The ethical challenge of stem cell research.

This article analyzes the ethical issues raised by embryonic stem cell research and recent recommendations by the National Bioethics Advisory Commission (NBAC) regarding federal support for this research. The authors identify the key ethical issue as the moral significance that should be granted to early embryos and discuss arguments supporting the diverse answers to that question and the implications each view has on the formulation of rules and policies for stem cell research. The authors conclude that several of NBAC's recommendations regarding the derivation of stem cells from embryos for research are ethically justifiable and sound public policy.     

Our cells/ourselves: creating human embryos for stem cell research.

In September 1999, the National Bioethics Advisory Commission (NBAC) submitted its report, "Ethical issues in human stem cell research." The report recommends federal funding for stem cell research involving human embryos remaining after infertility treatment. It also suggests that at some later time, it may be appropriate for there to be federal funding for this same research using embryos expressly created for research purposes. This essay compares this recommendation to a similar recommendation reached 5 years earlier by the Human Embryo Research Panel of the National Institutes of Health. The NBAC recommendation is found to be much better packaged relative to the (contentious) goal of securing federal funding for this type of research. The merits of this goal are not discussed here. Instead, disappointment is expressed with the absence of any serious discussion of the ethical issues raised by the future possibility of stem cell research using research embryos. The report's silence on this question is significant given its promise to promote public debate on the profound ethical issues regarding human stem cell research.     

人胚胎干细胞建系研究中的伦理管理

目的：建立国人胚胎干细胞系递交国际干细胞库,并在此基础上建立既符合中国国情又得到国际认可的相关伦理管理体系。方法：在比尔盖茨基金会的资助下,与北京大学生命科学院再生生物学实验室合作,募集胚胎建立人胚胎干细胞系,在此过程中探讨可行的符合国际伦理原则的相关伦理管理机制。结果：成功建立了国人胚胎干细胞系及相关伦理管理体系。结论：进行干细胞研究时应充分重视伦理问题,国际干细胞伦理管理与中国相关伦理原则是可以有机结合的。     

人胚胎干细胞建系研究中的伦理管理

目的：建立国人胚胎干细胞系递交国际干细胞库,并在此基础上建立既符合中国国情又得到国际认可的相关伦理管理体系。方法：在比尔盖茨基金会的资助下,与北京大学生命科学院再生生物学实验室合作,募集胚胎建立人胚胎干细胞系,在此过程中探讨可行的符合国际伦理原则的相关伦理管理机制。结果：成功建立了国人胚胎干细胞系及相关伦理管理体系。结论：进行干细胞研究时应充分重视伦理问题,国际干细胞伦理管理与中国相关伦理原则是可以有机结合的。     

Stem cell research: licit or complicit? Is a medical breakthrough based on embryonic and fetal tissue compatible with Catholic teaching?

In November 1998 biologists announced that they had discovered a way to isolate and preserve human stem cells. Since stem cells are capable of developing into any kind of human tissue or organ, this was a great scientific coup. Researchers envision using the cells to replace damaged organs and to restore tissue destroyed by, for example, Parkinson's disease, diabetes, or even Alzheimer's. But, since stem cells are taken from aborted embryonic and fetal tissue or "leftover" in vitro embryos, their use raises large ethical issues. The National Institutes of Health (NIH) recently decided to fund research employing, not stem cells, but "cell lines" derived from them. The NIH has essentially made an ethical determination, finding sufficient "distance" between cell lines and abortion. Can Catholic universities sponsoring biological research agree with this finding? Probably not. In Catholic teaching, the concept of "complicity" would likely preclude such research. However, Catholic teaching would probably allow research done with stem cells obtained from postpartum placental tissue and from adult bone marrow and tissue. These cells, which lack the pluripotency of embryonic and fetal stem cells, are nevertheless scientifically promising and do not involve the destruction of human life.     

Health charities, unethical research and organizational integrity

Organizations, particularly Catholic hospitals, schools and social service agencies, should re-examine their relationships to health and medical charities promoting unethical research such as human embryonic stem cell research and therapeutic cloning. Part 6 of the Ethical and Religious Directives provides a helpful framework for ethical analysis and action.     

