Benefits, risks and ethical considerations in translation of stem cell research to clinical applications in Parkinson’s disease

Journal of Medical Ethics - Tập 33 Số 3 - Trang 169-173 - 2007
Zubin Master1, Marcus McLeod2, Ivar Mendez3
1W. Maurice Young Centre for Applied Ethics, University of British Columbia, Vancouver, British Columbia, Canada V6T 1Z2
2Dalhousie University#TAB#
3Cell Restoration Laboratory

Tóm tắt

Stem cells are likely to be used as an alternate source of biological material for neural transplantation to treat Parkinson’s disease in the not too distant future. Among the several ethical criteria that must be fulfilled before proceeding with clinical research, a favourable benefit to risk ratio must be obtained. The potential benefits to the participant and to society are evaluated relative to the risks in an attempt to offer the participants a reasonable choice. Through examination of preclinical studies transplanting stem cells in animals and the transplantation of fetal tissue in patients with Parkinson’s disease, a current set of potential benefits and risks for neural transplantation of stem cells in clinical research of Parkinson’s disease are derived. The potential benefits to research participants undergoing stem cell transplantation are relief of parkinsonian symptoms and decreasing doses of parkinsonian drugs. Transplantation of stem cells as a treatment for Parkinson’s disease may benefit society by providing knowledge that can be used to help determine better treatments in the future. The risks to research participants undergoing stem cell transplantation include tumour formation, inappropriate stem cell migration, immune rejection of transplanted stem cells, haemorrhage during neurosurgery and postoperative infection. Although some of these risks are general to neurosurgical transplantation and may not be reduced for participants, the potential risk of tumour formation and inappropriate stem cell migration must be minimised before obtaining a favourable potential benefit to risk calculus and to provide participants with a reasonable choice before they enrol in clinical studies.

Từ khóa


Tài liệu tham khảo

10.1056/NEJM200103083441002

10.1002/ana.10720

10.1001/jama.283.20.2701

Department of Health and Human Services, National Institutes of Health, Office for Protection from Research Risks. Code of Federal Regulations title 45 Public Welfare part 46 Protection of human subjects 2001.

Levine RJ. Ethics and regulation of clinical research. 2nd edn. New Haven, CT: Yale University Press, 1986:42–57.

Report and recommendations of the National Bioethics Advisory Commission. Assessing risks and potential benefits and evaluating vulnerability. In: Ethical and policy issues in research involving human participants. Bethesda, MD: National Bioethics Advisory Commission, 2001:69–96.

10.1111/j.1748-720X.2000.tb00686.x

1987, N Engl J Med, 317, 41

2002, J Neurosurg, 96, 589, 10.3171/jns.2002.96.3.0589

10.1093/brain/122.6.1121

10.1038/nature00900

10.1172/JCI200521137

10.1176/appi.ajgp.13.10.844

10.1097/00006123-199309000-00034

10.1073/pnas.022438099

2004, Cell Transplant, 13, 535, 10.3727/000000004783983729

1999, IRB, 21, 1

10.1016/j.neuroimage.2003.08.030

2000, AJNR Am J Neuroradiol, 21, 290

10.1093/brain/122.2.219

10.1111/j.1535-7597.2004.43007.x

10.1016/j.proghi.2004.04.001

2005, Can J Neurol Sci, 32, 194, 10.1017/S0317167100003966

10.1016/S0963-6897(97)00121-8

10.1001/archpsyc.61.4.412

10.1111/j.1748-720X.1996.tb01859.x

1982, Drug Inf J, 16, 10, 10.1177/009286158201600102

10.1111/j.1748-720X.2002.tb00721.x

10.1056/NEJM199909233411312

1992, Mov Disord, 7, 2