BioWorld International Correspondent
LONDON - The UK became the first country in Europe to approve a human cloning experiment, granting researchers in Newcastle permission to clone embryos for the extraction of stem cells.
The one-year license clears the way for the Human Embryonic Stem Cell Group at the Centre for Life to attempt to produce clones by replacing the nucleus of an unfertilized human egg with the nucleus of an adult skin cell, and then inducing it to divide. The eggs to be used were extracted for use in in vitro fertilization, but rejected as unsuitable because they failed to be fertilized by sperm. Under the UK's therapeutic cloning legislation, informed consent of the donors would be required for the research.
The therapeutic focus of the Stem Cell Group is the treatment of diabetes by growing replacement islet cells. Led by Miodrag Stojkovic, reader in embryology and stem cell biology, and Alison Murdoch, professor of reproductive medicine, and the group initially will have to show that eggs with substituted nuclei can be induced to divide and that stem cells can be extracted and cultured.
To date, the only verified account of human cloning was done by scientists at Seoul National University in South Korea. They produced 30 early embryos, but it remains unclear if any stem cell lines have been derived from those.
Murdoch said that in the six months since submitting the application for a license, the group has received support from scientists and clinicians all over the world.
"We are absolutely thrilled," she said. "The potential this area of research offers is immensely exciting and we are keen to take the work we have done so far to the next level."
Also, the group said it was launching a funding appeal to accelerate its research and is looking for private-sector partners.
Murdoch commented, "Realistically, we have at least five years of further laboratory-based work to do before we move to clinical trials, but this could be reduced if we receive additional funding, which would allow us to increase the size of our team."
The group is funded by the National Health Service, Newcastle University, the Department of Trade and Industry and the regional development agency One North West.
The license was granted by the Human Fertilization and Embryology Authority (HFEA), the government body that oversees in vitro fertilization and the UK's therapeutic cloning legislation. Suzi Leather, chair of the HFEA, said the authority agreed to the license after scrutinizing all the scientific, ethical, legal and medical aspects of the project, finding a "responsible use of technology."
Some view the license as an advance for British science, underpinning the UK's position in stem cell research. Apart from Sweden, other countries in Europe are opposed to cloning. Germany, in particular, has pursued a ban on both reproductive and therapeutic cloning at a European level and through the United Nations. Therapeutic cloning is excluded from the scope of European research funding.
In the U.S., therapeutic cloning has become an issue in the presidential election, with Democratic candidate John Kerry undertaking to reverse President George Bush's three-year ban on federal funding for the research, while Bush has pledged to maintain it.
The UK had a mixed response to the license, with researchers and patients' groups welcoming the move and anti-abortion groups opposing it. The ProLife political party said therapeutic cloning was "shoddy science," and it is considering whether a legal challenge to the HFEA decision is possible.
Julia Millington, director of ProLife, said, "It is perverse that in the current climate of concern for the protection of animals [involved in experimentation] the HFEA is allowing experimentation on human beings without even a murmur of public opposition."
The Newcastle Embryonic Stem Cell Group was established two years ago to explore the potential of stem cells in treating disease. In 2003, it became one of the first two UK groups to derive human embryonic stem cells from embryos produced for in vitro fertilization, but not implanted because they failed genetic screening tests.
That cell line, along with one produced at King's College London, has been deposited in the UK Stem Cell Bank that opened in May. By making embryonic stem cell lines available to approved research groups, the bank aims to reduce overall use of human embryos.