Cloning News Review Items listed by date, starting with the most recent: 2004 - current Another loophole in the HFE Act? (July 2004) Mice produced by 'virgin birth' (July 2004) HFEA considers first human cloning project (July 2004) Human clones in South Korea (April 2004) UN Blocks cloning ban (January 2004) 2000 - 2003 Horse Clone (October 2003) First cloned baby claim (April 2003) Law Lords give cloning the all-clear (April 2003) Dolly's death fuels cloning concerns (April 2003) Stem cell progress (April 2003) Dolly's creator turns to humans (January 2003) European Parliament calls for a ban on human cloning (January 2003) MRC announces UK stem cell bank (October 2002) Cloning latest (October 2002) HFEA grants stem cell research licences (July 2002) Outrage at latest human cloning claims (July 2002) Cloning Loophole Exposed (January 2002) Scientists clone first human embryo (January 2002) MPs move to close human cloning loophole (July 2001) Cult plans to clone humans (January 2001) Cloned embryo research a possibility (July 2000) Controversy over US Funding of stem cell research (April 2000) BMA opens door to human reproductive cloning (April 2000) Patents for cloning (April 2000) 1997 - 1999 Human embryos may be cloned for stem cells (October 1999) Cloned calf develops fatal complications (July 1999) US doctors created artificial liver from cloned human cells (July 1999) Cloning update (April 1999) Cloning latest (October 1998) Cloning (July 1998) Worldwide ban on human cloning (July 1997) news index cloning index resource centre July 2004 Another loophole in the HFE Act? The creation of human-animal hybrids falls outside the remit of the Human Fertilisation and Embryology Authority and is currently unregulated in the UK. At least one such experiment has taken place in the UK. A team at Cambridge University fused the nuclei from human adult cells with eggs from Xenopus frogs. The aim of such research is to produce ‘rejuvenated’ human cells that would have the ability to grow into replacement human tissues. Such studies could enable a patient to be treated with cells of their own genetic constitution and circumvents the destruction of human embryos involved in other similar projects. Professor John Gurdon, who led the study, said that the resultant cells ‘did not produce anything that could vaguely be described as an embryo… I cannot imagine any possible way that anybody would object to this on ethical grounds.’ Concerns about regulation of hybrid research were raised by Dr Calum MacKellar of the Scottish Council on Human Bioethics. Suzi Leather, chair of the HFEA, has confirmed that these studies fall outside their remit. Under current legislation the HFEA only regulates hybrid embryos formed by direct fusion of human and animal gametes, or those that have the potential to develop into ‘human beings’. The act outlaws placing a live embryo that is not a human embryo inside a woman. (Times 2004; 1 June, Scientist 2004; 2 June) Mice produced by ‘virgin birth’ Two mice have been created using only cells from female parents for the first time. Scientists at Tokyo University of Agriculture used eggs to make the animals, with no sperm or other male cells. This process is similar to parthenogenesis, in which an egg re-recruits its polar body and becomes the sole source of genetic material for the embryo. Parthenogenesis occurs naturally in some species, but not mammals. It has long been thought impossible in mammals due to the biological phenomenon known as imprinting. During gamete formation in mammals, certain genes necessary for embryo development are shut down with a series of chemical markers, or imprints, some in sperm and others in eggs. Only when sperm and egg meet are all the key genes available. Mammalian parthenotes have been produced, but have not survived more than a few days. The Japanese team circumvented the imprinting barrier by genetically modifying female mice to produce eggs with a more ‘male’ imprinting pattern. The nuclei from modified eggs were then transferred into regular eggs taken from normal mice. With two genomes present, the eggs proceeded to grow and divide. The news has inevitably sparked debate about the future redundancy of men, as well as the potential impact of the technique on reproductive science and fertility treatments. However, like the reproductive cloning technique that produced Dolly the sheep in 1997, parthenogenesis is extremely inefficient at present: only two mice resulted from 457 reconstructed eggs. One was sacrificed for testing whilst the other, named Kaguya, has been allowed to grow into an adult. (New Scientist 2004; 21 April) HFEA considers first human cloning project The Human Fertilisation and Embryology Authority (HFEA) is considering the first licence application to create human clones using cell nuclear transfer. Professor Alison Murdoch’s team at the International Centre for Life in Newcastle intend to create cloned embryos from which they will harvest stem cells. They will also research the use of parthenogenesis. The research is linked to developing treatments for diabetes. Cloning embryos for therapeutic purposes was made legal by the HFE (Research Purposes) Regulations 2001 amendment to the HFE Act. The news has been welcomed by patient groups: Alastair Kent, of the Genetics Interest Group, claimed that millions could potentially be helped by the research. He rejected concerns about the destruction of embryos, saying, ‘It is a matter of balancing the rights and needs of those people who are alive now with a very remote potential future person.’ However, there is strong opposition to the move from a variety of quarters, including pro-life groups. Professor Ian Wilmut, who cloned Dolly the sheep, has also expressed intentions to apply for a human cloning licence. Based at the Roslin Institute in Edinburgh, he would create cloned embryos with motor neurone disease and then destroy them after a few days. The Roslin Institute already holds a licence to use parthenogenesis for the creation of human clones followed by stem cell harvesting. (bbc.co.uk 2004; 21 April, 16 June, hfea.gov.uk 2004; 16 June) April 2004 Human clones in South Korea Scientists in Seoul, South Korea have reportedly cloned 30 human embryos. These embryos have been sustained to the size of 100 cells, the furthest stage of development so far reported in the scientific press. They have simultaneously called for a ban on reproductive cloning. The cloned cells were able to differentiate to give various tissue types, but only one of the embryos yielded pluripotent cells from which a stem cell line could be cultured. Ironically, this embryo had both DNA and egg from the same woman, so was not created in the same way as Dolly the sheep, which had DNA and egg from different animals. The other cloned embryos were thought to contain chromosomal abnormalities. A team in Massachusetts, USA succeeded in creating a cloned embryo last year, but it did not reach the stage at which stem cells could be extracted. The aim of such work - so called 'therapeutic' cloning - is to produce matched tissue types for transplantation into patients with conditions such as diabetes and Parkinson's disease. The lead Korean researcher, Woo Suk Hwang, acknowledged the difficulties in creating embryonic stem cell lines, but maintained that the study demonstrates that it is technically possible to create cloned embryos. Some fear that this development will pave the way to cloning embryos for live birth - an aim that American scientist, Panos Zavos, is pursuing. He visited the UK earlier this year and announced that he had successfully implanted a cloned embryo into a woman. The attempt was later reported to have failed. However, he has so far refused to publish any details of his experiments and serious concerns have been raised about creation of a cloned child, not least because of the risks involved with such cellular manipulation. Dolly the sheep was the result of 277 previous attempts at cloning an animal, and her early death may have been due to premature aging. (New Scientist 2004; 12 February, Reuters 2004; 12 February, Telegraph 2004; 14 February, BMJ 2004; 328:421) January 2004 UN blocks cloning ban The United Nations has rejected calls for a worldwide ban on research into human cloning. The decision came after a close vote, in which the UN General Assembly's legal committee voted 80-79 in favour of an Iranian proposal to delay any decision on a ban for two years. The issue of human cloning has created a division between two groups of member states. One, headed up by the USA, is seeking a ban on all types of cloning. This was also backed by the Nigerian delegation, which expressed concerns that women from Africa would be susceptible to pressure from multinational firms to act as a source of embryos. The other group, led by France and Germany, wants to see reproductive cloning prohibited, but not cloning for biomedical research - so called therapeutic cloning. However the general committee has not had a chance to vote on the two proposals following the acceptance of the Iranian proposal. It is hoped that this delay will buy the organisation time to reach a consensus on the issue. The UK government continues to encourage research into therapeutic cloning because of their highly controversial conviction that it 'offers so many patients and their families the hope of life-saving treatments'. Meanwhile, the European Parliament has voted to use public funds for embryonic stem cell research. Advocates of this research believe it will offer unparalleled opportunities to treat diseases such as Alzheimer's and Parkinson's. They also say that this new funding support will enable them to compete on level terms with scientists in the United States. EU research ministers have yet to make a final decision about the exact details of the proposal. Countries opposed to the public funding, such as Austria, Germany and Portugal, may yet scupper the deal by not giving it final and concrete approval. Embryonic stem cell research is currently legal in Britain and Sweden. (bbc.co.uk 2003; 6 November, Reuters 2003; 7 November, New Scientist 2003; 19 November) October 2003 Horse clone The world's first cloned horse, called Prometea, was born on 28 May - the only one of 328 attempts to make it. The announcement was made by Professor Cesare Galli, the project's leading scientist, based in Cremona, Italy. Following this success, scientists have raised the possibility of creating human clones in a similar fashion, given the comparable nature of the equine and human reproductive systems. DNA tests were performed on the young foal, and these were shown to be identical to the mother, also her twin. The process involved extracting a skin cell and egg from the parent, fusing the two cells and reimplanting the embryo into the uterus. While many clones suffer from genetic defects and physical deformities, Prometea is reported to be in good health. Nevertheless, Prof Galli is being cautious in his assessment that Prometea is unaffected by the cloning process. It is thought that