New legal agreement for UK depositors of EUTCD-grade hESC lines
now available for consultation
The UKSCB has developed a legal agreement
(an EUTCD Material Deposition and Distribution Agreement
(EUTCD-MDDA) ) to support the deposit, curation and distribution of
EUTCD-grade human embryonic stem cell lines.
The term EUTCD-grade has been adopted by
the Bank to describe those cell lines that have been procured,
derived, processed, tested and stored in compliance with the
EUTCD.
As a valued member of the UK stem cell
community, your views on it are being sought.
By way of background, the Bank was
established in response to Government recommendations to facilitate
the sharing and use of quality controlled hESC lines by the
research and clinical communities. One of the primary motivations
for this was to reduce use of embryos and make hESC lines available
without constraints. The Bank is overseen by an independent
Steering Committee, the Steering Committee for the UK Stem Cell
Bank and for the Use of Stem Cell Lines (the Steering Committee)
who approve all stem cell lines for deposit in the Bank.
Potential Depositors, will, as now, first
submit their applications to deposit EUTCD-grade hESC lines to the
Steering Committee. Subject to approval by the Steering Committee,
the Bank will contact the successful applicant and the new
EUTCD-MDDA will be executed prior to deposit of the cell line in
the Bank. The hESC lines will also undergo careful evaluation by
the Bank through a Due Diligence process, to ensure that the cell
line, in the opinion of the Bank, meets the requirements of the
UK’s Human Tissues (Quality and Safety for Human Application)
Regulations 2007 and HTA Directions.
The Bank is inviting members of the UK
community to participate in the consultation exercise on the
content of the proposed EUTCD-MDDA, which has been developed for UK
Depositors. Anyone is welcome to comment on the EUTCD-MDDA
agreement by January 27th 2012 to allow feedback to be
considered by the UKSCB.
If you are interested to contribute to the
consultation please contact enquiries@ukstemcellbank.org.uk.
The Bank would like to thank everyone in
advance for their interest, engagement and contribution towards
supporting the Bank in this new phase of advancing stem cell
therapies.