20 May 2008   |   Viewpoint

Translating the promise

The controversy over embryonic stem cell research will not dissipate until the technology proves itself in the clinic. Now the regulators have to move, say Science|Business’s Nuala Moran.

Nuala Moran, Science|Business Senior Editor.

The UK Parliament voted this week to sanction attempts to generate human/animal hybrid embryos for use in embryonic stem cell research.

The move is intended to try and overcome the shortage of human eggs, the main barrier to progress in embryonic stem cell research. Scientists will be licensed to take enucleated animal eggs and use the standard cloning technique of injecting in the nucleus of a human cell, and then inducing it to start dividing to form an embryo.

Although their research is as yet unpublished for peer review, scientists at Newcastle University in the UK claimed in April to have created such human/animal hybrid embryos using enucleated cow eggs. These survived for three days; the UK law says any embryos thus generated must be destroyed within two weeks.

Cell lines produced from hybrid embryos cannot be used in human therapies, but they are expected to be extremely useful as disease models and for toxicity testing in drug discovery.

In addition, it is hoped that practising the cloning technique with animal eggs will allow researchers to develop the manual dexterity they need to make better use of the human eggs that are available.

After a media debate that generated more heat than light, and with the words Frankenstein Science hanging in the air, UK members of Parliament took the view that the moral and ethical dilemmas surrounding hybrid embryo research are overridden by the potential of the therapies that may be developed as a result.

Investors pile in

One immediate beneficiary was the UK cell therapy company ReNeuron plc, which saw its share price surge by 50 per cent (though it has to be said the movement was modest in real terms – from 8 pence to 12 pence) as investors piled into the stock on the back of the vote.

As the company itself was quick to note, its products are based on foetal, and not embryonic, stem cell lines.

But ReNeuron also took the opportunity to point out that the vote this week needs to be viewed as a platform to move foetal and embryonic stem cell therapies into human trials. Welcoming the decision to approve research on stem cells derived from human animal hybrid embryos, Michael Hunt, Chief Executive Officer of ReNeuron said, “Our hope is that the UK’s reputation for supporting such pioneering early stage stem cell research will be mirrored by further support for later stage, translational research activities […..] to harness the immense potential of stem cells and convert them into safe and effective treatments for patients suffering from the many debilitating diseases that stem cells have the potential to treat or even cure.”

Waiting for the FDA

The problem facing ReNeuron is that it cannot get permission to stage a clinical trial of its lead product, a treatment for stroke. In March this year it received a further no-go from the FDA, more than a year after the product was first put on hold in January 2007. In the interim, the company carried out more preclinical research and submitted the new data. As the company’s chief scientific officer John Sinden said at the time, “Of course you can never say never in terms of risk. It just isn’t possible to prove everything preclinically.”

Just last week, Geron Corporation, the company leading the race to get the first embryonic stem cell therapy into clinical trials, hit the same setback when the FDA said it was putting its treatment for spinal cord injury on hold. After four years of discussion with the FDA, Geron is understandably disappointed.

So where to go from here? There seems little reason to wage furious debates as has happened in the UK and many other countries, over embryonic and foetal stem cell research if the regulators won’t allow products developed as result to be tested in the clinic.

ReNeuron is proceeding with its US application, but at the same time is looking to other regulators, including those in the UK and Australia for permission. At some point – maybe under pressure from patient groups – trials must be sanctioned.

Now it is time to put the focus on getting products that have emerged into clinical trials, and proving (or not) the value of foetal and embryonic stem cell therapies. Until that happens there is little point in continuing to push the ethical and moral boundaries and stirring controversy over what is, and what is not allowed, in basic research.

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