in future, the techniques employed to create Prometea will eventually extend to 'preserving' the characteristics of racehorse champions. Breeders have already been encouraged to freeze the cells of horses that are considered to be outstanding. (Telegraph 2003; 7 August, betterhumans.com 2003; 8 August, Guardian 2003; 7 August) April 2003 First cloned baby claim The world's first cloned human baby, Eve, was born on 26 December 2002, according to Clonaid, the company linked to the Raelian sect. Dr Brigitte Boisselier, Clonaid's chief executive, claimed a clutch of cloned pregnancies with parents of various backgrounds: 'Of the 20 of them I think there are six or seven who are infertile couples, eleven who are parents of a lost child.two single women, one lesbian couple, and one homosexual male.' Five babies were allegedly due before mid February. Eve was reportedly cloned using a skin cell from her 31 year old mother. Scientists have been quick to denounce the claims, believing it unlikely that such a rogue band of researchers have been successful so soon. Calls for independent DNA tests to corroborate the claim have gone unanswered. The 'parents' have apparently taken Eve to Israel, beyond the US courts' jurisdiction, and are reluctant to have tests done because of fears that the child will be taken away from them. Dr Boisselier asserted that she would not prove her credibility at the expense of cloned children and their parents: 'Potential customers of our company have to know that they will always have the priority and I will [not] ask future parents by contract to reveal their identity.There will always be a time to re-establish my reputation.other babies are coming and among them, some will be made public.' The Raelian sect was founded by Frenchman, Claude Vorlihon (alias 'Rael') in 1973 and now boasts a membership of 64,000. Rael claims he was visited by aliens who revealed that they had created human beings using genetic engineering, commissioning him to prepare humanity for their return by teaching a message of sexual freedom and eternal life through science. The Raelians' founding tenet is that humans can achieve immortality by cloning themselves and transferring their consciousness into the newly cloned brains. This will enable the accumulation of knowledge ad infinitum through successive 'generations' of clones such that, 'man's ultimate dream of eternal life.becomes a scientific reality'. Rael has welcomed the publicity created by the cloning claims: 'If it isn't true, it's the most beautiful scientific joke but, in any case, it has allowed us to communicate our messages to the whole planet.' (Daily Mail 2003;30 December, bbc.co.uk 2003;29 January, spuc.org.uk 2003;20 January, www.clonaid.com) Law Lords give cloning the all-clear The Law Lords have unanimously dismissed the appeal of the Pro-Life Alliance (PLA) against the legalisation of therapeutic cloning. The decision means that the Human Fertilisation and Embryology Authority (HFEA) is now free to license experiments using cloned human embryos. The 13 March judgment brings an end to the 'cloning saga' that began in October 2000, when the government proposed amendments to the 1990 Human Fertilisation and Embryology (HFE) Act that would permit therapeutic cloning. The PLA applied for judicial review of these proposals, arguing that the HFE Act could not be interpreted to allow therapeutic cloning; either it set a complete ban on cloning or did not cover cloned embryos at all. They wanted a full Parliamentary discussion of cloning and development of effective primary legislation to govern it. In November 2001 the High Court upheld the PLA's case, effectively leaving cloned embryos ungoverned. In the ensuing hype, with Severino Antinori claiming he would come to England to make cloned children, the government quickly pushed through the Human Reproductive Cloning Bill, which prohibits placing an embryo created 'otherwise than by fertilisation' in a woman. In the Court of Appeal, the government managed to overturn the previous ruling, but all cloning licensing had to be put on hold until the PLA's appeal to the House of Lords had been heard. Now that this last hurdle in the English legal system has been cleared, the government is free to proceed as it desires. This position contrasts with the situation in the US, where the House of Representatives recently passed a bill to ban all forms of human cloning, whether for research or reproduction. The bill even makes importing cloned embryos and using products derived from cloned embryos a criminal offence, with maximum fines of $1 million and ten years in prison. The issue now lies in the Senate, where rival bills also await passage. (prolife.org.uk 2003;14 March, bbc.co.uk 2003;13 March, reuters.com 2003;27 February) Dolly's death fuels cloning concerns Dolly the sheep, the world's first animal to be cloned from an adult cell, has died at the age of six - half the normal life expectancy for a sheep. Her early death raises questions about the long term health implications of reproductive cloning. Previous reports of premature arthritis indicated that Dolly was growing old before her time. The final lung disease that prompted vets to put her down is a common problem in older sheep, particularly those housed inside. Dolly was created by cell nuclear replacement, in which the nuclear DNA from an adult cell is placed in an enucleated egg cell. The egg is then given an electric 'shock', which makes it divide as if fertilised by a sperm. Some scientists argue that since Dolly was created using nuclear DNA from a six year old sheep, she was actually 'genetically' twelve when she died. Further evidence about whether her death was linked to her cloned origins will be very important. 