干细胞研究进展及相关伦理学问题思考

始于上世纪末,迄今仍方兴未艾的干细胞研究,由于其特殊的细胞分化,组织再生,甚至可能的器官再造特性,引起了又一次生物医学革命,被视为20世纪末最重要的生物医学成就。但同时由于胚胎干细胞涉及的人类胚胎生命及组织、器官的再生成等伦理学问题,干细胞研究从问世的第一天起,就在生物医学家、哲学家、法学家、政治家间引起广泛的争论。文章简要复习了近年来干细胞研究成果及干细胞研究引起的相关伦理学争论,并就干细胞研究引发的伦理学问题及对未来医疗发展的影响提出作者的观点。     

Ethical boundary-work in the embryonic stem cell laboratory

Most accounts of the ethics of stem cell research are de- contextualised reviews of the ethical and legal literature. In this chapter we present a socially embedded account of some of the ethical implications of stem cell research, from the perspectives of scientists directly involved in this area. Based on an ethnography of two leading embryonic stem cell laboratories in the UK, our data form part of the findings from a larger project mapping the scientific, medical, social and ethical dimensions of innovative stem cell treatment, focusing on the areas of liver cell and pancreatic islet cell transplantation. We explore three key issues: what individual scientists themselves view as ethical sources of human embryos and stem cells; their perceptions of human embryos and stem cells; and how scientists perceive regulatory frameworks in stem cell research. We argue that these dimensions of laboratory practice are all examples of 'ethical boundary-work', which is becoming an integral part of the routine practice and performance of biomedical science. Our work adds to the relatively few sociological studies that explore ethics in clinical settings and to an even smaller body of work that explores scientists' views on the ethical issues relating to their research.     

Embryo futures and stem cell research: the management of informed uncertainty

In the social worlds of assisted conception and stem cell science, uncertainties proliferate and particular framings of the future may be highly strategic. In this article we explore meanings and articulations of the future using data from our study of ethical and social issues implicated by the donation of embryos to human embryonic stem cell research in three linked assisted conception units and stem cell laboratories in the UK. Framings of the future in this field inform the professional management of uncertainty and we explore some of the tensions this involves in practice. The bifurcation of choices for donating embryos into accepting informed uncertainty or not donating at all was identified through the research process of interviews and ethics discussion groups. Professional staff accounts in this study contained moral orientations that valued ideas such as engendering patient trust by offering full information, the sense of collective ownership of the National Heath Service and publicly funded science and ideas for how donors might be able to give restricted consent as a third option.     

Die Kriterien der Hochrangigkeit, der hinreichenden Vorklärung und der „Alternativlosigkeit“ nach § 5 Stammzellgesetz aus ethischer Sicht

The German Stem Cell Act forbids, in principle, the importation und use of human embryonic stem cells, but provides for exceptions under specific conditions. It is the first Federal German law that grants an ethical review authority over the approval process. The legislature has indeed established the criteria for the work of the members of the "Central Ethics Commission for Stem Cell Research" appointed by the Federal Government. The three criteria include the following: 'high priority of the research goals', sufficiencyy of research in the animal and adult human models' and 'the absence of an alternative'. Together they legitimate the importation and use of human embryonic stem cells. This paper seeks to elucidate these three criteria, to analyze their dual function as ethical and as scientific concepts, and to illustrate the ways in which they are being used.     

Ethical Aspects of the Use of Stem Cell Derived Gametes for Reproduction

A lot of interest has been generated by the possibility of deriving gametes from embryonic stem cells and bone marrow stem cells. These stem cell derived gametes may become useful for research and for the treatment of infertility. In this article we consider prospectively the ethical issues that will arise if stem cell derived gametes are used in the clinic, making a distinction between concerns that only apply to embryonic stem cell derived gametes and concerns that are also relevant for gametes derived from adult stem cells. At present, it appears preferable to use non-embryonic stem cells for the derivation of gametes. Adult stem cell derived gametes do not present any problems with regard to the moral status of the human embryo, bypass the safety risks linked to SCNT and do not present any ambiguity or novel problems with regard to informed consent, psychological consequences for the child or genetic parenthood. A remaining ethical concern, however, regards the safety of the procedure in terms of the welfare of the resulting children. This should spark a thorough reflection on how far one must go to accommodate a person’s wish to have a genetically related child.     

