Cell-based interventions for neurologic conditions: Ethical challenges for early human trials

Neurology

Volumn 71, Issue 4, 2008, Pages 288-293

  Mathews, D J H ^a,l   Sugarman, J ^a   Bok, H ^a   Blass, D M ^a   Coyle, J T ^b   Duggan, P ^a   Finkel, J ^a   Greely, H T ^c   Hillis, A ^a   Hoke, A ^a   Johnson, R ^a   Johnston, M ^d   Kahn, J ^e,f   Kerr, D ^a   Kurtzberg, J ^a   Liao, S M ^a   McDonald, J W ^d   McKhann, G ^a   Nelson, K B ^g   Rao, M ^h   Regenberg, A ^a   Siegel, A W ^a   Smith, K ^a   Solter, D ⁱ   Song, H ^a   Vescovi, A ^j   Young, W ^k   Gearhart, J D ^a   Faden, R ^a   more..

^a JOHNS HOPKINS UNIVERSITY   (United States)

^b HARVARD MEDICAL SCHOOL   (United States)

^c STANFORD UNIVERSITY   (United States)

^d KENNEDY KRIEGER INSTITUTE   (United States)

^e UNIVERSITY OF MINNESOTA   (United States)

^f DUKE UNIVERSITY MEDICAL CENTER   (United States)

^g NATIONAL INSTITUTES OF HEALTH   (United States)

^h INVITROGEN CORPORATION   (United States)

ⁱ MAX PLANCK INSTITUTE OF IMMUNOBIOLOGY AND EPIGENETICS   (Germany)

^j UNIVERSITY OF MILANO BICOCCA   (Italy)

^k RUTGERS UNIVERSITY   (United States)

^l NONE   (United States)

more..

Author keywords

[No Author keywords available]

Indexed keywords

BIOETHICS; CELL TRANSPLANTATION; CENTRAL NERVOUS SYSTEM; CLINICAL RESEARCH; CLINICAL TRIAL; EMBRYONIC STEM CELL; HUMAN; INFORMED CONSENT; LAW; MEDICAL ETHICS; NEUROLOGIC DISEASE; NONHUMAN; PATIENT SAFETY; POLITICS; PRIORITY JOURNAL; RESEARCH SUBJECT; REVIEW; RISK ASSESSMENT; STEM CELL TRANSPLANTATION; ANIMAL; BIOLOGICAL THERAPY; BRAIN DISEASE; ETHICS; FOOD AND DRUG ADMINISTRATION; MEDICAL RESEARCH; METHODOLOGY; NEUROLOGY; PROFESSIONAL STANDARD; STANDARD; TIME; UNITED STATES;

ANIMALS; BIOMEDICAL RESEARCH; BRAIN DISEASES; CLINICAL TRIALS AS TOPIC; CLINICAL TRIALS DATA MONITORING COMMITTEES; ETHICS COMMITTEES, RESEARCH; HUMANS; NEUROLOGY; RISK ASSESSMENT; STEM CELL TRANSPLANTATION; TIME FACTORS; TISSUE THERAPY; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 50549094908     PISSN: 00283878     EISSN: 1526632X     Source Type: Journal    
DOI: 10.1212/01.wnl.0000316436.13659.80     Document Type: Review

References (45)

