disease in patients with no option of revascularization: A systematic review and meta-analysis
    • Fisher, S.A., Doree, C., Brunskill, S.J., Mathur, A., and Martin-Rendon, E. Bone marrow stem cell treatment for ischemic heart disease in patients with no option of revascularization: a systematic review and meta-analysis. PLoS One 8, e64669, 2013.
    • (2013) PLoS One , vol.8
    • Fisher, S.A.1    Doree, C.2    Brunskill, S.J.3    Mathur, A.4    Martin-Rendon, E.5
  • 23
    • 1842507654 scopus 로고    scopus 로고
    • Profoundly reduced neovascularization capacity of bone marrow mononuclear cells derived from patients with chronic ischemic heart disease
    • Heeschen, C., Lehmann, R., Honold, J., Assmus, B., Aicher, A., Walter, D.H., Martin, H., Zeiher, A.M., and Dimmeler, S. Profoundly reduced neovascularization capacity of bone marrow mononuclear cells derived from patients with chronic ischemic heart disease. Circulation 109, 1615, 2004.
    • (2004) Circulation , vol.109 , pp. 1615
    • Heeschen, C.1    Lehmann, R.2    Honold, J.3    Assmus, B.4    Aicher, A.5    Walter, D.H.6    Martin, H.7    Zeiher, A.M.8    Dimmeler, S.9
  • 24
    • 0034737962 scopus 로고    scopus 로고
    • What makes clinical research ethical?
    • Emanuel, E.J., Wendler, D., and Grady, C. What makes clinical research ethical? JAMA 283, 2701, 2000.
    • (2000) JAMA , vol.283 , pp. 2701
    • Emanuel, E.J.1    Wendler, D.2    Grady, C.3
  • 25
    • 0034573353 scopus 로고    scopus 로고
    • Defining and describing benefit appropriately in clinical trials
    • King, N.M. Defining and describing benefit appropriately in clinical trials. J Law Med Ethics 28, 332, 2000.
    • (2000) J Law Med Ethics , vol.28 , pp. 332
    • King, N.M.1
  • 26
    • 79953704023 scopus 로고    scopus 로고
    • Predicting harms and benefits in translational trials: Ethics, evidence, and uncertainty
    • Kimmelman, J., and London, A.J. Predicting harms and benefits in translational trials: ethics, evidence, and uncertainty. PLoS Med 8, e1001010, 2011.
    • (2011) PLoS Med , vol.8
    • Kimmelman, J.1    London, A.J.2
  • 27
    • 0033598325 scopus 로고    scopus 로고
    • The ethical problems with sham surgery in clinical research
    • Macklin, R. The ethical problems with sham surgery in clinical research. N Engl J Med 341, 992, 1999.
    • (1999) N Engl J Med , vol.341 , pp. 992
    • Macklin, R.1
  • 28
    • 84862977207 scopus 로고    scopus 로고
    • Informed consent and placebo effects: A content analysis of information leaflets to identify what clinical trial participants are told about placebos
    • Bishop, F.L., Adams, A.E., Kaptchuk, T.J., and Lewith, G.T. Informed consent and placebo effects: a content analysis of information leaflets to identify what clinical trial participants are told about placebos. PLoS One 7, e39661, 2012.
    • (2012) PLoS One , vol.7
    • Bishop, F.L.1    Adams, A.E.2    Kaptchuk, T.J.3    Lewith, G.T.4
  • 31
    • 80051605726 scopus 로고    scopus 로고
    • A framework for risk-benefit evaluations in biomedical research
    • Rid, A., and Wendler, D. A framework for risk-benefit evaluations in biomedical research. Kennedy Inst Ethics J 21, 141, 2011.
    • (2011) Kennedy Inst Ethics J , vol.21 , pp. 141
    • Rid, A.1    Wendler, D.2
  • 32
    • 84868119129 scopus 로고    scopus 로고
    • Re: Angiographic demonstration of neoangiogenesis after intraarterial infusion of autologous bone marrow mononuclear cells in diabetic patients with critical limb ischemia
    • Teraa, M., Sprengers, R.W., Leiner, T., and Verhaar, M.C. Re: angiographic demonstration of neoangiogenesis after intraarterial infusion of autologous bone marrow mononuclear cells in diabetic patients with critical limb ischemia. Cell Transplant 21, 1803, 2012.
