stem cell research paper

T h e Au s t ra lia n Na t iona l Un i ver s it y _______________________________________________________________________________ DEP UTY V IC E C HANC ELLOR (R ES EARCH) C ANBERRA ACT 0200 AUSTRALIA TELEPHONE: +61 2 6125 8487 FACSIMILE: +61 2 6125 5955 EMAIL: (office) DVC.Research@anu.edu.au EMAIL: (direct) John.Hearn@anu.edu.au URL: http://www.anu.edu.au P ROFE SSOR J OHN P. H E ARN Senate Community Affairs Committee – 19th September, 2002 Inquiry into Research involving Embryos and Prohibition of Human Cloning Bill 2002 Witness: Professor John Hearn, Deputy Vice-Chancellor (Research) Australian National University The Report on Human Cloning: scientific, ethical and regulatory aspects of human cloning and stem cell research from the House of Representatives Standing Committee on Legal and Constitutional Affairs was published in August 2001*. In my opinion it remains the most balanced international overview of the field. My comments below relate to human cells and embryos unless otherwise specified. The Standing Committee Report recommended that research be permitted on adult stem cells and on existing stem cell lines. The members voted 6-4 that stored embryos should be utilised in research under tightly regulated conditions. They supported a moratorium on the cloning of embryos by somatic cell nuclear transfer (the “Dolly” procedure) for three years. They recommended a ban on the formation of new embryos for research through in vitro fertilisation (IVF). They also recommended a ban on human reproductive cloning. A major focus of the current debate is on the ethics of using embryos formed by IVF that have been stored frozen until they are discarded, as required by law after five years. The proposal is that a small proportion of the 60,000 embryos in storage in Australia might be used to derive embryonic stem cell lines for basic research in cell biology and the development of therapies. It is unlikely that direct therapeutic applications will be available from embryonic stem cells for five to ten years. In the year since publication of the Report, the following issues have arisen. Science:  Definitions. There has been confusion in references to embryonic stem cells, foetal germ cells and adult stem cells. Embryonic stem cells are derived from the inner cell mass of the 5-7 day old embryo. Foetal germ cells are derived from the 6-10 week old foetus. Adult stem cells are normally derived from post natal and adult stages. Acceptability of cell lines. Existing embryonic stem cell lines were shown to be unacceptable for therapeutic application, although they allow basic research. The reason was that they were grown on mouse “feeder cell layers”, risking the transfer of viruses. A supply of embryonic stem cells that are grown on human feeder cells would therefore be preferable. Recently human feeder cells derived from abortus material were used successfully. Abortus material may not be an essential source since human skin fibroblast cells and other human cell lines may suffice. Adult stem cells. Several research papers have confirmed that adult stem cells derived from bone marrow and other tissue have pluripotent capacity (they can develop into several tissue types under the right conditions). They can become incorporated into nerve, muscle (including heart muscle), and pancreas. These encouraging early results suggest that adult stem cells may be used in the foreseeable future for therapeutic purposes. Embryonic stem cells. Around the world research has proceeded to examine the biochemical signals that influence cell lineage choice. It is still too early to say whether embryonic stem cells or adult    T h e Au s t ra lia n Na t iona l Un i ver s it y _______________________________________________________________________________ stem cells are likely to be the major source of novel understanding or therapies. At this stage it would be prudent to facilitate research on both.  Raising expectations: It is premature to anticipate therapeutic results that will treat patients with Alzheimers, Parkinsons, Diabetes and other disorders. The field is less than five years old. Use of patients in wheelchairs, film stars, and emotional statements from scientists, industry or the media are inappropriate and risk damaging the credibility of research. Somatic cell nuclear transfer (the “Dolly” procedure). A paper published this week in the Proceedings of the National Academy of Sciences by Jaenisch and others shows that one in every twenty-five genes is altered in the course of this procedure, when the nucleus of the adult cell is reprogrammed. Consequently, the risks of abnormalities arising from the cloning of embryos – or in any cell lines derived from these embryos – is high. These findings also help to explain the very low rate of survival among cloned animals using this technique. Intellectual Property. The procedures and potential applications and uses of stem cell biology have been the subject of many patents. Currently a few companies or universities own the patent rights in the field. Many more companies are licenced to develop embryonic stem cells or cloned embryos for research and potential therapies. International. Several European countries, including Britain and France, have legislated to allow research on embryonic stem cells; the deliberate formation of embryos for research through IVF; and the cloning of embryos by somatic cell nuclear transfer. In the USA, Federal funding cannot be used in embryo research in the public sector. In the private sector all of the above procedures are certainly being pursued. Suggested criteria for embryonic stem cell research. The regulatory process proposed under the Australian legislation incorporates a two level review. The first of these is through the local ethical committee and the second through a committee managed by the NH&MRC. Criteria could be refined in order to (i) acknowledge the special status of the human embryo; (ii) restrict use of embryos to embryonic stem cell derivation only (and not pharmacological testing or general experimentation); (iii) prevent the deliberate formation of embryos for research; (iv) restrict numbers used to a minimum; and (v) require evidence that the research cannot be performed on adult stem cells or on existing stem cell lines. The terms for licencing of institutions and individuals could be similarly stringent. Regulation is preferable to legislation in order that developments in research are not inhibited by the need for constant legislative revisions. Public debate. Further public debate should be encouraged as the field develops nationally and internationally. The pace of the science and of international variations in ethical interpretation and regulation will increase. These advances will bring new understanding of the capacities of cell biology and the potentials for new therapies. New discoveries will bring new challenges.   Regulation:    _____________________ * John Hearn was scientific adviser to the Committee. Declaration of interest: John Hearn is an Australian developmental and reproductive biologist. He led the team in the USA that isolated the first primate embryonic stem cells in 1995 (rhesus monkey) and 1996 (marmoset monkey). He does not work on human embryos and has no related commercial interests.