Aspects on properties, use and ethical considerations of embryonic stem cells – A short review

Mammalian embryonic stem cells have the potential to differentiate into all cell types of an adult individual. The culturing of human embryonic stem cells renders possible studies that were previously only available in animal models. Embryonic stem cells constitute a particularly attractive tool for studies of self-renewal, commitment, differentiation, maturation and cell-cell interaction. There is currently considerable hope that studies of embryonic stem cells will lead to new therapies; either by themselves, through cell replacement strategies, or by generating results assisting other fields of research to reach clinical results. There are, however, considerable challenges to be met before embryonic stem cells can be used in large-scale clinical trials.Stem cell research is an area that has given rise to much debate internationally, within science, law and politics as well as within philosophy and ethics. The ethical attitudes expressed in the public debate over stem cell research notably divide over three important distinctions: (1) Reproductive versus therapeutic cloning; (2) Using already existing embryos versus producing new embryos for research purposes; (3) Production of embryos from eggs and sperm versus through somatic-cell nuclear transfer. The potential medical benefits that may result from embryonic stem cell research arguably support a continued development in this area. However, some opponents argue that this research offends the (relative or absolute) moral status of an unborn human. Furthermore, the research would probably prove to be a both time-consuming and very expensive method for treating disease. Thus, the questions arise whom the new technique wouldbenefit and at what cost, if ever developed. This revised version was published online in July 2006 with corrections to the Cover Date.     

Stemming the Tide of Normalisation: An Expanded Feminist Analysis of the Ethics and Social Impact of Embryonic Stem Cell Research

Feminists have indicated the inadequacies of bioethical debates about human embryonic stem cell research, which have for the most part revolved around concerns about the moral status of the human embryo. Feminists have argued, for instance, that inquiry concerning the ethics and politics of human embryonic stem cell research should consider the relations of social power in which the research is embedded. My argument is that this feminist work on stem cells is itself inadequate, however, insofar as it has not incorporated an analysis of disability into its considerations of the ethical and political issues that surround the phenomena. Thus, I consider claims that disability theorists and anti-disability activists have made about the research. I conclude by indicating that stem cell research must be situated within a cultural matrix that operates in the service of normalisation.     

The Scope of Public Discourse Surrounding Proposition 71: Looking Beyond the Moral Status of the Embryo

Human embryonic stem cell research has generated considerable discussion and debate in bioethics. Bioethical discourse tends to focus on the moral status of the embryo as the central issue, however, and it is unclear how much this reflects broader community values and beliefs related to stem cell research. This paper presents the results of a study which aims to identify and classify the issues and arguments that have arisen in public discourse associated with one prominent policy episode in the United States: the 2004 Californian Stem Cell Research and Cures Initiative (also known as Proposition 71). The findings show that public discourse about Proposition 71 is characterised by a broader range of issues than those usually addressed in scholarly publications and public policy documents. While attention to the moral status of the embryo is an important issue in stem cell research, making it the main focus of public discourse has a polarising effect. This also limits opportunities to identify shared values, understand how political alliances are forged, and develop social consensus. Implications for future research and policy are discussed.     

UNCERTAIN TRANSLATION,UNCERTAIN BENEFIT AND UNCERTAIN RISK: ETHICAL CHALLENGES FACING FIRST‐IN‐HUMAN TRIALS OF INDUCED PLURIPOTENT STEM (IPS) CELLS

The discovery of induced pluripotent stem (iPS) cells in 2006 was heralded as a major breakthrough in stem cell research. Since then, progress in iPS cell technology has paved the way towards clinical application, particularly cell replacement therapy, which has refueled debate on the ethics of stem cell research. However, much of the discourse has focused on questions of moral status and potentiality, overlooking the ethical issues which are introduced by the clinical testing of iPS cell replacement therapy. First‐in‐human trials, in particular, raise a number of ethical concerns including informed consent, subject recruitment and harm minimisation as well as the inherent uncertainty and risks which are involved in testing medical procedures on humans for the first time. These issues, while a feature of any human research, become more complex in the case of iPS cell therapy, given the seriousness of the potential risks, the unreliability of available animal models, the vulnerability of the target patient group, and the high stakes of such an intensely public area of science. Our paper will present a detailed case study of iPS cell replacement therapy for Parkinson's disease to highlight these broader ethical and epistemological concerns. If we accept that iPS cell technology is fraught with challenges which go far beyond merely refuting the potentiality of the stem cell line, we conclude that iPS cell research should not replace, but proceed alongside embryonic and adult somatic stem cell research to promote cross‐fertilisation of knowledge and better clinical outcomes.     

