The news of another breakthrough in Oregon in stem-cell technology the cloning of embryos using human tissues and then the ability to harvest stem cells from them opens up new possibilities in the personalisation of therapeutic cloning. But, closer to home, it serves to draw attention once again to the lacunae in Irish law that have left most of a field of fast-developing research and the whole area of assisted reproduction unregulated, Irish scientists unable to pursue cutting edge science, funding withheld, and potential patients vulnerable to unscrupulous scientists.

Ironically the breakthrough comes as our legislators battle with abortion legislation. Both issues, tied up as they are with thorny ethical issues around where life begins and when and how embryos acquire rights, are equally politically toxic. Both have also been the subject of urgent injunctions from the frustrated courts to politicians to fulfil their responsibility to legislate. Both, crucially, also require a willingness and courage on the part of politicians to move beyond absolutist moral positions to a new legislative ethics based on pluralist values and real social needs .

Having grasped one nettle, abortion legislation, is it too much to ask our politicians to do the same with bioethics stem cell research and provision for assisted reproduction, specifically in-vitro fertilisation (IVF)? Two reports, from the Government- appointed Commission on Assisted Human Reproduction and from the Irish Council for Bioethics, the first going back to 2005, proposed practical, conservative, guidelines for legislation that respect most of the sensitivities around ethical concerns over the production of embryos for research purposes. Crucially, they would limit researchers to using embryos that are surplus to requirements in the IVF process and which would otherwise be discarded/destroyed.

In the interim the Supreme Court in Roche v Roche (2009) has facilitated such legislation by clarifying the point at which it views the foetus as acquiring constitutional protection implantation in the womb. Any earlier and embryonic stem cell research, IVF, and contraceptives based on preventing implantation, including the day-after pill, would have been prohibited. Of course, the absence of a constitutional protection for the early embryo does not mean an easy consensus will be reached. As the abortion debate has shown, many are only too willing to challenge and flatly deny the courts interpretations, but its thoughtful ruling in Roche can provide a coherent rationale for the emerging middle ground of legislators and for carefully limited legislative provision for stem cell research and assisted reproduction.

It understood that legislation is currently being drafted by the Department of Health. It is now long overdue.

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Time to legislate on stem cells

Javascript is currently disabled in your web browser. For full site functionality, it is necessary to enable Javascript. In order to enable it, please see these instructions. 11 hours ago by Merlin Crossley, The Conversation Credit: euthman

In a paper published in Cell yesterday, scientists from the US and Thailand have, for the first time, successfully produced embryonic stem cells from human skin cells.

That sounds interesting, but what are stem cells and where do they come from?

If you take a limb from a rose tree, and put it in soil, it will grow into a thriving bush.

But you might say: "Plants are special. This won't work with animals." Or will it? If you cut off a lizard's tail, a new tail may grow. A lobster can grow back a lost claw.

There is a special type of flatworm that can be cut in half, again and again hundreds of times, and each half grows back into a full worm.

Similarly, if you cut out half a human liver, it will grow back. The story of Prometheus, whose liver was eaten away by eagles and regrew each day, suggests that the Greeks of ancient times knew about regeneration of organs.

This sort of regeneration is attributed to special cells called "stem cells".

Reprogramming the workers

Most of our cells are like many professional workers they are hardened in their ways and can't manage career changes.

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Explainer: What are stem cells?

Newswise The Stem Cell Research Italy Association (www.stemcellitaly.org) and the Sbarro Health Research Organization (www.shro.org) make a public plea for a correct use of stem cell therapy in Italy and Europe.

Stem Cell Research Italy (SCR Italy) strongly endorses the point of view of eminent scientists who published a commentary on the regulation of stem cell therapy in Europe (Bianco et al Regulation of stem cell therapies under attack in Europe: for whom the bell tolls EMBO J. 2013 May 3. doi: 10.1038/emboj.2013.114).

In the present plea SCR quotes the hot topic issues that were addressed in the commentary.

The Italian Parliament is debating a new law that would make it legal to practice an unproven stem cell treatment in public hospitals. The treatment, offered by a private non-medical organization, may not be safe, lacks a rationale, and violates current national laws and European regulations. This case raises multiple concerns, most prominently the urgent need to protect patients who are severely ill, exposed to significant risks, and vulnerable to exploitation.

It must be underlined that stem cells are not a homogeneous class of cells; stem cells are not one-size-fits-all cures. There are different kinds of stem cells in different tissues, and even when the appropriate stem cell is selected for an indication it takes years of research to learn how to administer the stem cell safely and effectively.

Empiricism as a productive approach in medicine is often invoked as a reason to conduct trials with stem cells, blind of any putative mechanism of action.

Conducting formal, regulated, transparent clinical trials using stem cells can be legitimate, even if based on a partial or weak rationale. It is also, however, expensive and highly likely to be uninformative. Scientific approach must be robust before one embarks on a clinical trial. Mechanistic insight is not a dispensable intellectual luxury. It is specifically required to develop effective therapies. It is to this end that we need mechanisms and rationale.

A model of translational medicine has been subliminally accepted by many scientists. The scheme is driven by the pressure to effect the rapid translation of data from the bench. Premature translation of provisional data and concepts in the stem cell field, in conjunction with loosened regulation, can perhaps bring to the market products, but cannot provide solutions for diseases.

On this premise, scientists must clearly inform public opinion and authorities on the potential risks of stem cell therapy to avoid media campaign vowing the right of sick people to have access stem cell therapy for compassionate use. It has to be firmly rejected the argument offered by media and public opinion of a compassionate use of stem cells: there is no compassion without safety and efficacy. Exposing the weakest people to unknown risks is ethically unacceptable. Recourse to unproven and unsafe therapy is said to be compassion, or to fall into an arbitrary category of compassionate treatment. This is not the case at all. Compassion only applies when one offers a safe and potentially effective remedy. That a remedy is effective must be supported by published clinical data. If such data are not available, there is no legitimate assumption of effectiveness in the individual patient, and therefore no compassion.

In conclusion SCR Italy strongly agree with the notion that only rigorous science and rigorous regulation can ensure translation of science into effective therapies rather than into ineffective market products, and mark, at the same time, the sharp distinction between the striving for new therapies and the deceit of patients.

Read more here:
Plea for a Correct Use of Stem Cells in Therapy