Many thanks for your letter of 2nd February regarding the current Government of proposals for regulation of research using chimera and hybrid embryos. I am pleased to provide the following information in answer to your three questions as follows:

  1.  "Is international access currently given to stem cell lines deposited in the UK Stem Cell Bank and, if not, is it expected that international access to such cell lines may be awarded in the future?"

  Response

  It was a requirement in the tender to establish the UK Stem Cell Bank that cell lines deposited in the Bank would be made available to users outside of the UK ie the UK Stem Cell Bank is an International resource. In fact the first approvals from the "Steering Committee for the UK Stem Cell Bank and for the Use of Stem Cell Lines" (hereafter "Steering Committee") for release of stem cell lines from the Bank includes provision of cells to laboratories outside of the UK. The Steering Committee has an explicit application process for assessing requests for the export of stem cell lines.

  2.  "What regulation is in place to oversee current or future national and international usage of stem cell lines released from the UK Stem Cell Bank?"

  Response

  The use of human embryonic stem cell lines in the UK is subject to authorisation by the "Steering Committee". The committee also approves any applications for stem cell lines to be deposited in the Bank and any requests to obtain such lines from the Bank. It is a critical criterion for the Steering Committee that for any projects in which lines are used in the UK, or projects outside the UK for which lines are released from the Bank, that the intended project should have been ethically approved and meet the general requirements of the regulation existing in the UK. It should be noted that the Steering Committee is not a statutory body and thus represents an essentially voluntary regulation with which the UK scientific community has complied. Whilst failure of researchers to comply with this regulation in the UK can be carefully reviewed, the Steering Committee regulation would be difficult to impose on non-complying recipients of UK Stem Cell Bank cell lines outside the UK. However, the risk of being "named and shamed" by the UK Steering Committee would probably be a significant incentive for most bona fide research labs to comply with requests from the Steering Committee.

  3.  "Does the deposit of stem cell lines derived from human-animal chimera or hybrid embryos eg through somatic nuclear transfer of human genetic material into enucleated animal ova present any specific issues of interest and/or concern to the UK Stem Cell Bank?"

  The decision to accept or refuse cell lines derived from human-animal chimera or hybrid embryos for deposit in the UK Stem Cell Bank would be delivered by the Steering Committee and not the Bank itself. If the Steering Committee were to decide that it was appropriate for the Bank to receive such cell lines this would as usual be carried out on a cell line by cell line basis and the Steering Committee would focus on the value of the lines to stem cell research and on the ethical governance associated with the lines. The concerns of the Bank would only apply to the technical difficulty and any safety issues associated with the culture of the lines. Following any decision by the Steering Committee that particular hybrid or chimeric cell lines should be deposited in the UK Stem Cell Bank the Bank staff would automatically begin the process of processing, banking and characterisation of the cells in readiness for their distribution when requests are submitted to the Steering Committee

  I hope this information is helpful. Please do not hesitate to contact me if you require further information or clarification.

February 2007