ON MORAL INCOHERENCE AND HIDDEN BATTLES: STEM CELL RESEARCH IN ARGENTINA

In this article, the authors focus on Argentina's activity in the developing field of regenerative medicine, specifically stem cell research. They take as a starting point a recent article by Shawn Harmon (published in this journal) who argues that attempts to regulate the practice in Argentina are morally incoherent. The authors try to show first, that there is no such ‘attempt to legislate’ on stem cell research in Argentina and this is due to a number of reasons that they explain. Second, by examining the role played by different values, conflicting legal and moral views, and the influence of various actors, they attempt to show that the legislative silence regarding stem cell research may not necessarily be a manifestation of a legal/moral disconnection but rather a survival strategy for navigating the long and heated battle on the moral status of the embryo and the kind of treatment it deserves.     

Embryos,The Principle of Proportionality,and the Shaky Ground of Moral Respect

The debate concerning the moral permissibility of using human embryos in human embryonic stem cell (hESC) research has long centred on the question of the embryo's supposed right to life. However, in focussing only on this question, many opponents to hESC research have escaped rigorous scrutiny by making vague and unfounded appeals to the concept of moral respect in order to justify their opposition to certain hESC practices. In this paper, I offer a critical analysis of the concept of moral respect, and its use to support the intuitively appealing principle of proportionality in hESC research. I argue that if proponents of this principle are to justify its adoption by appealing to the concept of moral respect, they must explain two things concerning the nature of the moral respect owed to embryos. First, they must explain which particular aspect of the embryo is morally relevant, and why. Second, they must explain why some uses of embryos in research fail to acknowledge what is morally relevant about the embryo, and thereby involve a violation of the moral respect that they are due. I shall show that providing such explanations may be more difficult than it first appears.     

NO ETHICAL BYPASS OF MORAL STATUS IN STEM CELL RESEARCH

Recent advances in reprogramming technology do not bypass the ethical challenge of embryo sacrifice. Induced pluripotent stem cell (iPS) research has been and almost certainly will continue to be conducted within the context of embryo sacrifice. If human embryos have moral status as human beings, then participation in iPS research renders one morally complicit in their destruction; if human embryos have moral status as mere precursors of human beings, then advocacy of iPS research policy that is inhibited by embryo sacrifice concerns renders one morally complicit in avoidable harms to persons. Steps may be taken to address these complicity concerns, but in the final analysis there is no alternative to achieving clarity with respect to the moral status of the human embryo.     

胚胎干细胞技术的研究进展

干细胞可以分为成体干细胞和胚胎干细胞两类,是当前生物医学领域的一个热点。由于干细胞在医学领域有巨大应用前景,世界各国都对此给予了相当的重视;投入大量资金支持本国的科学家从事干细胞的科学研究。目前,干细胞的研究还处于试验室阶段,很多技术难题还没有解决,尤其是胚胎干细胞的不定向分化问题,以及一些伦理方面的争议。宗教界人士和社会论理学方面的人士对于干细胞的研究还有异议。集中论述了胚胎干细胞的研究进展和医学功用。     

EMERGING TECHNOLOGIES AND DEVELOPING COUNTRIES: STEM CELL RESEARCH REGULATION AND ARGENTINA

Given its intimate relationship with the human body and its environment, biotechnology innovation, and more particularly stem cell research innovations as a part thereof, implicate diverse social and moral/ethical issues. This paper explores some of the most important and controversial moral concerns raised by human embryonic stem cell research (and the closely associated field of cloning), focusing on concerns relating to the wellbeing of the embryo and the wellbeing of society (the collective). It then considers how and whether these concerns are dealt with in regulatory instruments in Argentina, a southern developing country, examining in particular whether the values underlying these concerns have been translated into practical and effective rules reflective of the primary moral positions advanced. It concludes that Argentina's current state of stem cell research governance fails to consistently reflect the moral positions that have formed and is inadequate given Argentina's activity in this field.     

The pros and cons of human therapeutic cloning in the public debate

Few issues linked to genetic research have raised as much controversial debate as the use of somatic cell nuclear transfer technology to create embryos specifically for stem cell research. Whereas European countries unanimously agree that reproductive cloning should be prohibited there is no agreement to be found on whether or not research into therapeutic cloning should be permitted. Since the UK took the lead and voted in favour of regulations allowing therapeutic cloning the public debate has intensified on the Continent. This debate reflects the wide spectrum of diverse religious and secular moralities that are prevalent in modern multicultural European democratic societies. Arguments range from putting forward strictly utilitarian views that weight the moral issues involved against the potential benefits that embryonic stem cell research may harbour to considering the embryo as a human being, endowed with human dignity and human rights from the moment of its creation, concluding that its use for research is unethical and should be strictly prohibited. Given the current state of dissension among the various European states, it is difficult to predict whether 'non-harmonisation' will prevail or whether in the long run 'harmonisation' of legislation that will allow stem cell research will evolve in the EU.     

