SPECIAL REPORT
Development of a European Human Embryonic
Stem Cell Registry
The number of human embryonic stem cell (hESC) lines that are available and that are subsequently being
used in numerous research projects is increasing steadily. However, there is little coordination of hESC line
derivation, and comparative information on the characteristics and quality of these cells is sparse. Obtaining
consistent information on hESCs is hampered further by legislative fragmentation, particularly in Europe.
Recognizing these obstacles, the European Commission has set up a Human Embryonic Stem Cell Registry
(hESCreg) to make hESCs and their characterizing information accessible and to ensure that the results of
research become more quickly available to the public. The primary objectives of hESCreg are to provide
freely accessible information on existing hESC lines, their derivation, molecular characteristics, use and
quality. Successful research with listed hESC lines will be used to evaluate clinical potential and thus directly
influence policy decisions. The developing integration with other initiatives, such as characterization
projects, registries and cell banks, is expected to lead to a common and internationally accepted central
reference. The hESCreg provides a first step in this direction and might grow into an internationally funded
and administered project.
KEYWORDS: characterization, database, harmonization, human embryonic stem
cells, registry, website
Human embryonic stem cell (hESC) research
holds unprecedented promise for the development of cell therapies for degenerative pathologies and trauma. It may also provide new tools for
drug discovery and toxicity testing, as well as for
studying human development, disease physiology and gene control. The number of hESC lines
that are available and that are subsequently being
used in numerous research projects is increasing
steadily [1–3] . However, there is little coordination of hESC line derivation and comparative
information on the characteristics and quality of
these cells is sparse. This has severely hindered
reproducibility of findings and obscured transparency in the field. Obtaining consistent information on hESCs is hampered further by legislative fragmentation, particularly in Europe. This
reflects the continent’s historic pluralism and
the different ethical, philosophical and political
positions (FIGURE 1) . Recognizing these obstacles,
the European Commission has set up a Human
Embryonic Stem Cell Registry (hESCreg) to
make hESCs and their characterizing information accessible and to ensure that the results of
research become more quickly available to the
public. hESCreg has the mandate to improve
coordination and rationalization of hESC
research in Europe. The aim of using a comprehensive data source for measuring reproducibility
and enabling comparability and transparency in
the field has indeed received strong support from
the research community. A Steering Committee
(StC), a Scientific Advisory Board (SAB) and
an Ethics Advisory Board of leading hESC
researchers has been established to provide this
support to hESCreg (TABLE 1) .
The primary objectives of hESCreg are to
provide information on existing hESC lines,
their derivation, molecular characteristics,
use and quality. By doing so it will act as a
platform for coordination and cooperation.
A desirable outcome – accessibility of the
information to governmental bodies, regulators and the public at large – may be further
rationalization of the field. It will also help
to avoid redundancy and ensure comparable
quality standards.
10.2217/17460751.3.6.945 © 2008 Future Medicine Ltd
Regen. Med. (2008) 3(6), 945–951
Registry of hESC lines & projects
It is widely recognized that the complex and
multidisciplinary nature of hESC research
requires comparable information about the origin and availability of the cell lines, the methodology and standards for their derivation and
their functional and molecular characteristics.
Questions of reproducibility and standardization will be even more crucial when clinical or
pharmacological applications are to become a
reality. The registry aims to collect extensive
information on every available hESC line. The
major areas of hESC-related information are,
therefore, cell derivation and culture methods,
J Borstlap1†*,
A Kurtz2*, G Stacey3,
A Elstner2, A Damaschun1,
B Arán4, JC Gerlach5,
JC Izpisúa5 & A Veiga4,6
†
Author for correspondence
CellNet Ini a ve,
Berlin–Brandenburg Center for
Regenera ve Therapies (BCRT),
Charité – Universitätsmedizin
Campus Virchow-Klinikum,
BCRT, Augustenburger Platz 1,
D-13353 Berlin, Germany
Tel.: +49 304 5053 9400;
E-mail: joeri.borstlap@
charite.de
2
Cell Therapy Group,
Berlin–Brandenburg Center for
Regenera ve Therapies, Berlin,
Germany
3
The UK Stem Cell Bank,
South Mimms, UK
4
Center of Regenera ve
Medicine, Barcelona, Spain
5
Gene Expression Laboratory,
Salk Ins tute for Biological
Studies, La Jolla, CA, USA
6
Ins tut Universitari Dexeus,
Barcelona, Spain
*
Both authors contributed equally.
1
part of
ISSN 1746-0751
945
SPECIAL REPORT
Borstlap, Kurtz, Stacey et al.