'It will provide further evidence of the dangers inherent in reproductive cloning and the irresponsibility of anybody who is trying to extend such work to humans', commented Professor Richard Gardner from the Royal Society. A full post mortem is being conducted by scientists at the Roslin Institute in Edinburgh, where Dolly was created; any significant findings will be reported. Dolly's Australian counterpart, Matilda, unexpectedly died aged three years, a few weeks before Dolly. Researchers claim it was not due to premature aging. The body has been cremated. (Daily Mail 2003;15 February, spuc.org.uk 2003;7 February) Stem cell progress Scientists in the US have successfully managed to modify human embryonic stem cells genetically. The method is similar to that used to breed 'knock-out' mice, where specific genes are targeted and removed, to provide models of human disease. Researchers at the University of Wisconsin, the first laboratory to create a stem cell line, inactivated specific genes in the cells. Every part of the human genome could be open to such manipulation, making the cells very useful for medical research. Such stem cell lines would supplement, and perhaps largely replace, the knock-out mouse. It is hoped that the manipulated cells will develop into specific cells and tissues for transplantation. Using human knock-out cells could also bypass the need to clone host cells as the genes that cause host-graft reactions could be removed. The use of embryonic stem cells has ethical implications, and many hope that adult stem cells will provide an alternative therapeutic means. A team at the US Institute of Neurological Diseases and Stroke have found that stem cells from bone marrow can develop into brain cells. Autopsies of four women who had received bone marrow transplants from men during their lives, revealed clumps of cells in their brains which contained the Y chromosome. These cells must have come from the donated bone marrow. Eva Mezey, who heads the team, thinks that raw stem cells circulate all the time and are recruited to damaged sites by cell signalling. Finding the specific signalling mechanism will be the next step; it may then be possible to expose adult stem cells to the signals and encourage them to develop into the desired tissue. Similar research from Australia shows that bone marrow stem cells can convert into oligodendrocytes, the cells that make myelin. This may be particularly useful in treating patients with Multiple Sclerosis (MS), although trials in humans will be years away. (Guardian 2003;10 February, New Scientist;20 January, 21 January) January 2003 Dolly's creator turns to humans Professor Ian Wilmut, leader of the team that cloned Dolly the sheep, has announced his intention to clone human embryos for research. At a conference in Berlin in October 2002 he told delegates that his laboratory, at the Roslin Institute near Edinburgh, would apply for a licence from the Human Fertilisation and Embryology Authority (HFEA) within the next six months. The proposed research will use the cell nuclear transfer procedure to make clones of patients with genetic disease. The resulting embryos will then be used to harvest stem cells which, in theory, could replicate indefinitely and act as a target for testing medicines to treat the disease. The process will combine two technologies, animal cloning and human embryonic stem cell cultivation, both of which are still experimental and unreliable. Prof Wilmut's speciality is animal research, and the project will require collaboration with medical researchers and IVF clinics. A limiting factor will be the supply of human eggs; there is already a shortage of eggs for IVF. The group are working on techniques to make the egg collection procedure less invasive than current practice in an attempt to encourage donations. Some have expressed fears that the poor may be exploited to obtain eggs for cloning experiments. Current British law is often thought to have already changed to allow human cloning for such research purposes as this. This is not the case. The ProLife Alliance is still awaiting their appeal of a Court of Appeal judgement against them in January 2002, in which they challenged the law on cloning. The appeal should be heard by the House of Lords in April 2003, and Parliament has assured that no cloning will be licensed before the final outcome. (Guardian 2002;14 October:10, Scotsman 2002;10 October, ProLife Alliance press release 2002;12 October) European Parliament calls for a ban on human cloning Members of the European Parliament voted in favour of a total ban on human cloning on 21 November 2002. An amendment to the existing report on life sciences and biotechnology, which outlines a proposed strategy for member states, was approved by 271 MEPs with 154 voting against. The proposal urges member states to push for a total ban of the practice in their country. The amendment specifically acknowledges the dignity of all human beings, whatever their stage of development, and calls for a universal ban on any form of cloning at the level of the United Nations. The vote was welcomed by pro-life organisations but signifies a clear rejection of the recent proposal put to the UN by France and Germany that sought only to ban cloning to produce babies, leaving the issue of therapeutic cloning for