Issues in stem cell research and clinical translation

7 January 2009

Therapeutics derived from stem cells are considered to hold significant promise as potential interventions against a range of serious forms of injury and disease; however, as yet there are few clinically proven stem-cell treatments. The International Society for Stem Cell Research (ISSCR) released new guidance late last year aimed to ensure that appropriate consideration of relevant scientific, clinical, regulatory, ethical and societal issues is maintained in clinical development and translation. The new document, Guidelines for the Clinical Translation of Stem Cells, looks at steps that need to be completed in order to move from current areas of research to effective therapeutics, and call for rigor and transparency with respect to scientific findings, oversight and consent to participate in clinical trials. The ISSCR specifically criticises clinics that presently “exploit patients’ hopes by offering unproven stem cell therapies, typically for large sums of money and without credible scientific rationale, oversight or patient protections” (see press release) and propose that the new guidance will equip patients and their doctors with the information they need to make informed decisions about whether or not to consider participation in stem cell research trials. An investigation of websites that already offer stem cell therapies for serious diseases has found that most make unproven claims of therapeutic benefits, in countries where provision of such treatments is not strictly regulated such as China and Russia (see Times article); the ISSCR has urged all countries to develop appropriate regulatory systems.

The Roman Catholic Church has released a position statement on human stem cell research; the document Dignitas Personae opposes the use of stem cells derived from aborted human fetuses or embryos created by cloning, but finds the use of stem cells derived from adults, umbilical cords or human fetuses that died naturally acceptable (see press release).

In a significant ruling, the Enlarged Board of Appeal (EBoA) of the European Patent Office (EPO) has ruled against an application from the Wisconsin Alumni Research Foundation for a method of deriving stem cells from human embryos; although the US Patent and Trademark Office granted the patent, the EPO has finally rejected it on the basis that commercial exploitation of the patent would be "contrary to public order or morality" and hence not permissible according to their own convention (see Nature news article). The EBoA stressed that this decision does not concern the general question of human stem cell patentability” (see press release), and many companies are likely to get round this issue by filing patents for individual countries rather than European-wide patents (see Guardian news article). Had the patent had been upheld, however, it would potentially have covered virtually any application relating to the use of human embryonic stem cells, so that any companies or hospitals using such applications  in Europe could have been compelled to pay licensing fees.

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