A
hESC research and derivation (IVF), SCNT
hESC research and derivation (IVF)
hESC research on imported cell lines
No hESC-specific legislation in place
No hESC-specific legislation in place,
any kind of hESC research forbidden
B
Country
Number of hESC
lines derived
Belgium
17
Czech Republic
7
Denmark
26
Finland
10
France
1
Israel
15
Netherlands
4
Spain
10
Sweden
64
Switzerland
1
Turkey
11
UK
34
Total
200
Figure 1. Legislative status and number of human embryonic stem cell lines derived in Europe. (A) Legislative Status of hESC
derivation and research in EU27 and Switzerland, Norway, Turkey and Israel. (B) Number of hESC lines derived in countries that are
represented by members of the hESCreg Steering Committee and Scientific Advisory Board. The information on the number of derived
hESC lines were provided by the members of the hESCreg Steering Committee.
hESC: Human embryonic stem cell; SCNT: Somatic cell nuclear transfer.
including donation of embryos and consenting aspects. Data on stem cell lines will include
gene and protein expression, potency in vitro
and in vivo and, fi nally, hESC application in
research, medicine and industry.
Numerous protocols for derivation and expansion have been used so far, but information on
the comparative quality of cell lines generated by
different approaches remains inconsistent [4–7] .
ESCs have been derived with varying efficiency
from single cells, morula-stage embryos, as well
as from the inner cell masses of blastocysts, all
of diverse morphological qualities [8] , and variable success rates have been reported [2,6] . hESCs
were originally derived and cultured on mouse
feeder cells with bovine serum supplements, but
human feeder cells are now widely used and there
has been progress towards feeder-free and clinical-grade culture systems [9,10] . In addition, it is
foreseeable that hybrid and somatic cell nuclear
transfer (SCNT) hESC lines will be derived, with
946
Regen. Med. (2008) 3(6)
the additional need to develop standardized characterization methods and means for comparability. The registry will therefore provide information for every single cell line regarding the source,
stage, quality of the embryo, derivation procedure,
culture methods and media used, and the current status of available lines. Alternative pluripotent cells such as parthenogenetic stem cell lines
[11] , spermatogonial stem cells [12] and hESC-like
pluripotent cell lines from reprogrammed somatic
cells [13,14] are also under consideration for registration. Importantly, the hESCreg database will
also provide information on the provenance of the
cells, confirming that the embryos used to derive
cell lines were obtained with informed consent
from the donors.
Pluripotent hESCs are characterized by their
ability to differentiate into all cell types of the
endodermal, ectodermal and mesodermal lineages and the expression of a typical set of genes
and proteins. Several methods have been used to
future science group
Development of a European Human Embryonic Stem Cell Registry
demonstrate pluripotency of hESCs, including
in vivo teratoma as well as in vitro differentiation protocols. These characteristics appear to be
extremely important for the future clinical or
commercial use of these cells, since they allow
directed, defined and, therefore, controllable and
standardized manipulation. Standardization and
comparability are also critically dependent on the
data available regarding molecular markers for
hESCs and their differentiated progeny. The typical and sufficient expression profile for the characterization of hESCs still remains an intense area
of study. Recent research has compared hESC
lines at the gene-expression level to understand
molecular profiles of pluripotency and signatures
of typical hESC lines [15] . The identity of the pathways that are essential for the pluripotent state
is still not completely understood. Accordingly,
the activity of relevant pathways in specific hESC
lines will be registered in hESCreg.
Data analysis & mining tools
The molecular and biological data regarding each
cell line will be included in a data mining tool
using gene and cell ontologies. The complete
hESCreg dataset will be formatted for comparative analysis, data mining and scrutiny. The aim is
to enable researchers to use hESCreg as an instrument to independently derive and test hypotheses
and associations about the features and potencies
of the cells. Regulatory harmonization and standardization efforts may also be based on this information. Scientists can inform and choose from
available cell lines, submit new findings about
these cells and compare their own results with
other groups. An example of this mechanism is
the representation of the UK Stem Cell Bank in
the hESC registry. The information generated
by the bank on the cell lines it stores is treated as
a data ‘supplement’ to the originally registered
cell line information. Thus, independent and
repetitive confirmation of cell-specific data will
be visible to the user through active participation
of scientists. This external validation process is
aimed at transparently assessing the quality of a
specific line in relation to other lines.
The registry has implemented criteria for the
registration of hESC lines. These basic criteria
(‘registration information’) include information on the provider/owner and availability, cell
derivation and culture methods, and gene- and
protein-expression features that are necessary
for the basic assessment of a hESC line (TABLE 2) .