    • (2012) Cell Transplant , vol.21 , pp. 1803
    • Teraa, M.1    Sprengers, R.W.2    Leiner, T.3    Verhaar, M.C.4
  • 35
    • 84858597644 scopus 로고    scopus 로고
    • Health related quality of life in patients with critical limb ischemia
    • Lawall, H., Zemmrich, C., Bramlage, P., and Amann, B. Health related quality of life in patients with critical limb ischemia. Vasa 41, 78, 2012.
    • (2012) Vasa , vol.41 , pp. 78
    • Lawall, H.1    Zemmrich, C.2    Bramlage, P.3    Amann, B.4
  • 36
    • 76149124264 scopus 로고    scopus 로고
    • Challenges and recommendations for placebo controls in randomized trials in physical and rehabilitation medicine: A report of the international placebo symposium working group
    • Fregni, F., Imamura, M., Chien, H.F., Lew, H.L., Boggio, P., Kaptchuk, T.J., Riberto, M., Hsing, W.T., Battistella, L.R., and Furlan, A. Challenges and recommendations for placebo controls in randomized trials in physical and rehabilitation medicine: a report of the international placebo symposium working group. Am J Phys Med Rehabil 89, 160, 2010.
    • (2010) Am J Phys Med Rehabil , vol.89 , pp. 160
    • Fregni, F.1    Imamura, M.2    Chien, H.F.3    Lew, H.L.4    Boggio, P.5    Kaptchuk, T.J.6    Riberto, M.7    Hsing, W.T.8    Battistella, L.R.9    Furlan, A.10
  • 38
    • 1242306788 scopus 로고    scopus 로고
    • Sham surgery: An ethical analysis
    • Miller, F.G. Sham surgery: an ethical analysis. Sci Eng Ethics 10, 157, 2004.
    • (2004) Sci Eng Ethics , vol.10 , pp. 157
    • Miller, F.G.1
  • 39
    • 0037352237 scopus 로고    scopus 로고
    • Ethical framework for the use of sham procedures in clinical trials
    • Horng, S., and Miller, F.G. Ethical framework for the use of sham procedures in clinical trials. Crit Care Med 31, S126, 2003.
    • (2003) Crit Care Med , vol.31 , pp. S126
    • Horng, S.1    Miller, F.G.2
  • 40
    • 84876850294 scopus 로고    scopus 로고
    • The ethics of sham surgery in Parkinson's disease: Back to the future?
    • Swift, T., and Huxtable, R. The ethics of sham surgery in Parkinson's disease: back to the future? Bioethics 27, 175, 2013.
    • (2013) Bioethics , vol.27 , pp. 175
    • Swift, T.1    Huxtable, R.2
  • 41
    • 84866918071 scopus 로고    scopus 로고
    • Ethical issues in the design of randomized trials: To sham or not to sham
    • Dowrick, A.S., and Bhandari, M. Ethical issues in the design of randomized trials: to sham or not to sham. J Bone Joint Surg Am 94 Suppl 1, 7, 2012.
    • (2012) J Bone Joint Surg Am , vol.94 , pp. 7
    • Dowrick, A.S.1    Bhandari, M.2
  • 42
    • 38449111652 scopus 로고    scopus 로고
    • Surgery as placebo: A quantitative study of bias 1961
    • Beecher, H.K. Surgery as placebo: a quantitative study of bias. 1961. Int Anesthesiol Clin 45, 35, 2007.
    • (2007) Int Anesthesiol Clin , vol.45 , pp. 35
    • Beecher, H.K.1
  • 45
    • 33746771342 scopus 로고    scopus 로고
    • Placebo surgery research: A blinding imperative
    • Heckerling, P.S. Placebo surgery research: a blinding imperative. J Clin Epidemiol 59, 876, 2006.
    • (2006) J Clin Epidemiol , vol.59 , pp. 876
    • Heckerling, P.S.1
  • 46
    • 35549001383 scopus 로고    scopus 로고
    • Stable ethics: Enrolling non-treatmentrefractory volunteers in novel gene transfer trials
    • Kimmelman, J. Stable ethics: enrolling non-treatmentrefractory volunteers in novel gene transfer trials. Mol Ther 15, 1904, 2007.
