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Stem cells

Picture Stem cells

Stem cells have recently become a highly debated research area. Stem cells are immature cells that are able to divide to either reproduce (create new immature cells) or produce daughter cells that develop into a specific tissue or organ. Stem cells have the ability to replace cells and tissue that is damaged or diseased; it can be said that in developed individuals, they comprise the body's 'spare part' material. This research area is thus extremely promising. Over the past 40 years, much important knowledge on stem cells has been gained through animal research, primarily on mice. Human stem cells are now of increasing interest to researchers (source: Swedish National Council on Medical Ethics - SMER, 2003).

Research is performed primarily on fertilized eggs left over from test-tube fertilization, which has resulted in a focus on the question of the embryo's moral status. In Sweden, research on fertilized eggs is allowed up to 14 days after fertilization, after which the eggs must be destroyed (The Genetic Integrity Act - SFS 2006:35). Researchers, however, also wish to develop and use stem cell sequences from adults. Another worry is that therapeutic cloning (the creation of embryonic stem cells for medical treatment using somatic nuclear transfer) will lead to the creation of new human beings (reproductive cloning).

Somatic nuclear transfer

Somatic nuclear transference means, expressed simply, that one exchanges the genetic material in a cell. This can mean that an unfertilized egg that has had its nucleus removed is filled with a nucleus from a body cell from the patient being treated. The egg has been donated by a woman to be used for this purpose. The synthetic cell is induced to begin dividing to form an embryo, but that development is interrupted at the stage at which the stem cells are harvested and the continued development into an embryo stops. It is not a question of fertilization in its usual meaning, as the egg with its new nucleus contains a complete set of genes.

Concerning treatment purposes, the stem cells produced through somatic nuclear transference are intended to be administered to the person from whom the cell nucleus is obtained. The treatment itself is the same as for stem cells in general, but as in this method the stem cells have been "copied" with the help of the individual's own cells, they don't run as high a risk of being rejected as would stem cells from another source (source: Dir. 2002:58 from Socialdepartementet - the Swedish social department).

The Swedish standards

In Sweden, the law (SFS 2006:351), states that it be allowed to perform research on fertilized eggs for aims other than test-tube fertilization. With the condition that the research has been approved in advance through an ethics examination, it should be possible to perform somatic nuclear transfer with the aim of researching stem cells for the treatment of the sick. The new law will not only apply to fertilized eggs but also to eggs resulting from somatic nuclear cell transfer. Such eggs should only be created after proper informed consent.

It was also put in place an unambiguous ban on human reproductive cloning, as well as a ban on profit-driven giving, receiving or negotiating of cells or cell sequences that are traceable to a donator. No change to the transplantation law as regards the commercial handling of human biological material is made, but the question is being considered further. It was said, however, that, in certain cases of biological material taken from living people for reasons other than transplantatin, an ethical examination replace the earlier law's demand for the National Board of Health and Welfare's permission.

The law does not ban the creation of embryos for research by the fusing of egg and sperm (see the proposition). Thus, Sweden will be required to register a dissenting opinion on Article 18.2 of the Convention on Human Rights and Biomedicine, which forbids this, in the case of Sweden ratifying the convention. An even stricter position can be found in the European Parliament's resolution on human cloning from the year 2000.

See further "föreskrifter och allmänna råd om användning av vävnader och celler i hälso- och sjukvården och vid klinisk forskning - SOSFS 2009:32" from the National Board of Health and Welfare.

European position

In Europe, the EU has not financed research on stem cells due to a moratorium from 31 December 2003. In its 18th Policy Briefing, as well as in a report on regenerative medicine, the European Science Foundation discusses this question, as has the European Group on Ethics in Science and New Technologies to the European Commission (EGE), also in relation to FP7. At present, funds from the 7th research program may in the EU be used for research on existing stem cells only. FP7 will allow EU funding of projects involving human embryonic stem cells derived from supernumerary embryos, i.e. embryos left over from in vitro fertilisation, which will be examined by independent ethical experts on a case-by-case basis. The latest statement is the Reflection paper on stem cell-based medicinal products from the European Medicines Agency.

European countries have a diverse range of regulations. For example, in the UK, scientists are permitted to carry out research on stem cells derived from human embryos, while therapeutic cloning is partly banned in France and Germany. A discussion point is that work done in one country which is forbidden in another exposes those undertaking this work to the risk of criminal liability. For now, there is no easy solution to this dilemma. In the USA universities performing embryonic stem cell research have an Embryonic Stem Cell Research Oversight Committee (ESCRO) set up to review such research.

Universal ban?

During 2003, a number of United Nations countries attempted to push through a ban on cloning, including work with stem cells. In December, however, the General Assembly decided to postpone a vote on cloning for one year. In October 2004 a coalition of 125 scientific and patients' groups in an open letter urged the UN to reject a global ban on stem cell research. In March 2005 a non-binding declaration calling on nations to ban all forms of cloning was approved by the UN's General Assembly. The wording of the declaration is deliberately vague, however: "member states are called upon to prohibit all forms of human cloning inasmuch as they are incompatible with human dignity and the protection of human life".

Organisations

Standpoints and discussion contributions have been offered by a number of institutions and bodies, such as the Nordic Committee on Bioethics within the Nordic Council of Ministers and, for example, the American Society of Human Genetics: Statement on Stem Cell Research (2001) and Stem Cell Research and Applications: Monitoring the Frontiers of Biomedical Research, by the American Association for the Advancement of Science and the Institute for Civil Society. Suggested Guidelines for Stem Cell Research and Clinical Translation have been proposed by The International Society for Stem Cell Research. See their other position papers here. Two other organisations that have issued codes of conduct are The European Human Embryonic Stem Cell Registry och The International Stem Cell Forum. Hugo have issued a Statement on Stem Cell Research. In a resolution, the World Medical Association has expressed itself on The Non-Commercialisation of Human Reproductive Material, and in a statement it addressed embryonic stem cell research.

In recent times, a number of promising techniques have been developed for creating stemcells that does not involve the use of eggs and embryos. This area of research holds the promise that therapeutic uses of stemcells may be possible without raising such moral dilemmas as has hitherto been the case, and perhaps more funding will become available for stem cell research.

Last updated: 2020-04-12

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