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Journal of Medical Ethics

Volumn 26, Issue 4, 2000, Pages 231-236

Starting clinical trials of xenotransplantation - Reflections on the ethics of the early phase

(1) Welin, S a

a UNIVERSITY OF GOTHENBURG (Sweden)

Author keywords

Clinical trials; Ethics; Risk; Xenotransplantation

Indexed keywords

ARTICLE; CELL TRANSPLANTATION; CONTROLLED STUDY; DYING; HUMAN; INFECTION RISK; LEGAL LIABILITY; MAJOR CLINICAL STUDY; MEDICAL DECISION MAKING; MEDICAL ETHICS; MORTALITY; PANCREAS ISLET TRANSPLANTATION; PATIENT MONITORING; PATIENT SELECTION; RISK ASSESSMENT; VIRUS INFECTION; XENOTRANSPLANTATION;

ALTERNATIVES; ANIMAL ORGANS; BIOMEDICAL AND BEHAVIORAL RESEARCH; DECLARATION OF HELSINKI; GOVERNMENT REGULATION; HEALTH CARE AND PUBLIC HEALTH; MORAL POLICY; REGULATION; RESEARCH SUBJECTS; SELECTION OF SUBJECTS; STANDARDS; THERAPEUTIC RESEARCH;

ANIMALS; CLINICAL TRIALS; ETHICS, MEDICAL; GOVERNMENT REGULATION; HUMAN EXPERIMENTATION; HUMAN RIGHTS; HUMANS; PATIENT SELECTION; RESEARCH SUBJECTS; RETROVIRIDAE INFECTIONS; RISK FACTORS; SOCIAL CONTROL, FORMAL; SWINE; THERAPEUTIC HUMAN EXPERIMENTATION; TRANSPLANTATION, HETEROLOGOUS; ZOONOSES;

EID: 0033865419 PISSN: 03066800 EISSN: None Source Type: Journal
DOI: 10.1136/jme.26.4.231 Document Type: Article

Times cited : (21)

References (29)

1
- 0008400896
- Pig organs are similar enough to human organs; pigs are of approximately the same size as humans and are easy to breed. At the same time, from an evolutionary point of view, pigs are not as close relatives as primates, and the risk of transmission of disease is believed to be considerably lower than from primates.

2
- 0032580312
- New directions for organ transplantation
- (1998) Nature , vol.392 , Issue.SUPPL. , pp. 11-17
- Platt, J.¹

3
- 0002470638
- Clinical islet xenotransplantation - Transplantation of porcine islets into diabetic patients
- Cooper DKC, ed. Xenotransplantation: the transplant of organs and tissues between species. Berlin: Springer
- (1997) , pp. 812-820
- Groth, C.G.¹ Korsgren, O.² Tibell, A.³ Reinholt, F.⁴ Wennberg, L.⁵ Satake, M.⁶

4
- 0032556891
- Last chance to stop and think on risks of xenotransplant
- (1988) Nature , vol.391 , pp. 320-324
- Butler, U.¹

5
- 0008307097

6
- 0031054438
- Infection of human cells by an endogenous retrovirus of pigs
- (1997) Nature Medicine , vol.3 , pp. 282-286
- Patience, C.¹ Takeuchi, Y.² Weiss, R.A.³

7
- 0032427634
- Immunosuppression by retroviruses: Implications for xenotransplantation
- (1988) Annals of New York Academy of Science , vol.862 , pp. 75-86
- Denner, J.¹

8
- 0008406611
- See reference
- , vol.7 , pp. 75

9
- 0032578251
- No evidence of infection with porcine endogenous retrovirus in recipients of porcine islet-cell xenografts
- Patience C, Patton GS, Takeuchi Y, Weiss RA, McClure MO, Rydberg L, No evidence of pig DNA or retroviral infection in patients with short-term extracorporeal connection to pig kidneys. Lancet 1998;352: 699-701.
- (1998) Lancet , vol.352 , pp. 695-699
- Heneine, W.¹ Tibell, A.² Switzer, W.M.³ Sandstrom, P.⁴ Rosales, G.V.⁵ Mathews, A.⁶