Fresh or frozen? Classifying ‘spare’ embryos for donation to human embryonic stem cell research

United Kingdom (UK) funding to build human embryonic stem cell (hESC) derivation labs within assisted conception units (ACU) was intended to facilitate the 'In-vitro fertilisation (IVF)-stem cell interface', including the flow of fresh 'spare' embryos to stem cell labs. However, in the three sites reported on here, which received this funding, most of the embryos used for hESC research came from long term cryopreservation storage and/or outside clinics. In this paper we explore some of the clinical, technical, social and ethical factors that might help to explain this situation. We report from our qualitative study of the ethical frameworks for approaching women/couples for donation of embryos to stem cell research. Members of staff took part in 44 interviews and six ethics discussion groups held at our study sites between February 2008 and October 2009. We focus here on their articulations of social and ethical, as well as scientific, dimensions in the contingent classification of 'spare' embryos, entailing uncertainty, fluidity and naturalisation in classifying work. Social and ethical factors include acknowledging and responding to uncertainty in classifying embryos; retaining 'fluidity' in the grading system to give embryos 'every chance'; tensions between standardisation and variation in enacting a 'fair' grading system; enhancement of patient choice and control, and prevention of regret; and incorporation of patients' values in construction of ethically acceptable embryo 'spareness' ('frozen' embryos, and embryos determined through preimplantation genetic diagnosis (PGD) to be genetically 'affected'). We argue that the success of the 'built moral environment' of ACU with adjoining stem cell laboratories building projects intended to facilitate the 'IVF-stem cell interface' may depend not only on architecture, but also on the part such social and ethical factors play in configuration of embryos as particular kinds of moral work objects.     

Bioethische und sozialethische Probleme bei der Verwendung von Geweben aus humanen embryonalen Stammzellen sowie der Aufbewahrung von Stammzellen aus dem Nabelschnurblut durch private Firmen zum autologen Gebrauch

The regulation of the European Council and Parliament on advanced therapy medicinal products also includes therapies with human embryonic stem cells. The use of these stem cells is controversially and heavily discussed. Contrary to the use of adult stem cells, medical and ethical problems concerning the use of human embryonic stem cells persists, because this use is based on the destruction of human life at the very beginning. The regulation forsees, therefore, subsidiarity within the European Member States. Although there are no ethical problems in principle with the use of stem cells from the umbilical cord blood, there are social ethical doubts with the banking of these stem cells for autologous use without any currently foreseeable medical advantage by commercial blood banks. Also in this case subsidiarity is valid.     

Fresh or frozen? Classifying ‘spare’ embryos for donation to human embryonic stem cell research

United Kingdom (UK) funding to build human embryonic stem cell (hESC) derivation labs within assisted conception units (ACU) was intended to facilitate the ‘In-vitro fertilisation (IVF)-stem cell interface’, including the flow of fresh ‘spare’ embryos to stem cell labs. However, in the three sites reported on here, which received this funding, most of the embryos used for hESC research came from long term cryopreservation storage and/or outside clinics. In this paper we explore some of the clinical, technical, social and ethical factors that might help to explain this situation. We report from our qualitative study of the ethical frameworks for approaching women/couples for donation of embryos to stem cell research. Members of staff took part in 44 interviews and six ethics discussion groups held at our study sites between February 2008 and October 2009. We focus here on their articulations of social and ethical, as well as scientific, dimensions in the contingent classification of ‘spare’ embryos, entailing uncertainty, fluidity and naturalisation in classifying work. Social and ethical factors include acknowledging and responding to uncertainty in classifying embryos; retaining ‘fluidity’ in the grading system to give embryos ‘every chance’; tensions between standardisation and variation in enacting a ‘fair’ grading system; enhancement of patient choice and control, and prevention of regret; and incorporation of patients’ values in construction of ethically acceptable embryo ‘spareness’ (‘frozen’ embryos, and embryos determined through preimplantation genetic diagnosis (PGD) to be genetically ‘affected’). We argue that the success of the ‘built moral environment’ of ACU with adjoining stem cell laboratories building projects intended to facilitate the ‘IVF-stem cell interface’ may depend not only on architecture, but also on the part such social and ethical factors play in configuration of embryos as particular kinds of moral work objects.     

Registration of Human Embryonic Stem Cell Lines: Korea, 2010

In an effort to increase the credibility of human embryonic stem cell (hESC) lines established in Korea, obligatory registration was introduced by the Bioethics and Safety Act 2008, effective as of January 1, 2010.The DNA fingerprint, chromosome stability, expression of pluripotency markers, and contamination of mycoplasma of the submitted lines were analyzed by Korea Centers for Disease Control and Prevention (KCDC). The characterization data and ethical aspects, such as informed consent for donation of surplus embryos, were reviewed by a 10-member advisory review committee for stem cell registry.A total of 55 domestic hESC lines were submitted for registration in 2010; among them 51 were registered. Among these submitted lines, 26 were additionally characterized by KCDC, while 25 lines previously characterized by the Ministry of Education, Science and Technology were not additionally analyzed by KCDC.Registration completed an oversight system for embryo research by registering the products of licensed embryo research projects, making embryo research more transparent in Korea. Information about hESC lines is available at the website of the Korea Stem Cell Registry (kscr.nih.go.kr).     

