BioWorld International Correspondent

LONDON - The UK regulator has agreed to the generation of human/animal hybrid embryos for stem cell research, paving the way for it to consider two applications for licenses to conduct such research.

The move follows from extensive and lengthy deliberations, and a series of open consultations. The meeting at which the regulator, the Human Fertilisation and Embryology Authority (HFEA) made the decision was held publicly.

Two research teams, at Newcastle University and King's College, London, have applied for permission to make hybrids, which involves fusing an adult human cell nucleus with the shell of an enucleated animal egg. Scientists hope the technique will help make up for the shortage of human eggs that are available for stem cell research.

In accordance with a long-standing law, any embryos created through this method would have to be destroyed after 14 days.

Although any embryonic stem cells derived via that route could not be used in human therapies, researchers have argued that they will provide useful disease models and will be applied in drug discovery. Others have said that use of animal eggs would allow cloning techniques to be refined and improved without wasting the scarce resource of human eggs.

The decision is a success for UK scientists who launched a campaign to have the research approved after the government indicated at the end of last year that it was likely to be banned.

The HFEA stressed the elaborate nature of its consultation, saying the decision presented a particular challenge given that such research is so novel in legal, scientific and ethical terms. "Having looked at all the evidence the authority has decided that there is no fundamental reason to prevent cytoplasmic hybrid research."

However, public opinion in the UK remains finely divided, with people generally opposed to the research unless it is tightly regulated and is likely to lead to scientific or medical advancements.

The HFEA added, "This is not a total green light for cytoplasmic hybrid research, but recognition that this area of research can, with caution and careful scrutiny, be permitted." Individual researchers will be allowed to attempt the creation of cytoplasmic hybrid embryos if they can demonstrate to an HFEA license committee that the research is "necessary and desirable" and meets the overall standards required by the authority for embryo research.

The HFEA said it expects to rule on the two standing applications in November.

Aisling Burnand, chief executive of the UK BioIndustry Association (BIA), said, "'The BIA welcomes the HFEA's decision to support the use of cutting-edge science in the battle against unmet medical need. [We] hope that the government amends its bill to take note of this decision by the HFEA."

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