Regulation and research in stem cell medicine

3 July 2008

Regenerative medicine has continued to feature in the headlines recently. The European Science Foundation has announced plans to strengthen the research base in this area, which they define as the development of stem cell therapies to restore lost, damaged, or ageing cells and tissues in the human body” (see press release). The new REMEDIC initiative, a five-year a research networking programme intended to facilitate information exchange and collaborative research, is supported by organisations from several European countries including Germany, Spain, Switzerland, Austria and the Netherlands. The Canadian government has announced funding of more than $100 million for the Canadian Cancer Stem Cell Consortium (see CBC news), which is to join with the California Institute for Regenerative Medicine (CRIM) in the US for a project on the role of cancer stem cells in disease development (see press release). CRIM has also announced a collaborative partnership with the Australian state of Victoria (see press release).

 

Stem cell researchers in California have called for a relaxation in state legislation to permit financial compensation for women who donate eggs for the creation of human embryonic stem (HES) cell lines (see Nature news). In some US states, it is legal for women to receive payment for donating eggs (ooctyes) for fertility treatments, but not for research purposes, making it difficult for researchers to recruit donors and, they say, stifling the progress of research. In the UK, women may donate eggs for fertility treatment or research in exchange for limited financial compensation (see previous news), or in exchange for a reduction in the price of their own fertility treatment (see previous news).

Meanwhile, a new publication in the journal Cell Stem Cell has claimed that countries with less restrictive regulatory regimes account for a disproportionately high level of scientific publications [Levine AD (2008) Cell Stem Cell2(6): 521-4], supporting concerns cited by many prominent US researchers that without easing of current legislation such as current restrictions on the use of federal funding for stem cell research (see previous news), the country will lag behind in this area of medicine. Countries dubbed ‘overperforming’ in stem cell publications were Singapore, the UK, Israel, China and Australia, whilst ‘underperformers’ included the US, Japan, France and Switzerland (see Nature news). The author concludes that the most highly performing countries had generally permissive policy environments for HES cell research, whilst those lagging behind were characterised by “protracted policy debates and ongoing uncertainty, regardless of their current policy environment”.

Within the UK, there is debate about the regulatory remit of relevant statutory authorities, with the HTA, HFEA and MHRA issuing a position statement on the use of human embryonic stem cells for human application. The potential for more general debate is evidenced by the discussion and media exposure surrounding the passage of the Human Fertilisation and Embryology Bill through Parliament (see previous news), but surveys of public attitudes have suggested that up to 79% of respondents were broadly in favour of the use of human embryos for medical research (see Times article).

Whether the public have a reasonable expectation of how long it might take for major benefits from such research to be realised is less clear, since progress is always publicised. For example, a triumph cancer ‘cure’ from therapeutic cloning has been hailed (see BBC news) following the publication of a paper in the New England Journal of Medicine detailing remission of a malignant melanoma (skin cancer) for a two-year period. Using immune cells produced by the patient’s body, US researchers created CD4 T-lymphocytes directed against a tumour-specific protein, cloned them and produced a massively expanded population of identical cells, which were then reintroduced to the patient [Hunder NN et al. (2008) N Engl J Med. 358(25):2698-703]. Although not all of the tumour cells were producing the corresponding protein, the patient’s immune system was apparently able to respond effectively against all the tumour cells.

This study is published in a respected peer-reviewed journal and does not make misleading claims, but concerns have arisen from the growing phenomenon of unproved ‘stem cell treatments’ being offered via private clinics and commercial websites. The International Society for Stem Cell Research is reportedly developing guidelines to condemn the use of stem cell treatments outside clinical studies (within which stem cell use is subject to regulation including research ethics approval)..These guidelines are intended to protect the safety of patients and combat misleading claims made about stem cell therapies (see Reuters news).

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