10
- 0032578306
- No clear answers on safety of pigs as tissue donor source. Commentary
- (1998) Lancet , vol.352 , pp. 666-667
- Stoye, J.¹

11
- 0033588002
- The XEN 111 Study Group, Otto E. Search for cross-species transmission of porcine endogenous retrovirus in patient treated with living pig tissue
- (1999) Science , vol.285 , pp. 1236-1241
- Paradis, K.¹ Lanford, G.² Long, Z.³ Heneine, W.⁴ Sandstrom, P.⁵ Switzer, W.M.⁶

12
- 0033588348
- Xenografts and retroviruses
- US FDA. Transcript from biological response modifiers committee, xenotransplantation subcommittee. June 3-4 1999. Washington: Millers Reporting Company Inc, 1999.
- (1999) Science , vol.285 , pp. 1221-1222
- Weiss, R.A.¹

13
- 0031907868
- Uncertainty in xenotransplantation: Individual benefit versus collective risk
- (1998) Nature Medicine , vol.4 , pp. 141
- Bach, F.H.¹ Fishman, J.A.² Daniels, N.³ Proimos, J.⁴ Anderson, B.⁵ Carpenter, C.B.⁶

14
- 0008409208
- See reference
- , vol.13 , pp. 142

15
- 0008319666
- See reference 13: Bach et al are thus recommending two moratoriums: one before any clinical trials of xenotransplantation start and one after the first clinical trials-before moving to clinical use. However, it could be extremely difficult to put the proposed second evaluative moratorium into effect - If xenotransplantation is successful and no sign of viral infections appear.

16
- 0031902283
- US FDA to issue new rules on xenotransplantation
- (1998) Nature Medicine , vol.4 , pp. 876
- Novak, K.¹

17
- 0008355621
- Nuffield Council on Bioethics. Animal-to-human transplants: The ethics of xenotransplantation. London: Nuffield Council on Bioethics
- (1996) , pp. 79

18
- 0031929791
- Xenografting: Ethical issues
- (1998) Journal of Medical Ethics , vol.24 , pp. 18-24
- Hughes, J.¹

19
- 0022339019
- Ethical issues raised by research involving xenografts
- (1985) Journal of the American Medcial Associaton , vol.254 , pp. 3339-3343
- Caplan, A.L.¹

20
- 0008356197
- World Medical Assembly Declaration of Helsinki
- May
- (1997) Bulletin of Medical Ethics , pp. 8-9

21
- 0008362998
- This is proposed by the recent Swedish Parliamentary Commission on Xenotransplantation. SOU 1999:120. Stockholm: Socialdepartementet, (Ministry of Health)
- (1999)

22
- 0031952910
- Ethical considerations of clinical trials to prevent vertical transmission of HIV in developing countries
- (1998) Nature Medicine , vol.4 , pp. 1-12
- Zion, D.¹

23
- 0008312071
- For the view that consent is a sufficient condition for recruitment (if there is no risk to others involved) see reference 18: Hughes J: 20.

24
- 0008307098
- This is also a recommendation made by the Nuffield Council on Bioethics. See reference
- , vol.17 , pp. 86

25
- 0008347864
- The case with the poor patients is similar in many ways to other issues of doing clinical research in developing countries.

26
- 0008320826
- This does not hold for bridges. Bridging to obtain a human organ later is meaningless in the clinical setting; in research it may be more acceptable but it imposes other risks on the participants.

27
- 0008362999
- See reference 12: US FDA.

28
- 0030805660
- European Public Concerted Action Group on Biotechnology and the European Public. Europe ambivalent on biotechnology
- (1997) Nature , vol.387 , pp. 845-847

29
- 0004040771
- The ethics of human gene therapy
- New York and Oxford: Oxford University Press
- (1997) , pp. 39
- Walters, L.¹ Palmer, J.G.²

* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.