later debate. The UN has been attempting to draw up a convention to 'prevent practices which are contrary to human dignity' for the past year but has now been forced to delay its decision following opposition to the new proposal by a number of groups, including the USA and the Vatican. The Vatican's representative at the UN has stated that so-called therapeutic cloning, using embryos to develop treatments for illnesses such as Alzheimer's and diabetes, is even worse than cloning for reproductive purposes. Archbishop Renato Martino described therapeutic cloning as 'an even more serious offence against human dignity. since it involves human beings who are created in order to be destroyed.' A spokesperson for the German lobby said it was 'regrettable' that a compromise could not be reached on drafting a treaty against cloning human beings while negotiations continued on other forms of cloning. The UK remains the only Western country whose parliament has voted to allow the creation and destruction of cloned embryos for research purposes. (SPUC News Digest 2002; 21 November, Guardian 2002; 20 November, Yahoo! News 2002; 19 November) October 2002 MRC announces UK stem cell bank The Medical Research Council (MRC) has announced that the National Institute for Biological Standards and Control is to set up Europe's first stem cell bank. The UK Stem Cell Bank will be managed by the MRC and based in Hertfordshire. The biotechnology and biological sciences research council will contribute 25% of the cost of the £2.6m contract. It is hoped that the bank will be up and running within a year and it will be responsible for managing existing and new adult, fetal and embryonic stem cell lines that will continue to multiply and survive indefinitely. The facility will supply lines to medical researchers enabling them to work towards using stem cells as possible new treatments for common diseases. The launch of the bank was officially announced at an international stem cell conference - Stem Cells: Prospects for Research and Therapy - on 11 September, the first anniversary of the terrorist attacks in the USA, prompting accusations that the MRC had tried to 'bury the bad news'. The use of stem cells for therapeutic purposes continues to create controversy and criticism. A spokesperson for the ProLife Alliance said: 'Like every caring member of our society we want to see ethical cures for human disease. But this bank will also be harvesting human stem cells from the fetus and the embryo and these can only be obtained through the deliberate destruction of human life.' The discovery that stem cells can also be harvested from adults and have a similar ability to 'transdifferentiate' into other tissues, provides a possible alternative to using stem cells derived from embryos. For a comprehensive review of the latest developments in this field see BMJ 2002; 325:372-376. (Guardian 2002; 29 August, 9 September, BMJ 2002;325:562) Cloning latest In South Korea an investigation has been launched into claims by Clonaid that a woman is two months into pregnancy following implantation of a cloned embryo. South Korea currently has no law banning human cloning. Investigators will instead concentrate on other laws about medical practice that may have been violated by Clonaid. Two draft bills, about cloning and stem cell research, are currently on the fast track for approval by the National Assembly. Meanwhile, Professor Ian Wilmut, whose team created Dolly the cloned sheep, has called for a ban on reproductive human cloning due to the high degree of abnormality. He admitted that 99% of animal cloning attempts ended in failure, whilst the offspring of cloned animals were frequently genetically or physically abnormal. (bbc.co.uk 2002; 12, 26 July, spuc.org.uk 2002; 19 August) July 2002 HFEA grants stem cell research licences UK authorities have granted the first licenses for scientists to conduct research involving the development of human embryonic stem cell lines. In the past researchers have only been licensed to study embryos up to 14 days gestation with the intention of improving fertility treatments. However the Human Fertilisation and Embryo Authority (HFEA) approved applications from two groups, allowing them to produce human embryonic stem cell lines and maintain them long term. One group, based at Edinburgh University, has been licensed to develop embryonic stem cell lines to be used in studies aimed at developing new therapeutic approaches to Parkinson's disease. The other team, from King's College, London, will be able to use stem cells to investigate neural disorders, infertility, and miscarriage. In the past stem cell research has focused on cells from animals or on adult stem cells but the new legislation involves the development of stem cell lines from 'spare' embryos created for infertility treatment. However, the HFEA, which oversees all research related to human fertilisation in the UK, said that its license committee had carefully considered all the scientific, medical and ethical issues of the applications. The licences were granted soon after the House of Lords Select Committee on Stem Cell Research gave the go-ahead for the research uses of human embryos to be further extended. The move has not only received widespread support from the scientific community but has made the UK regulations on the subject more liberal than those in other countries, including the United States. (BMJ 2002; 324:562) Outrage at latest human cloning claims News that controversial Italian fertility expert Severino