메뉴 건너뛰기




Volumn 8, Issue 1, 2013, Pages 65-73

Regenerative medicine interventions for orthopedic disorders: Ethical issues in the translation into patients

Author keywords

clinical trials; comparator; first in human trial; intervertebral disc disease; musculoskeletal; osteoarthritis; outcome measures; participant selection; research ethics; risk:benefit ratio

Indexed keywords

ALLOTRANSPLANTATION; ARTHROSCOPIC SURGERY; AUTOTRANSPLANTATION; CELL THERAPY; CLINICAL RESEARCH; CONTROLLED STUDY; GENE TRANSFER; HUMAN; INTERVERTEBRAL DISK DISEASE; KNEE OSTEOARTHRITIS; MEDICAL ETHICS; MUSCULOSKELETAL DISEASE; ORTHOPEDICS; PRIORITY JOURNAL; REGENERATIVE MEDICINE; REVIEW; RISK BENEFIT ANALYSIS; TISSUE ENGINEERING;

EID: 84871583959     PISSN: 17460751     EISSN: 1746076X     Source Type: Journal    
DOI: 10.2217/rme.12.112     Document Type: Review
Times cited : (22)

References (50)
  • 1
    • 40949165422 scopus 로고    scopus 로고
    • Engineering tissues, organs and cells
    • Atala A. Engineering tissues, organs and cells. J. Tissue Eng. Regen. Med. 1(2), 83-96 (2007).
    • (2007) J. Tissue Eng. Regen. Med , vol.1 , Issue.2 , pp. 83-96
    • Atala, A.1
  • 2
    • 41949139826 scopus 로고    scopus 로고
    • A proposed definition of regenerative medicine
    • Daar AS, Greenwood HL. A proposed definition of regenerative medicine. J. Tissue Eng. Regen. Med. 1(3), 179-184 (2007).
    • (2007) J. Tissue Eng. Regen. Med , vol.1 , Issue.3 , pp. 179-184
    • Daar, A.S.1    Greenwood, H.L.2
  • 3
    • 77953688105 scopus 로고    scopus 로고
    • Cell delivery therapeutics for musculoskeletal regeneration
    • Noth U, Rackwitz L, Steinert AF, Tuan RS. Cell delivery therapeutics for musculoskeletal regeneration. Adv. Drug Deliv. Rev. 62(7-8), 765-783 (2010).
    • (2010) Adv. Drug Deliv. Rev , vol.62 , Issue.7-8 , pp. 765-783
    • Noth, U.1    Rackwitz, L.2    Steinert, A.F.3    Tuan, R.S.4
  • 5
    • 0141920503 scopus 로고    scopus 로고
    • Burden of major musculoskeletal conditions
    • Woolf AD, Pfleger B. Burden of major musculoskeletal conditions. Bull. World Health Organ. 81(9), 646-656 (2003).
    • (2003) Bull. World Health Organ , vol.81 , Issue.9 , pp. 646-656
    • Woolf, A.D.1    Pfleger, B.2
  • 6
    • 69949173320 scopus 로고    scopus 로고
    • An exploratory survey on the views of European tissue engineers concerning the ethical issues of tissue engineering research
    • Trommelmans L, Selling J, Dierickx K. An exploratory survey on the views of European tissue engineers concerning the ethical issues of tissue engineering research. Tissue Eng. Part B Rev. 15(3), 241-247 (2009).
    • (2009) Tissue Eng. Part B Rev , vol.15 , Issue.3 , pp. 241-247
    • Trommelmans, L.1    Selling, J.2    Dierickx, K.3
  • 8
    • 84862196770 scopus 로고    scopus 로고
    • The risk-benefit task of research ethics committees: An evaluation of current approaches and the need to incorporate decision studies methods
    • Bernabe RD, van Thiel GJ, Raaijmakers JA, van Delden JJ. The risk-benefit task of research ethics committees: an evaluation of current approaches and the need to incorporate decision studies methods. BMC Med. Ethics 13(1), 6 (2012).
    • (2012) BMC Med. Ethics , vol.13 , Issue.1 , pp. 6
    • Bernabe, R.D.1    Van Thiel, G.J.2    Raaijmakers, J.A.3    Van Delden, J.J.4
  • 9
    • 73349093137 scopus 로고    scopus 로고
    • The need to explicate the ethical evaluation tools to avoid ethical inflation
    • Bernabe RD, van Thiel GJ, Raaijmakers JA, van Delden JJ. The need to explicate the ethical evaluation tools to avoid ethical inflation. Am. J. Bioeth. 9(11), 56-58 (2009).
    • (2009) Am. J. Bioeth , vol.9 , Issue.11 , pp. 56-58
