LONDON - Therapeutic human cloning must be allowed in the UK if the benefits of regenerative medicine are to be realized, Simon Best, CEO of Geron Bio-Med, the company that controls key patents around the cloning of Dolly the sheep, told a BioIndustry Association (BIA) meeting last week.

"The cloning of human cells for regenerative medicine opens up entirely new opportunities for the treatment of a wide variety of regenerative diseases," he said. "If further research is encouraged under appropriate regulatory and legislative oversight, regenerative cell therapies could become a clinical reality in the UK within the next decade."

These therapies would have substantial benefits in terms of extending health life span and reducing long-term care and medical costs, he said.

Unlike the U.S., where therapeutic cloning may be carried out in some states if the research is privately funded, the practice is banned in the UK. But there is concern that the UK may fail to take advantage of its lead in cloning research if the ban is not lifted. Earlier in April one of the UK's leading bioethics bodies, the Nuffield Council on Bioethics, recommended that the Human Fertility and Embryology Act of 1990 be amended to allow embryos to be cloned for the isolation and characterization of pluripotent stem cells. The act currently allows research on IVF embryos up to 14 days old in the areas of infertility, contraception, prenatal diagnosis and congenital diseases, but not for the derivation of stem cells.

Best argued that the law must be amended not only to allow the harvesting of stem cells, but also to allow the creation of clones. "This is important because nuclear transfer is currently the only available method of generating pluripotent stem cells from an individual patient that could be transplanted without rejection or the need for immunosuppression."

Geron Bio-Med, of Edinburgh, Scotland, is a subsidiary of Geron Corp., which last year succeeded in isolating human pluripotent stem cells. Geron Bio-Med was formed last year by the acquisition of the commercial arm of the Roslin Institute, the publicly funded research group that carried out the cloning work that led to the creation of Dolly.

Allowing cloning for the generation of stem cells will enable scientists to develop an understanding of how nuclear reprogramming works, said Best. "It is important to appreciate that the ultimate aim of this research is to carry out reprogramming without using human eggs."

Last June the government's main advisory bodies, the Human Fertilisation and Embryology Authority and the Human Genetics Advisory Commission, both recommended approval, but the government then set up another body, the Expert Advisory Group on Therapeutic Cloning. This body is due to report within the next few weeks.

The BIA supports the ban on reproductive cloning, but said the ban on producing human clones for research should be lifted. It argues that an extension of the law on embryo research would not transcend the ethical boundaries set by the act, saying, "Given the significant social consequences of degenerative disease in our aging population, it is important to allow such research to proceed."

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