Antinori may be on the verge of cloning the first human baby has provoked outrage amongst medical groups. Dr Antinori, who runs a clinic in Rome, has been quoted in an Arab newspaper as claiming that one of his patients is eight weeks pregnant with a cloned embryo. Dr Antinori refused to comment but has made no secret of the fact that he hopes to produce a viable cloned embryo in the next two years. He would also not reveal information about the pregnant woman. However, he works with women from around the world and claims to have three or four British women on his shortlist. Cloning humans is currently illegal in Britain although many doctors admit that it is almost inevitable unless there is a worldwide ban. Researchers are also banned from cloning humans in Italy or the US but Antinori is thought to be conducting his experiments in Israel and Cyprus.(Guardian 2002; 7 April, BMJ 2002; 324:868) January 2002 Cloning Loophole Exposed The Government has been forced to rush through emergency legislation to make human cloning illegal in the UK. The decision followed High Court action by the ProLife Alliance, which demonstrated that existing regulations did not outlaw the practice. The ProLife Alliance successfully claimed that organisms created by cell nuclear replacement, the technique used to create Dolly the sheep, were not in fact 'embryos' as defined in the Human Fertilisation and Embryology Act (HFE Act) because they were not created by the fertilisation of an egg by a sperm. In effect, this means that the creation of such embryos, whether for therapeutic stem-cell research or reproductive cloning, is not regulated in the UK. The organisation also warned that the ruling meant that human reproductive cloning based on cell nuclear replacement could potentially be carried out in the United Kingdom. Ministers came under further pressure to ban reproductive cloning outright after controversial Italian fertility doctor, Severino Antinori, said he would come to Britain to exploit the loophole. Secretary of State for Health, Alan Milburn, announced that the government intends to appeal against the High Court ruling. Although the government wants to outlaw human cloning, it is keen to ensure that therapeutic cloning is still permitted. Mr Milburn added that the new law would still permit research for therapeutic purposes using stem cells from embryos created by fertilisation, as well as those created by nuclear transfer. (BMJ 2001;323:1203, Independent 2001;17 November) Scientists clone first human embryo Scientists in America have cloned the first human embryo. The results of the experiment, which the scientists are keen to point out was for therapeutic purposes only, were reported in the Journal of Regenerative Medicine. The embryos were created by placing DNA from human skin cells into an enucleated human ovum. In order to harvest stem cells for medical use an embryo would need to consist of a minimum of 64 cells. However, the most developed embryo in the experiment only grew to six cells having been cultured for a week. The volunteers who provided skin cells to be cloned suffered from a variety of conditions from diabetes to spinal cord injury. They included 40 year old Dr Judson Somerville who was paralysed in a cycling accident. He had hoped that treatment with stem cells might enable him to walk his daughter down the aisle at her wedding. Scientists from the US company Advanced Cell Technology, Massachusetts who carried out the experiment were confident that the results prove that the technique is in fact viable. Vice president Robert Lanza said: 'This work sets the stage for human therapeutic cloning as a potentially limitless source of immune-compatible cells for tissue engineering and transplantation medicine'. The company hopes that stem cells will be used to treat a range of conditions within the next ten years. However, the creation of embryos for research purposes is likely to become illegal in both the US and the UK. The US House of Representatives has voted to make it a criminal offence and it will be prohibited by the emergency legislation recently introduced in the UK. (BMJ 2001;323:1267) July 2001 MPs move to close human cloning loophole The Human Fertilisation and Embryology Act of 1990, designed to prevent the cloning of humans, has already become 'out of date' according to Health Secretary Alan Milburn. The 1990 act defines an embryo as a 'live human embryo where fertilisation is complete', and does not foresee the possibility that a mammal could be produced without an egg needing to be fertilised, using cell nuclear replacement, as demonstrated by the creation of Dolly the sheep in 1997. Although the Human Fertilisation and Embryology Authority currently bans reproductive cloning, there is no legislation to stop it changing its stance. The new law, part of the Government's bill that also restricts insurance companies' use of genetic testing, is designed to send a clear signal to the international community of Britain's opposition to reproductive cloning. (Times 2001; 16 April) January 2001 Cult plans to clone humans US scientists say that little can be done to stop a UFO-worshipping cult from pursuing a plan to clone a human being, after finding it had both the money and the medical knowledge to carry out the act. The 'Raelians' claim to be on the verge of cloning an embryo from cells grafted from a 10-month-old girl who died as a result of a medical mistake. The girls parents are paying $500,000 for the procedure. US law only prevents federal funds being