    • (2007) Mol Ther , vol.15 , pp. 1904
    • Kimmelman, J.1
  • 47
    • 61349126697 scopus 로고    scopus 로고
    • First-in-human trial participants: Not a vulnerable population, but vulnerable nonetheless
    • Dresser, R. First-in-human trial participants: not a vulnerable population, but vulnerable nonetheless. J Law Med Ethics 37, 38, 2009.
    • (2009) J Law Med Ethics , vol.37 , pp. 38
    • Dresser, R.1
  • 48
    • 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, R.M. Target populations for first-in-human embryonic stem cell research in spinal cord injury. Cell Stem Cell 8, 468, 2011.
    • (2011) Cell Stem Cell , vol.8 , pp. 468
    • Bretzner, F.1    Gilbert, F.2    Baylis, F.3    Brownstone, R.M.4
  • 51
    • 0041706886 scopus 로고    scopus 로고
    • Misunderstanding in clinical research: Distinguishing therapeutic misconception, therapeutic misestimation, and therapeutic optimism
    • Horng, S., and Grady, C. Misunderstanding in clinical research: distinguishing therapeutic misconception, therapeutic misestimation, and therapeutic optimism. IRB 25, 11, 2003.
    • (2003) IRB , vol.25 , pp. 11
    • Horng, S.1    Grady, C.2
  • 53
    • 57949108871 scopus 로고    scopus 로고
    • Therapeutic misconception
    • Emonuel, E.J., Grady, C., Crouch, R.A., Lie, R., Miller, F.G., and Wendler, D. New York: Oxford University Press
    • Appelbaum, P.S., and Lidz, C.W. Therapeutic misconception. In: Emonuel, E.J., Grady, C., Crouch, R.A., Lie, R., Miller, F.G., and Wendler, D. The Oxford Textbook of Clinical Research Ethics, New York: Oxford University Press, 2008, pp. 633-644.
    • (2008) The Oxford Textbook of Clinical Research Ethics , pp. 633-644
    • Appelbaum, P.S.1    Lidz, C.W.2
  • 54
    • 0029927575 scopus 로고    scopus 로고
    • The impact of disease severity on the informed consent process in clinical research
    • Schaeffer, M.H., Krantz, D.S., Wichman, A., Masur, H., Reed, E., and Vinicky, J.K. The impact of disease severity on the informed consent process in clinical research. Am J Med 100, 261, 1996.
    • (1996) Am J Med , vol.100 , pp. 261
    • Schaeffer, M.H.1    Krantz, D.S.2    Wichman, A.3    Masur, H.4    Reed, E.5    Vinicky, J.K.6
  • 55
    • 12844261878 scopus 로고    scopus 로고
    • The therapeutic misconception: Problems and solutions
    • Lidz, C.W., and Appelbaum, P.S. The therapeutic misconception: problems and solutions. Med Care 40, V55, 2002.
    • (2002) Med Care , vol.40 , pp. V55
    • Lidz, C.W.1    Appelbaum, P.S.2
  • 57
    • 18444390927 scopus 로고    scopus 로고
    • Elements of style: Consent form language and the therapeutic misconception in phase 1 gene transfer trials
    • Kimmelman, J., and Levenstadt, A. Elements of style: consent form language and the therapeutic misconception in phase 1 gene transfer trials. Hum Gene Ther 16, 502, 2005.
    • (2005) Hum Gene Ther , vol.16 , pp. 502
    • Kimmelman, J.1    Levenstadt, A.2
  • 58
    • 84856546785 scopus 로고    scopus 로고
    • Therapeutic misconception and stem cell research
    • Cho, M.K., and Magnus, D. Therapeutic misconception and stem cell research. Nat Reports Stem Cells 2007.
    • (2007) Nat Reports Stem Cells
    • Cho, M.K.1    Magnus, D.2
  • 59
    • 84864561670 scopus 로고    scopus 로고
    • Unnecessary holes in the head
    • Gillett, G.R. Unnecessary holes in the head. IRB 23, 1, 2001.