    • Bernabe, R.D.1    Van Thiel, G.J.2    Raaijmakers, J.A.3    Van Delden, J.J.4
  • 10
    • 0034574910 scopus 로고    scopus 로고
    • The ethical analysis of risk
    • Weijer C. The ethical analysis of risk. J. Law Med. Ethics 28(4), 344-361 (2000).
    • (2000) J. Law Med. Ethics , vol.28 , Issue.4 , pp. 344-361
    • Weijer, C.1
  • 11
    • 56849085824 scopus 로고    scopus 로고
    • Ethical reflections on clinical trials with human tissue engineered products
    • Trommelmans L, Selling J, Dierickx K. Ethical reflections on clinical trials with human tissue engineered products. J. Med. Ethics 34(9), e1 (2008).
    • (2008) J. Med. Ethics , vol.34 , Issue.9
    • Trommelmans, L.1    Selling, J.2    Dierickx, K.3
  • 12
    • 77649194372 scopus 로고    scopus 로고
    • Challenges with advanced therapy medicinal products and how to meet them
    • Schneider CK, Salmikangas P, Jilma B et al. Challenges with advanced therapy medicinal products and how to meet them. Nat. Rev. Drug Discov. 9(3), 195-201 (2010).
    • (2010) Nat. Rev. Drug Discov , vol.9 , Issue.3 , pp. 195-201
    • Schneider, C.K.1    Salmikangas, P.2    Jilma, B.3
  • 13
    • 79955820579 scopus 로고    scopus 로고
    • Prospects of stem cell therapy in osteoarthritis
    • Roberts S, Genever P, McCaskie A, De Bari C. Prospects of stem cell therapy in osteoarthritis. Regen. Med. 6(3), 351-366 (2011).
    • (2011) Regen. Med , vol.6 , Issue.3 , pp. 351-366
    • Roberts, S.1    Genever, P.2    McCaskie, A.3    De Bari, C.4
  • 14
    • 70349820519 scopus 로고    scopus 로고
    • 2009 ISSLS prize winner: Does discography cause accelerated progression of degeneration changes in the lumbar disc: A ten-year matched cohort study
    • Carragee EJ, Don AS, Hurwitz EL, Cuellar JM, Carrino JA, Herzog R. 2009 ISSLS prize winner: does discography cause accelerated progression of degeneration changes in the lumbar disc: a ten-year matched cohort study. Spine (Phila Pa 1976) 34(21), 2338-2345 (2009).
    • (2009) Spine (Phila Pa 1976) , vol.34 , Issue.21 , pp. 2338-2345
    • Carragee, E.J.1    Don, A.S.2    Hurwitz, E.L.3    Cuellar, J.M.4    Carrino, J.A.5    Herzog, R.6
  • 15
    • 13144307091 scopus 로고    scopus 로고
    • Valuing risk: The ethical review of clinical trial safety
    • Kimmelman J. Valuing risk: the ethical review of clinical trial safety. Kennedy Inst. Ethics J. 14(4), 369-393 (2004).
    • (2004) Kennedy Inst. Ethics J , vol.14 , Issue.4 , pp. 369-393
    • Kimmelman, J.1
  • 16
    • 52449089653 scopus 로고    scopus 로고
    • Informing participants in clinical trials with ex vivo human tissue-engineered products: What to tell and how to tell it? J
    • Trommelmans L, Selling J, Dierickx K. Informing participants in clinical trials with ex vivo human tissue-engineered products: what to tell and how to tell it? J. Tissue Eng. Regen. Med. 2(4), 236-241 (2008).
    • (2008) Tissue Eng. Regen. Med , vol.2 , Issue.4 , pp. 236-241
    • Trommelmans, L.1    Selling, J.2    Dierickx, K.3
  • 17
    • 0034573353 scopus 로고    scopus 로고
    • Defining and describing benefit appropriately in clinical trials
    • King NM. Defining and describing benefit appropriately in clinical trials. J. Law Med. Ethics 28(4), 332-343 (2000).
    • (2000) J. Law Med. Ethics , vol.28 , Issue.4 , pp. 332-343
    • King, N.M.1
  • 18
    • 0023319217 scopus 로고
    • False hopes and best data: Consent to research and the therapeutic misconception
    • Appelbaum PS, Roth LH, Lidz CW, Benson P, Winslade W. False hopes and best data: consent to research and the therapeutic misconception. Hastings Cent. Rep. 17(2), 20-24 (1987).
    • (1987) Hastings Cent. Rep , vol.17 , Issue.2 , pp. 20-24