used for human cloning, and has no clear regulations on the work of private groups. Scientists say that a cult is an ideal place for such an operation, because of the large number of women surrogates required due to the high failure rate. The leader of the cult, who calls himself 'Rael' said he had 50 women willing to act in this role. (Guardian 2000; 11 October) July 2000 Cloned embryo research a possibility Present legislation limiting research on human embryos is likely to be loosened following a report by an expert council representing the Nuffield Council on Bioethics. The panel recommended changes to the law to enable the use of cloned embryos to produce human tissue for transplant (Telegraph 2000; 6 April). Currently the Human Fertilisation and Embryology Act 1990 permits the creation of embryos for specific research areas including infertility, contraception, congenital diseases and prenatal diagnosis. The Nuffield report states 'there are no grounds for making a moral distinction between research into diagnostic methods or reproduction, which is permitted under UK legislation, and research into potential therapies, which is not currently permitted'. However, it also emphasises the importance of resisting the inclusion of 'research donation' as a reason for abortion. Furthermore, the Government's commissioned report on human cloning, headed up by Dr Liam Donaldson, is expected to recommend therapeutic cloning, arguing that potential benefits outweigh moral considerations. However, the Society for the Protection of the Unborn Child and other pro-life groups have criticised the composition of bioethics committees, and warn of the slippery slope from therapeutic to reproductive cloning. They are launching a nationwide petition to outlaw human cloning in Britain (Telegraph 2000; 3 April). April 2000 Controversy over US Funding of Stem Cell research The US National Institute of Health is preparing to allow federal funding of research into human pluripotent stem cells, for the first time ever. It is hoping to set up a research group to ensure its guidelines are strictly followed. Stem cells will be derived from human embryos or early fetal tissue. This has caused controversy because the government has previously stated that it does not want to be involved in termination of the life of embryos, and such funding contradicts this. However, stem cells are not embryos, and do not on their own, have the potential to become a person. (BMJ 1999;319:1517) BMA opens door to human reproductive cloning The BMA has released a discussion paper saying that public opposition to reproductive cloning may be based on nothing more than an 'illogical transient fear of new technology'. The paper was discussed at the World Medical Association meeting in Tel Aviv in October 1999. The paper assumes that the potential hazards of cloning by cell nuclear replacement will eventually be overcome. It argues that most people object to human cloning on the grounds that a parent with a sick child might request a clone in order to use the cloned bone marrow to save the life of the existing child. But it asks whether this is any more unethical than the reasons for which many parents have children. 'Do people always have children for the sake of the child itself? In reality... it is more to do with their own wishes and desires... if the child were to be abandoned once the donation had taken place, he or she would have been treated merely as a means, and this would be rightly condemned, but the child would undoubtedly be loved and respected...perhaps even more so for having saved the life of their sibling' (BMJ 1999;319:1023, 16 October). Patents for cloning The first patents for the cloning technology used to make Dolly the sheep have been granted five years after they were filed by the Roslin Institute in Edinburgh. However, the first primate has already been cloned by embryo splitting; this technology reduces or even avoids the potential pitfalls of the Dolly technique (Telegraph 2000; 21 January, Telegraph 2000; 14 January). October 1999 Human embryos may be cloned for stem cells The World Medical Association is planning to discuss cloning of human embryos at its annual general meeting in October. New advances in cloning have been coming so rapidly that a fresh debate is needed. In the UK, the Government has retained a ban on cloning embryos for reproductive purposes, although techniques involving replacement of the cell nucleus in order to clone tissues may be permitted in the future, after more debate. The prospect that human embryos will be routinely cloned has drawn closer because of efforts to develop commercial treatments for a range of ailments, from diabetes to heart disease, by using cloning to generate a patient's own cells and tissue. Current research plans to dismantle early cloned human embryos before 14 days as a source of stem cells. These will then be used to grow tissues for transplant and organ repair, rather than implanting the cloned embryos into a surrogate mother to produce a cloned human. Critics argue that such work marks an important step towards the first cloned baby, and it is not illegal in the US to attempt to clone human beings. Lord Winston has suggested that scientists use spare embryos from IVF treatments (that would otherwise be destined for destruction) for growing human tissues, thus side-stepping the need for actual cloning of new embryos. (BMJ 1999;319:8, 3 July, Telegraph 1999; 18 June, Telegraph 1999; 15 June, Telegraph 1999; 25 June, Telegraph 1999; 1 July) July 