Submission from National Institute for
Biological Standards & Control
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
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?"
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?"
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