A comment on the Hill–Turney exchange: from normative antagonism to interdisciplinary collaboration

Amniotic fluid-derived stem (AFS) cells were the first non-embryonic source of pluripotent stem cells discussed in Italy. AFS cells have been defined “ethical stem cells”, a socio-technical label denoting an array of cellular reprogramming techniques, biological artifacts, and somatic stem cells which make it possible to obtain pluripotent stem cells while avoiding the use of human embryos. The alleged pluripotent status of these cells triggered a debate in which pluripotency was re-positioned as the most promising feature of stem cells. This debate was characterized by discursive articulations in which the boundary between multipotency and pluripotency was blurred and a discourse on a duopoly of pluripotency (pertaining both to embryonic and non-embryonic stem cells) ensued. Drawing on qualitative discourse analysis of articles in scientific journals and newspapers, this paper explores the cultural meaning and political uses of these discursive articulations in the Italian stem cell research regulation debate. This paper also examines a set of aporias emerging from the attempt to incorporate ethical stances into the biological ontology of ethical stem cells, and the problem of constructing normativities in the biotechnology field.     

Marginalizing Experience: A Critical Analysis of Public Discourse Surrounding Stem Cell Research in Australia (2005�C6)

Over the past decade, stem cell science has generated considerable public and political debate. These debates tend to focus on issues concerning the protection of nascent human life and the need to generate medical and therapeutic treatments for the sick and vulnerable. The framing of the public debate around these issues not only dichotomises and oversimplifies the issues at stake, but tends to marginalise certain types of voices, such as the women who donate their eggs and/or embryos to stem cell research and the patients who might benefit from its potential clinical outcomes. This paper draws on empirical research conducted on a recent stem cell policy episode in Australia. From the qualitative examination of 109 newspaper opinion editorials and twenty-three in-depth interviews, it is argued that these voices are marginalised because they are based on discourses that have less epistemological status in public debate. Our results suggest that the personal experiences of women and patients are marginalised by the alliances that form between more powerful discourse communities that use science as a source of authority and legitimation. It is argued that members of these communities establish legitimacy and assert authority in public debate by discursively deploying science in claims that marginalise other epistemologies. Implications are discussed along with suggestions for a more enriched and inclusive public debate.     

关于干细胞临床产业化的一些思考

干细胞的基础研究和临床应用是近几年国内外的热点之一。但是因为没有产业化的明确途径,这个领域的产业化发展缓慢,很有可能像基因治疗和肿瘤疫苗的产业化一样无疾而终。本文探讨了干细胞治疗能够产业化之前需要解决的几个问题。从技术层面,我们比较了胚胎干细胞和成体干细胞,自体干细胞和异体干细胞的优缺点和国内外公司采取的一些途径。从政策方面,我们探讨了把干细胞治疗作为一种医疗技术还是一类医药产品的优缺点,比较了美国FDA和国内监管部门的相关政策,也提出了进一步的问题。最后,我们以美国FDA刚刚批准的Provenge为例,对细胞治疗和干细胞治疗的产业化提出了一些希望和想法。     

干细胞生物工程研究展望

 由于最近两年干细胞研究技术的突破 ,一门崭新的学科“干细胞生物工程”已经形成 .人类胚胎干细胞在体外的成功培养以及一种组织的干细胞 (成体干细胞 )向另一种组织细胞横向分化的发现 ,为利用“干细胞生物工程”技术治疗疾病奠定了基础 .本综述着重介绍干细胞研究领域的一些新概念和新技术以及干细胞分化的基因调控 .对干细胞生物工程的临床应用前景作了概括性讨论     

Derivation of stem cells from human embryos: the principled arguments of potential donors and recipients

Evidence is emerging that embryonic stem cells may have the potential to alleviate many debilitating conditions, but opinions remain polarized on the derivation of stem cells from human embryos obtained during in vitro fertilization treatment. The views of scientists, donors and unaffected members of the general public have been sought, but not those of patients likely to benefit. Semi-structured interviews were completed with 15 people living with Parkinson's disease, 15 with type I diabetes, 15 couples living with infertility and 21 members of the general public. In all four groups, religious, cultural and personal beliefs affected perceptions of the moral status of the embryo and the system of regulating science and scientists involved, overriding differences resulting from their status as potential beneficiaries or facilitators. Whether they came to the interview to defend or promote stem cell research, they cited the same four justifications (utilitarian, ecologic, moral duty and eugenic) but varied in their capacity to present a consistent argument.     