    • (2001) IRB , vol.23 , pp. 1
    • Gillett, G.R.1
  • 60
    • 44349144442 scopus 로고    scopus 로고
    • Human stem cell ethics: Beyond the embryo
    • Sugarman, J. Human stem cell ethics: beyond the embryo. Cell Stem Cell 2, 529, 2008.
    • (2008) Cell Stem Cell , vol.2 , pp. 529
    • Sugarman, J.1
  • 61
    • 52449089653 scopus 로고    scopus 로고
    • Informing participants in clinical trials with ex vivo human tissueengineered products: What to tell and how to tell it?
    • Trommelmans, L., Selling, J., and Dierickx, K. Informing participants in clinical trials with ex vivo human tissueengineered products: what to tell and how to tell it? J Tissue Eng Regen Med 2, 236, 2008.
    • (2008) J Tissue Eng Regen Med , vol.2 , pp. 236
    • Trommelmans, L.1    Selling, J.2    Dierickx, K.3
  • 62
    • 84858010940 scopus 로고    scopus 로고
    • Stem cell based therapy - Where are we going?
    • Ilic, D., and Polak, J. Stem cell based therapy - where are we going? Lancet 379, 877, 2012.
    • (2012) Lancet , vol.379 , pp. 877
    • Ilic, D.1    Polak, J.2
  • 63
    • 84874789879 scopus 로고    scopus 로고
    • Preventive therapy
    • Editorial
    • Editorial. Preventive therapy. Nature 494, 147, 2013.
    • (2013) Nature , vol.494 , pp. 147
  • 64
    • 84911896580 scopus 로고    scopus 로고
    • Ethical issues in regenerative medicine
    • Wake Forest University Research Paper Series in Legal Studies Working Paper no.1380162 abstract1380162
    • King, N.M., Coughlin, C.N., and Furth, M.E. Ethical Issues in Regenerative Medicine, Wake Forest University Research Paper Series in Legal Studies Working Paper no.1380162; Wake Forest Intellectual Property Journal 2009, electronic copy: http://SSIN.com abstract1380162
    • Wake Forest Intellectual Property Journal 2009, Electronic Copy
    • King, N.M.1    Coughlin, C.N.2    Furth, M.E.3
  • 65
    • 65649147929 scopus 로고    scopus 로고
    • Medicine. A history lesson for stem cells
    • Wilson, J.M. Medicine. A history lesson for stem cells. Science 324, 727, 2009.
    • (2009) Science , vol.324 , pp. 727
    • Wilson, J.M.1
  • 66
    • 78549285936 scopus 로고    scopus 로고
    • The challenge of regenerative medicine
    • Trommelmans, L. The challenge of regenerative medicine. Hastings Cent Rep 40, 24, 2010.
    • (2010) Hastings Cent Rep , vol.40 , pp. 24
    • Trommelmans, L.1
  • 67
    • 84876947844 scopus 로고    scopus 로고
    • Regenerative medicine techniques in cardiovascular disease: Where is the horizon?
    • Packer, C., Boddice, B., and Simpson, S. Regenerative medicine techniques in cardiovascular disease: where is the horizon? Regen Med 8, 351, 2013.
    • (2013) Regen Med , vol.8 , pp. 351
    • Packer, C.1    Boddice, B.2    Simpson, S.3
  • 68
    • 34548720511 scopus 로고    scopus 로고
    • Commercial development of stem cell technology: Lessons from the past, strategies for the future
    • Martin, P.A., Coveney, C., Kraft, A., Brown, N., and Bath, P. Commercial development of stem cell technology: lessons from the past, strategies for the future. Regen Med 1, 801, 2006.
    • (2006) Regen Med , vol.1 , pp. 801
    • Martin, P.A.1    Coveney, C.2    Kraft, A.3    Brown, N.4    Bath, P.5
  • 69
    • 77952524214 scopus 로고    scopus 로고
    • Stem cell tourism and the power of hope
    • Murdoch, C.E., and Scott, C.T. Stem cell tourism and the power of hope. Am J Bioeth 10, 16, 2010.
    • (2010) Am J Bioeth , vol.10 , pp. 16
    • Murdoch, C.E.1    Scott, C.T.2


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