1999 Cloned calf develops fatal complications A two month-old calf cloned from genes taken from the ear of an adult cow has died after developing serious heart, lymphoid tissue and blood problems. The cloning process seems to have interfered with the normal genetic functioning of the developing animal and the study seems to lend weight to fears that cloning humans may carry considerable health risks (BMJ 1999;318: 1230, 8 May). US doctors create artificial liver from cloned human cells US doctors have used cloned human cells to create an artificial liver, which is about to begin controlled trials. The prospect of being able to clone any type of cell from a patient, such as brain cells for Alzheimer's disease or muscle tissue for heart repair, is drawing closer. (Daily Telegraph 1999; 6 April). April 1999 Cloning Update In December, Government advisers recommended that human embryos a few days old could be cloned for research purposes only in order to develop treatments based on cloned tissue and organs. This would facilitate the development of treatments for mitochondrial diseases. However, the cloning of human beings for reproductive purposes would be banned. The Human Fertilisation and Embryology Authority (HFEA) has suggested that only cell nucleus replacement techniques should be permitted. Scientists in the US have now successfully managed to harvest stem cells from human embryos. They have also created a variation on a human clone by fusing the nucleus of a human cell with a cow egg. This opens up the possibility of producing stem cells, which have the potential to divide forever, to grow a wide variety of other types of cell that make up the human body. Scientists predict that this research will one day allow brain cells to be harvested and grown to replace those lost in Parkinson's and Alzheimer's disease; muscle tissue and eventually whole organs could be grown (The Telegraph 1998; 11 and 19 November, BMJ 1998; 317:1337 14 November, The Telegraph 1998; 8 and 10 December, BMJ 1998; 317:1613 12 December). Laboratory mice will be used as incubators for human eggs in new experiments in the US. Ovarian tissue from women cleared of ovarian cancer, Hodgkin's Disease or leukaemia will be implanted in the mice, who will then 'grow' human eggs, which will be used to make test-tube babies. This may help to avoid the risk of reintroducing cancer to the patients. The aim is to restore the fertility of young women who have been subjected to chemotherapy and radiotherapy. Similar experiments at Leeds University have shown that ovarian tissue from both cats and humans does begin to grow eggs in mice, although larger host animals (such as rabbits) are needed for the eggs to reach maturity (The Telegraph 1998; 5 November). South Korean scientists claim to have produced a cloned human embryo by removing the nucleus of a donor egg and replacing it with a somatic cell nucleus. The scientists claim that if the egg had been implanted, a human child with the same gene characteristics as the donor would have formed. However, there is much scepticism about the validity of this work (The Telegraph 1998; 17 December). October 1998 Cloning latest An international team in Hawaii has produced more than 50 cloned mice. They injected differentiated cell nuclei into enucleated mouse oocytes, using strontium to activate them. Clones have also been created from clones, indicating that the process does not introduce significant mutations. The new technique could be used to produce herds of transgenic clones whose milk contains human proteins or whose organs are compatible with humans for xenotransplantation. (BMJ 1998;317:298, 1 August) July 1998 Cloning Human Factor IX has been produced at commercial concentrations in the milk of transgenic sheep. Conceivably, the world demand for the protein could be served by only 50 animals. A calf called Mr Jefferson has been produced by nuclear transfer, the same technique used to produce Dolly the sheep. The possibility of transgenic cattle producing large quantities of human therapeutic proteins is not far off. Meanwhile Dolly has produced a lamb, Bonnie, at the Roslin Institute in Edinburgh. Calf and lamb clones from nuclear transfer have been produced in five countries so far. In New Zealand a Friesian-Hereford cross calf called Jill is being hailed as the beginning of an assembly-line of high-producing cattle; and two cloned rams called Thomas and James have fathered their first lambs. (BMJ 1998;316:798;14 March, BMJ 1998;316:646;28 February, BMJ 1998;316:1335;2 May, New Zealand Herald 1998;16 April) July 1997 Worldwide ban on human cloning The European Parliament has called for a worldwide ban on the cloning of human beings but has declined applying a similar ban to animal cloning. However, it has encouraged the European Union to introduce strict guidelines to guarantee human health and safeguard animal species and biodiversity. (Student BMJ 1997; 5:94) Meanwhile, in an editorial in the British Medical Journal, London-based professor of fertility studies Robert Winston has extolled the virtues of the practice. Cloning, he claims, should be seen as an exciting challenge rather than a moral threat, offering prospects for research into fertility treatments, genetic disease, xenotransplantation and the preservation of endangered species. (BMJ 1997; 314:913) news index cloning index resource centre Copyright ©2003 Christian Medical Fellowship Comments, suggestions, information: email webmaster@ethicsforschools.org CMF is a registered charity (No 1039823)