1. Stem Cells Inc. Stem cells: press releases. Available at: http://www.stemcellsinc.com/news/pressreleases.html. Accessed July 15, 2006.
2. Ramirez-Montealegre D, Rothberg PG, Pearce DA. Another disorder finds its gene. Brain 2006;129:1353-1356.
3. ReNeuron Group plc. ReNeuron News. Available at: http://www.reneuron.com/ programmes/stroke. Accessed January 25, 2008.
4. Athersys Inc. Athersys Inc media and investor information. Available at: http://www.athersys.com/Home/Product-Candidates/MultiStemforStroke/tabid/75/ Default.aspx. Accessed January 25, 2008.
5. Brainstorm Cell Therapeutics Inc. Press releases. Available at: http://www.brainstorm-cell.com/Index.asp?ArticleID = 153&CategoryID = 76&Page = 2. Accessed January 25, 2008.
6. Geron Corporation. Geron press releases. Available at: http://www.geron.com/showpage.asp?code = prodst. Accessed January 25, 2008.
7. Living Cell Technologies. LCT - Living Cell Technologies - Biotechnology in Australia, Italy, New Zealand, USA. Available at: http://www.lct.com.au/ media-lct.php. Accessed July 15, 2006.
8. Dodd ML, Klos KJ, Bower JH, Geda YE, Josephs KA, Ahlskog JE. Pathological gambling caused by drugs used to treat Parkinson disease. Arch Neurol 2005;62:1377-1381.
9. Temel Y, Kessels A, Tan S, Topdag A, Boon P, Visser-Vandewalle V. Behavioural changes after bilateral subthalamic stimulation in advanced Parkinson disease: a systematic review. Parkinsonism Relat Disord 2006;12: 265-272.
10. Berney A, Vingerhoets F, Perrin A, et al. Effect on mood of subthalamic DBS for Parkinson's disease: a consecutive series of 24 patients. Neurology 2002;59:1427-1429.
11. Bejjani BP, Damier P, Arnulf I, et al. Transient acute depression induced by high-frequency deep-brain stimulation. N Engl J Med 1999;340:1476-1480.
12. Kulisevsky J, Berthier ML, Gironell A, Pascual-Sedano B, Molet J, Pares P. Mania following deep brain stimulation for Parkinson's disease. Neurology 2002;59:1421-1424.
13. Fann JR, Roth-Roemer S, Burington BE, Katon WJ, Syr-jala KL. Delirium in patients undergoing hematopoietic stem cell transplantation. Cancer 2002;95:1971-1981.
14. Syrjala KL, Dikmen S, Langer SL, Roth-Roemer S, Abrams JR. Neuropsychologic changes from before transplantation to 1 year in patients receiving myeloablative allogeneic hematopoietic cell transplant. Blood 2004;104: 3386-3392.
15. Ni XS, Ouyang J, Zhu WH, Wang C, Chen B. Autologous hematopoietic stem cell transplantation for progressive multiple sclerosis: report of efficacy and safety at three yr of follow up in 21 patients. Clin Transplant 2006;20: 485-489.
16. Dawson L, Bateman-House AS, Mueller Agnew D, et al. Safety issues in cell-based intervention trials. Fertil Steril 2003;80:1077-1085.
17. Greene M, Schill K, Takahashi S, et al. Ethics: moral issues of human-non-human primate neural grafting. Science 2005;309:385-386.
18. Berger J, Moser HW, Forss-Petter S. Leukodystrophies: recent developments in genetics, molecular biology, pathogene-sis and treatment. Curr Opin Neurol 2001;14:305-312.
19. Lu JF, Lawler AM, Watkins PA, et al. A mouse model for X-linked adrenoleukodystrophy. Proc Natl Acad Sci USA 1997;94:9366-9371.
20. Friese MA, Montalban X, Willcox N, Bell JI, Martin R, Fugger L. The value of animal models for drug development in multiple sclerosis. Brain 2006;129:1940-1952.
21. Steinman L, Zamvil SS. How to successfully apply animal studies in experimental allergic encephalomyelitis to research on multiple sclerosis. Ann Neurol 2006;60:12-21.
22. Gilman S. Pharmacologic management of ischemic stroke: relevance to stem cell therapy. Exp Neurol 2006;199:28-36.
23. Maitra A, Arking DE, Shivapurkar N, et al. Genomic alterations in cultured human embryonic stem cells. Nat Genet 2005;37:1099-1103.
24. Pannetier M, Feil R. Epigenetic stability of embryonic stem cells and developmental potential. Trends Biotechnol 2007;25:556-562.
25. Rugg-Gunn PJ, Ferguson-Smith AC, Pedersen RA. Status of genomic imprinting in human embryonic stem cells as revealed by a large cohort of independently derived and maintained lines. Hum Mol Genet 2007;16 Spec No. 2:R243-251.
26. Andrews PW, Benvenisty N, McKay R, et al. The International Stem Cell Initiative: toward benchmarks for human embryonic stem cell research. Nat Biotechnol 2005;23: 795-797.
27. Institute of Medicine (US). Committee on Establishing a National Cord Blood Stem Cell Bank Program. Meyer EA, Hanna KE, Gebbie KM. Cord blood: establishing a national hematopoietic stem cell bank program. Washington, DC: National Academies Press, 2005.
28. American Association of Tissue Banks. Standards for Tissue Banking, 11th Edition. McLean, VA: AATB, 2006.
29. Committee on Guidelines for Human Embryonic Stem Cell Research. Guidelines for Human Embryonic Stem Cell Research. Washington, DC : National Research Council, National Academy of Sciences, 2005.
30. Tilley BC, Palesch YY, Kieburtz K, et al. Optimizing the ongoing search for new treatments for Parkinson disease: using futility designs. Neurology 2006;66:628-633.
31. Schwid SR, Cutter GR. Futility studies: spending a little to save a lot. Neurology 2006;66:626-627.
32. Greene PE, Fahn S. Status of fetal tissue transplantation for the treatment of advanced Parkinson disease. Neuro-surg Focus 2002;13:e3.
33. Olanow CW, Goetz CG, Kordower JH, et al. A double-blind controlled trial of bilateral fetal nigral transplantation in Parkinson's disease. Ann Neurol 2003;54:403-414.
34. Lindvall O, Bjorklund A. Cell therapy in Parkinson's disease. NeuroRx 2004;1:382-393.
35. World Medical Association. World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects. Available at: http://www. wma.net/e/policy/b3.htm. Accessed July 15, 2007.
36. Wolinsky H. The battle of Helsinki: two troublesome paragraphs in the Declaration of Helsinki are causing a furor over medical research ethics. EMBO Rep 2006;7:670-672.
37. Smith L, Byers JF. Gene therapy in the post-Gelsinger era. JONAS Healthc Law Ethics Regul 2002;4:104-110.
38. Shevell MI. Ethics of clinical research in children. Semin Pediatr Neurol 2002;9:46-52.
39. O'Lonergan TA, Milgrom H. Ethical considerations in research involving children. Curr Allergy Asthma Rep 2005; 5:451-458.
40. Kopelman LM, Murphy TF. Ethical concerns about federal approval of risky pediatric studies. Pediatrics 2004; 113:1783-1789.
41. Meade CD. Improving understanding of the informed consent process and document. Semin Oncol Nurs 1999; 15:124-137.
42. Sugarman J, McCrory DC, Hubal RC. Getting meaningful informed consent from older adults: a structured literature review of empirical research. J Am Geriatr Soc 1998; 46:517-524.
43. Altman LK. The doctor's world; publicity and medicine: the human factors. The New York Times: January 1, 1985.
44. Ankney RN. False Hope: A Historical Review of Magazine Coverage of the First Artificial Heart Transplant. Chapel Hill, NC: University of North Carolina, Chapel Hill, 1999.
45. Broad WJ. Dr. Clark's heart: a story of modern marketing as well as modern medicine. The New York Times: March 20, 1983.