Wellcome waits on starting block

October 26, 2001

A national cell bank could allow the UK to take the lead in stem-cell research, says the Wellcome Trust's Robert Terry

The recent change in the law regulating the purposes for which human embryos can be used in research has been seen by many as a step that should position the United Kingdom at the forefront of stem-cell research. The Wellcome Trust has supported a change in the regulations. We believe stem cells, particularly those that could be derived from early-stage human embryos, offer enormous potential for the development of revolutionary treatments for serious injuries and debilitating diseases. These points were reiterated last week when the trust presented evidence to the House of Lords inquiry on stem-cell research. Our evidence also highlighted a number of issues that remain unresolved.

People have asked when the first therapies will appear. No researcher likes to be pinned down on this question. But it is now possible to start work on much of the basic human biology previously denied to researchers. This work can build on the body of knowledge gained from animal stem-cell models, particularly from mice. We should not forget that human adult stem cells have been transplanted regularly as part of bone marrow or cultured for skin grafts for a number of years.

The first applications might be seen in the repair of physical injuries such as nerves in spinal breaks or cardiac tissue following a heart attack. Whatever treatments are developed will be quite different from standard drug therapies. Extensive patient trials will be needed to ensure among other things that stem-cell grafts are stable in the patient, are not rejected and remain in place. Cells for clinical use must be well characterised, stable and free from viruses and other potential disease-causing agents.

This raises the issue of whether the existing regulation of stem-cell research and its application is adequate to cope with these new developments. The Human Fertilisation and Embryology Authority has been an effective regulator of fertility research. The trust considers that it should be just as effective in licensing the new research purposes.

One area of concern with respect to embryonic stem cells is that, once derived, the stem-cell lines are no longer covered by the remit of the HFEA. There is no legislation in force to regulate the distribution of, or research using, stem cells that have been derived from embryos. Nor is there any such legislation covering the use of foetal or adult stem cells. The trust is concerned that best practice guidelines for the storage and distribution of all stem-cell types be introduced in the UK. The guidelines should also address issues such as donor confidentiality and consent. Developing such guidelines does not fall within the responsibilities of the HFEA.

One part of the solution might be the creation of a national cell bank facility as suggested by the chief medical officer, Liam Donaldson. This could provide a reliable storage facility for derived cell lines and produce guidelines for good practice. While accepting the need to support basic research, the priorities of clinical use should be brought to bear when deciding how cell lines are derived and stored. Cell lines should be derived in a regulated laboratory environment to ensure that they can be used clinically should an application be discovered. It will be important to involve experts on regulatory standards from the outset and to adopt appropriate guidelines such as the Code of Practice for Tissue Banks published in March by the Department of Health.

The existence of a national cell facility will, we hope, mean that standardised research material can be made available to the research community. The exact terms and conditions under which such a facility might operate are yet to be determined.

The issue of intellectual property will need to be addressed. Human cell lines have been patented for a number of years, and patent protection would probably be required for any therapy to be developed commercially. The difficulty, as with many aspects of biotechnology, is where to apply a patent in the continuum from discovery to invention. There is much interest in whether the European Patent Office will accept the application from the Wisconsin Alumni Research Foundation for a patent on the method of stem-cell derivation. The granting of a patent in the United States has led to a virtual monopoly on the derivation of stem-cell lines there.

We await the findings of the House of Lords inquiry with interest.

Robert Terry is senior policy officer at the Wellcome Trust.

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