Science, Law, and Politics in FDA's Genetically Engineered Foods Policy: Scientific Concerns and Uncertainties

The Food and Drug Administration's (FDA's) 1992 policy statement granted genetically engineered foods presumptive GRAS (generally recognized as safe) status. Since then, divergent views have been expressed concerning the scientific support for this policy. This paper examines four sources to better understand the basis for these claims: 1) internal FDA correspondence; 2) reports from the National Academy of Sciences; 3) research funded by US Department of Agriculture from 1981 to 2002; and 4) FDA's proposed rules issued in 2001. These sources reveal that little research has been conducted on unintended compositional changes from genetic engineering. Profiling techniques now make this feasible, but the new debate centers on the functional meaning of compositional changes.     

诱导多潜能性干细胞的研究现状与临床应用前景

胚胎干细胞可作为细胞替代治疗中很好的供体细胞来源。但由于伦理学的原因,限制了胚胎干细胞在细胞替代治疗中的应用前景,而诱导多潜能性干细胞(induced pluripotent stem cell,iPS细胞)的出现则提供了一种替代胚胎干细胞的多潜能性细胞。因为iPS细胞的建立不需要卵细胞,也不破坏发育中的胚胎,所以iPS细胞不涉及伦理学问题。而且iPS细胞的建立相对简单,重复性好。因此,iPS细胞在细胞替代治疗和再生医学中有着广泛的应用前景。本文将回顾iPS细胞技术发展的历史,介绍现有的建立iPS细胞的不同方法和评估iPS细胞质量的手段,展望iPS细胞在细胞替代治疗上有待解决的问题和应用前景。     

Humane embryonale Stammzellen im Kontext internationaler Forschungsaktivitäten

Research involving pluripotent human embryonic stem cells (hESCs) is a rapidly growing field of science. Since hESCs originate from early human embryos, alternative methods for producing pluripotent cells have been developed. This article introduces some of those strategies and, in addition, covers international efforts to establish consistent international standards for cultivation, characterization and preservation of hESCs. Furthermore, global trends to form networks in the field of stem cell research as well as endeavors to harmonize ethical standards for hESC research are presented. Finally, potential applications of hESCs in the field of pharmacology/toxicology are discussed as well as recent results of animal studies using hESCs.     

Stem cell sources for cardiac regeneration

Cell-based cardiac repair has the ambitious aim to replace the malfunctioning cardiac muscle developed after myocardial infarction, with new contractile cardiomyocytes and vessels. Different stem cell populations have been intensively studied in the last decade as a potential source of new cardiomyocytes to ameliorate the injured myocardium, compensate for the loss of ventricular mass and contractility and eventually restore cardiac function. An array of cell types has been explored in this respect, including skeletal muscle, bone marrow derived stem cells, embryonic stem cells (ESC) and more recently cardiac progenitor cells. The best-studied cell types are mouse and human ESC cells, which have undisputedly been demonstrated to differentiate into cardiomyocyte and vascular lineages and have been of great help to understand the differentiation process of pluripotent cells. However, due to their immunogenicity, risk of tumor development and the ethical challenge arising from their embryonic origin, they do not provide a suitable cell source for a regenerative therapy approach. A better option, overcoming ethical and allogenicity problems, seems to be provided by bone marrow derived cells and by the recently identified cardiac precursors. This report will overview current knowledge on these different cell types and their application in cardiac regeneration and address issues like implementation of delivery methods, including tissue engineering approaches that need to be developed alongside.     

Differentiation of embryonic and adult stem cells into insulin producing cells

Replacement of insulin producing cells represents an almost ideal treatment for patients with diabetes mellitus type 1. Transplantation of pancreatic islets of Langerhans is successful in experienced centers. The wider application of this therapy, however, is limited by the lack of donor organs. Insulin producing cells generated from stem cells represent an attractive alternative. Stem cells with the potential to differentiate into insulin producing cells include embryonic stem cells (ESC) as well as adult stem cells from various tissues including the pancreas, liver, bone marrow and adipose tissue. The use of human ESC is hampered by ethical concerns but research with human ESC may help us to decipher important steps in the differentiation process in vitro since almost all information available on pancreas development are based on animal studies. The present review summarizes the current knowledge on the development of insulin producing cells from embryonic and adult stem cells with special emphasis on pancreatic, hepatic and human mesenchymal stem cells.