    • Appelbaum, P.S.1    Roth, L.H.2    Lidz, C.W.3    Benson, P.4    Winslade, W.5
  • 20
    • 84894256552 scopus 로고    scopus 로고
    • Are Phase i trials therapeutic? Risk, ethics, and division of labor
    • doi:10. 1111/j.1467-8519(2012)01979. x Epub ahead of print
    • Anderson JA, Kimmelman J. Are Phase I trials therapeutic? Risk, ethics, and division of labor. Bioethics doi:10. 1111/j. 1467-8519. 2012. 01979. x (2012) (Epub ahead of print).
    • (2012) Bioethics
    • Anderson, J.A.1    Kimmelman, J.2
  • 21
    • 84859429242 scopus 로고    scopus 로고
    • Knee replacement
    • Carr AJ, Robertsson O, Graves S et al. Knee replacement. Lancet 379(9823), 1331-1340 (2012).
    • (2012) Lancet , vol.379 , Issue.9823 , pp. 1331-1340
    • Carr, A.J.1    Robertsson, O.2    Graves, S.3
  • 22
    • 30944444368 scopus 로고    scopus 로고
    • A review of the 2001 Volvo Award winner in clinical studies: Lumbar fusion versus nonsurgical treatment for chronic low back pain: A multicenter randomized controlled trial from the Swedish lumbar spine study group
    • Kwon B, Katz JN, Kim DH, Jenis LG. A review of the 2001 Volvo Award winner in clinical studies: lumbar fusion versus nonsurgical treatment for chronic low back pain: a multicenter randomized controlled trial from the Swedish lumbar spine study group. Spine (Phila Pa 1976) 31(2), 245-249 (2006).
    • (2006) Spine (Phila Pa 1976) , vol.31 , Issue.2 , pp. 245-249
    • Kwon, B.1    Katz, J.N.2    Kim, D.H.3    Jenis, L.G.4
  • 23
    • 4544367324 scopus 로고    scopus 로고
    • A fair and balanced view of spine fusion surgery
    • Errico TJ, Gatchel RJ, Schofferman J et al. A fair and balanced view of spine fusion surgery. Spine J. 4(5 Suppl. ), S129-S138 (2004).
    • (2004) Spine J , vol.4 , Issue.SUPPL. 5
    • Errico, T.J.1    Gatchel, R.J.2    Schofferman, J.3
  • 24
    • 67650711512 scopus 로고    scopus 로고
    • Prevalence and pattern of lumbar magnetic resonance imaging changes in a population study of one thousand forty-three individuals
    • Cheung KM, Karppinen J, Chan D et al. Prevalence and pattern of lumbar magnetic resonance imaging changes in a population study of one thousand forty-three individuals. Spine (Phila Pa 1976) 34(9), 934-940 (2009).
    • (2009) Spine (Phila Pa 1976) , vol.34 , Issue.9 , pp. 934-940
    • Cheung, K.M.1    Karppinen, J.2    Chan, D.3
  • 25
    • 79551505767 scopus 로고
    • Potential of magnetic resonance imaging findings to refine case definition for mechanical low back pain in epidemiological studies: A systematic review
    • Endean A, Palmer KT, Coggon D. Potential of magnetic resonance imaging findings to refine case definition for mechanical low back pain in epidemiological studies: a systematic review. Spine (Phila Pa 1976) 36(2), 160-169 (2011).
    • (1976) Spine (Phila Pa) , vol.36 , Issue.2 , pp. 160-169
    • Endean, A.1    Palmer, K.T.2    Coggon, D.3
  • 26
    • 0037293291 scopus 로고    scopus 로고
    • Osteoarthritis: MR imaging findings in different stages of disease and correlation with clinical findings
    • Link TM, Steinbach LS, Ghosh S et al. Osteoarthritis: MR imaging findings in different stages of disease and correlation with clinical findings. Radiology 226(2), 373-381 (2003).
    • (2003) Radiology , vol.226 , Issue.2 , pp. 373-381
    • Link, T.M.1    Steinbach, L.S.2    Ghosh, S.3
  • 27
    • 0035873354 scopus 로고    scopus 로고
    • The Longitudinal Assessment of Imaging and Disability of the Back (LAIDBack) study: Baseline data
    • Jarvik JJ, Hollingworth W, Heagerty P, Haynor DR, Deyo RA. The Longitudinal Assessment of Imaging and Disability of the Back (LAIDBack) study: baseline data. Spine (Phila Pa 1976) 26(10), 1158-1166 (2001).