Arrhythmogenic risks of stem cell replacement therapy for cardiovascular diseases

Ischemic heart disease and congestive heart failure are major contributors to high morbidity and mortality. Approximately 1.5 million cases of myocardial infarction occur annually in the United States; the yearly incidence rate is approximately 600 cases per 100,000 people. Although significant progress to improve the survival rate has been made by medications and implantable medical devices, damaged cardiomyocytes are unable to be recovered by current treatment strategies. After almost two decades of research, stem cell therapy has become a very promising approach to generate new cardiomyocytes and enhance the function of the heart. Along with clinical trials with stem cells conducted in cardiac regeneration, concerns regarding safety and potential risks have emerged. One of the contentious issues is the electrical dysfunctions of cardiomyocytes and cardiac arrhythmia after stem cell therapy. In this review, we focus on the cell sources currently used for stem cell therapy and discuss related arrhythmogenic risk.     

Developments in stem cell research and therapeutic cloning: Islamic ethical positions, a review

Stem cell research is very promising. The use of human embryos has been confronted with objections based on ethical and religious positions. The recent production of reprogrammed adult (induced pluripotent) cells does not - in the opinion of scientists - reduce the need to continue human embryonic stem cell research. So the debate continues. Islam always encouraged scientific research, particularly research directed toward finding cures for human disease. Based on the expectation of potential benefits, Islamic teachings permit and support human embryonic stem cell research. The majority of Muslim scholars also support therapeutic cloning. This permissibility is conditional on the use of supernumerary early pre-embryos which are obtained during infertility treatment in vitro fertilization (IVF) clinics. The early pre-embryos are considered in Islamic jurisprudence as worthy of respect but do not have the full sanctity offered to the embryo after implantation in the uterus and especially after ensoulment. In this paper the Islamic positions regarding human embryonic stem cell research and therapeutic cloning are reviewed in some detail, whereas positions in other religious traditions are mentioned only briefly. The status of human embryonic stem cell research and therapeutic cloning in different countries, including the USA and especially in Muslim countries, is discussed.     

An ironic reductio for a 'pro-life' argument: Hurlbut's proposal for stem cell research

William Hurlbut, a Stanford University bioethicist and member of the President's Council on Bioethics, recently proposed a solution to the current impasse over human embryonic stem cell research in the United States. He suggested that researchers could use genetic engineering and somatic cell nuclear transfer (i.e. cloning) to develop human 'pseudo-embryos' that have no potential to develop fully into human persons. According to Hurlbut, even thinkers who typically ascribe high moral status to human embryos could approve of destroying these 'pseudo-embryos' for the sake of harvesting human embryonic stem cells. This essay argues, first, that an argument based on the 'paradox of the heap' (an argument that many 'pro-life' thinkers employ in order to defend the notion that human embryos have high moral value from the moment of conception) challenges the ethical legitimacy of Hurlbut's proposal. Second, the paper argues that this conflict may illustrate a reductio ad absurdum for this 'pro-life' argument itself rather than being a problem for Hurlbut's proposal. As a result, the paper challenges the 'pro-life'strategy of arguing that one should respond to uncertainty about the moral status of developing embryos by being morally 'cautious' and granting all human embryos full moral status from the moment of conception. It appears that one is faced with a complex series of choices (about where to draw the moral line between entities that are human persons and entities that are not), and a strict moral 'cautiousness' about this series of choices may ultimately lead to absurdity.     

THE RACE TOWARD ‘ETHICALLY UNIVERSALLY ACCEPTABLE’ HUMAN PLURIPOTENT (EMBRYONIC‐LIKE) STEM CELLS: ONLY A PROBLEM OF SOURCES?

Over the past few years, several proposals aimed at procuring human pluripotent (embryonic‐like) stem cells without involving the destruction of a human embryo have been proposed and widely discussed. This article focuses on a basic aspect of the debate, namely the plausibility of one or more of these new proposals being able to meet the ethical requirements that those who regard the human embryo as sacred have tried to impose on stem cells research in the last ten years. The thesis of the article is that focusing the discussion only on the sources of stem cells has prevented a full understanding of the foundation, meaning and scope of these ethical requirements. To substantiate this thesis, the article takes into consideration two issues: the first has to do with the potential of the cells obtained through some of the new approaches (iPS included), the second (and decisive) with the argument of the ‘indirect complicity’, applied to the use of ‘contaminated’ knowledge.     

Preservation of stem cells

Adult stem cells (hematopoietic and mesenchymal) have demonstrated tremendous human therapeutic potential. Currently, human embryonic stem cells are used principally for understanding development and disease progression but also hold tremendous therapeutic potential. The ability to preserve stem cells is critical for their use in clinical and research applications. Preservation of cells permits the transportation of cells between sites, as well as completion of safety and quality control testing. Preservation also permits the development of a ‘manufacturing paradigm’ for cell therapies, thereby maximizing the number of products that can be produced at a given facility. in this article, we will review modes of preservation and the current status of preservation of hematopoietic, mesenchymal and human embryonic stem cells. Current and emerging issues in the area of stem cell preservation will also be described.