    • (2001) Spine (Phila Pa 1976) , vol.26 , Issue.10 , pp. 1158-1166
    • Jarvik, J.J.1    Hollingworth, W.2    Heagerty, P.3    Haynor, D.R.4    Deyo, R.A.5
  • 28
    • 0037043268 scopus 로고    scopus 로고
    • Diagnostic evaluation of LBP: Reaching a specific diagnosis is often impossible
    • Deyo RA. Diagnostic evaluation of LBP: reaching a specific diagnosis is often impossible. Arch. Intern. Med. 162(13), 1444-1447 (2002).
    • (2002) Arch. Intern. Med , vol.162 , Issue.13 , pp. 1444-1447
    • Deyo, R.A.1
  • 29
    • 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, Dierickx K. Is tissue engineering a new paradigm in medicine? Consequences for the ethical evaluation of tissue engineering research. Med. Health Care Philos. 12(4), 459-467 (2009).
    • (2009) Med. Health Care Philos , vol.12 , Issue.4 , pp. 459-467
    • Trommelmans, L.1    Selling, J.2    Dierickx, K.3
  • 30
    • 61449150546 scopus 로고    scopus 로고
    • What is the best standard for the standard of care in clinical research?
    • van der Graaf R, van Delden JJ. What is the best standard for the standard of care in clinical research? Am. J. Bioeth. 9(3), 35-43 (2009).
    • (2009) Am J. Bioeth , vol.9 , Issue.3 , pp. 35-43
    • Van Der Graaf, R.1    Van Delden, J.J.2
  • 32
    • 61449266619 scopus 로고    scopus 로고
    • Standard of care in clinical research with human tissue engineered products (HTEPs)
    • Trommelmans L, Dierickx K. Standard of care in clinical research with human tissue engineered products (HTEPs). Am. J. Bioeth. 9(3), 44-45 (2009).
    • (2009) Am. J. Bioeth , vol.9 , Issue.3 , pp. 44-45
    • Trommelmans, L.1    Dierickx, K.2
  • 33
    • 0037352237 scopus 로고    scopus 로고
    • Ethical framework for the use of sham procedures in clinical trials
    • Horng S, Miller FG. Ethical framework for the use of sham procedures in clinical trials. Crit. Care Med. 31(3 Suppl. ), S126-S130 (2003).
    • (2003) Crit. Care Med , vol.31 , Issue.SUPPL. 3
    • Horng, S.1    Miller, F.G.2
  • 34
    • 1242306788 scopus 로고    scopus 로고
    • Sham surgery: An ethical analysis
    • Miller FG. Sham surgery: an ethical analysis. Sci. Eng. Ethics 10(1), 157-166 (2004).
    • (2004) Sci. Eng. Ethics , vol.10 , Issue.1 , pp. 157-166
    • Miller, F.G.1
  • 35
    • 79951696478 scopus 로고    scopus 로고
    • Developing a placebo-controlled trial in surgery: Issues of design, acceptability and feasibility
    • Campbell MK, Entwistle VA, Cuthbertson BH et al. Developing a placebo-controlled trial in surgery: issues of design, acceptability and feasibility. Trials 12, 50 (2011).
    • (2011) Trials , vol.12 , Issue.50
    • Campbell, M.K.1    Entwistle, V.A.2    Cuthbertson, B.H.3
  • 36
    • 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(13), 992-996 (1999).
    • (1999) N. Engl. J. Med , vol.341 , Issue.13 , pp. 992-996
    • MacKlin, R.1
  • 37
    • 69249156419 scopus 로고    scopus 로고
    • Progress and prospects: Genetic treatments for disorders of bones and joints
    • Evans CH, Ghivizzani SC, Robbins PD. Progress and prospects: genetic treatments for disorders of bones and joints. Gene Ther. 16(8), 944-952 (2009).
    • (2009) Gene Ther , vol.16 , Issue.8 , pp. 944-952
    • Evans, C.H.1    Ghivizzani, S.C.2    Robbins, P.D.3
  • 38
    • 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(1), 38-50 (2009).
    • (2009) J. Law Med. Ethics , vol.37 , Issue.1 , pp. 38-50
    • Dresser, R.1
  • 39
    • 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, Brownstone RM. Target populations for first-in-human embryonic stem cell research in spinal cord injury. Cell Stem Cell 8(5), 468-475 (2011).
    • (2011) Cell Stem Cell , vol.8 , Issue.5 , pp. 468-475
    • Bretzner, F.1    Gilbert, F.2    Baylis, F.3    Brownstone, R.M.4
  • 40
    • 57049157621 scopus 로고    scopus 로고
    • Scaffolding in tissue engineering: General approaches and tissue-specific considerations
    • Chan BP, Leong KW. Scaffolding in tissue engineering: general approaches and tissue-specific considerations. Eur. Spine J. 17(Suppl. 4), 467-479 (2008).
    • (2008) Eur. Spine J , vol.17 , Issue.SUPPL. 4 , pp. 467-479
    • Chan, B.P.1    Leong, K.W.2
  • 41
    • 57049099115 scopus 로고    scopus 로고
    • Tissue engineering and the intervertebral disc: The challenges
    • Kandel R, Roberts S, Urban JP. Tissue engineering and the intervertebral disc: the challenges. Eur. Spine J. 17(Suppl. 4), 480-491 (2008).
    • (2008) Eur. Spine J , vol.17 , Issue.SUPPL. 4 , pp. 480-491
    • Kandel, R.1    Roberts, S.2    Urban, J.P.3
  • 42
    • 80053216438 scopus 로고    scopus 로고
    • Adjacent level disk disease-is it really a fusion disease? Orthop
    • viii
    • Lund T, Oxland TR. Adjacent level disk disease-is it really a fusion disease? Orthop. Clin. North Am. 42(4), 529-541, viii (2011).
    • (2011) Clin. North Am , vol.42 , Issue.4 , pp. 529-541
    • Lund, T.1    Oxland, T.R.2
  • 43
    • 57049130901 scopus 로고    scopus 로고
    • Biological repair of the degenerated intervertebral disc by the injection of growth factors
    • Masuda K. Biological repair of the degenerated intervertebral disc by the injection of growth factors. Eur. Spine J. 17(Suppl. 4), 441-451 (2008).
    • (2008) Eur. Spine J , vol.17 , Issue.SUPPL. 4 , pp. 441-451
    • Masuda, K.1
  • 44
    • 70649108638 scopus 로고    scopus 로고
    • Bone morphogenetic proteins in orthopaedic surgery
    • Axelrad TW, Einhorn TA. Bone morphogenetic proteins in orthopaedic surgery. Cytokine Growth Factor Rev. 20(5-6), 481-488 (2009).
    • (2009) Cytokine Growth Factor Rev , vol.20 , Issue.5-6 , pp. 481-488
    • Axelrad, T.W.1    Einhorn, T.A.2
  • 45
    • 70349466527 scopus 로고    scopus 로고
    • From osteoarthritis treatments to future regenerative therapies for cartilage
    • Clouet J, Vinatier C, Merceron C et al. From osteoarthritis treatments to future regenerative therapies for cartilage. Drug Discov. Today 14(19-20), 913-925 (2009).
    • (2009) Drug Discov. Today , vol.14 , Issue.19-20 , pp. 913-925
    • Clouet, J.1    Vinatier, C.2    Merceron, C.3
  • 47
    • 34247216719 scopus 로고    scopus 로고
    • Biological treatment strategies for disc degeneration: Potentials and shortcomings
    • Paesold G, Nerlich AG, Boos N. Biological treatment strategies for disc degeneration: potentials and shortcomings. Eur. Spine J. 16(4), 447-468 (2007).
    • (2007) Eur. Spine J , vol.16 , Issue.4 , pp. 447-468
    • Paesold, G.1    Nerlich, A.G.2    Boos, N.3
  • 49
    • 84859430216 scopus 로고    scopus 로고
    • Tissue engineering of functional articular cartilage: The current status
    • Kock L, van Donkelaar CC, Ito K. Tissue engineering of functional articular cartilage: the current status. Cell Tissue Res. 347(3), 613-627 (2012).
    • (2012) Cell Tissue Res , vol.347 , Issue.3 , pp. 613-627
    • Kock, L.1    Van Donkelaar, C.C.2    Ito, K.3
  • 50
    • 80053384813 scopus 로고    scopus 로고
    • In vivo tissue engineering of musculoskeletal tissues
    • McCullen SD, Chow AG, Stevens MM. In vivo tissue engineering of musculoskeletal tissues. Curr. Opin. Biotechnol. 22(5), 715-720 (2011).
    • (2011) Curr. Opin. Biotechnol , vol.22 , Issue.5 , pp. 715-720
    • McCullen, S.D.1    Chow, A.G.2    Stevens, M.M.3


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.