Registration of a hESC line requires submission of information to show that the cell is a
pluripotent hESC. It includes embryo data
future science group
SPECIAL REPORT
Table 1. Members of the Scientific Advisory Board, Steering
Committee and Ethics Advisory Board of hESCreg.
Name
Institution
Country
Andersen, Claus Yding
University Hospital Copenhagen
Denmark
de Guerra, Arnaud
Agence de la Biomedicine
France
Dvorák, Petr
Masayrk University Brno
Czech Republic
Hovatta, Outi
Karolinska Institutet
Sweden
Jaconi, Marisa
University of Geneva
Switzerland
Kurtz, Andreas
Charité Universitätsmedizin Berlin
Germany
Mummery, Christine
Netherlands Institute for
Developmental Biology
Netherlands
Reubinoff, Benjamin
Hadassah University Hospital
Isreal
Sermon, Karen
Vrije Universiteit Brussel
Belgium
Stacey, Glyn
NIBSC, UK Stem Cell Bank
UK
Tuuri, Timo
University of Helsinki
Finland
González, Victor
Instituto de Salud Carlos III
Spain
Steering committee
Scientific advisory board
Andrews, Peter
University of Sheffield
UK
Braude, Peter
King’s College London
UK
de Sousa, Paul
Roslin Cells Ltd.
UK
Dinnyes, Andras
Szent Istvan University
Hungary
Findikli, Necati
International Hospital Istanbul
Turkey
Ganten, Detlev
Charité Universitätsmedizin Berlin
Germany
Gerlach, Jörg
University of Pittsburgh
USA
Henriche, Domingos
Faculty of Medicine of Lisbon
Portugal
Hyllner, Johan
Cellartis AB
Sweden
Izpisúa, Juan Carlos
Salk Institute for Biological Studies
USA
Lako, Majlinda
International Centre for Life –
Newcastle University
UK
McKay, Ronald
NINDS Porter Neuroscience Research USA
Center
Menéndez, Pablo
Andalucía Stem Cell Bank
Spain
Michalska, Anna
Monash Medical Centre Stem Cell
Laboratory
Australia
Peschanski, Marc
INSERM U421/IM3
France
Robertson, Marylin
Scottish Stem Cell Network (SSCN)
UK
Savatier, Pierre
INSERM U846
France
Simón, Carlos
Centro de Investigacion Príncipe Felipe Spain
Sunde, Arne
University Hospital of Trondheim
van Steirteghem, Andre European Society Human
Reproduction & Embryology
Norway
Belgium
Ethics advisory board
Casado, Maria
Universitat de Barcelona
Spain
Englert, Yvon
Université Libre de Bruxelles
Belgium
Tanner, Klaus
Ruprechts-Karl University, Heidelberg Germany
Steering Committee members provide information regarding the human embryonic stem cell research
in each country. Scientists of the Scientific Advisory Board represent the scientific core of the registry
and have a determinant role in ensuring that adequate scientific criteria have been implemented and
adhered to during the preparation and management of the registry.
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947
SPECIAL REPORT
Borstlap, Kurtz, Stacey et al.
Table 2. Registration Information.
Registration
information
Categories
General
Information on the original cell line name and if the cell line is a subset of an already existing cell line. The
provider also indicates if informed donor’s consent exists and if the donor is traceable. The cell line will be given
a systematic registry name for traceablility within the registry.
Information on whether the origin of the cell line is an embryo or an induced pluripotent stem cell.
Information on the derivation method of the embryo (in vitro fertilization, somatic cell nuclear transfer,
parthenogenesis). Information on the embryo stage for single-cell preparation.
Information on whether the cell line is available or not.
Information on the karyotype of the cell line, on the passage number at which the karyotype was determined
and on any change of karyotype.
Information on the genetic modification of the hESC cells whether it was inherited (genetic disorders) or
induced (knockout, transgene).
In vitro: Information on the method of in vitro differentiation into cells of all germ layers (e.g., spontaneous
differentiation, embryoid bodies or directed differentiation).
In vivo: Information on the method of in vivo differentiation (teratomas or chimeras indicating whether one, two
or three germ layers were formed).
hESC markers proposed as hESCreg standard:
ALPL/CD9/DNMT3B/GABRB3/GCTM2/GCT343/ GDF3/NANOG/POU5F1 (OCT-4)/SSEA-3/SSEA-4/ TRA1–60/
TRA1–81/TDGF1/THY1 (CD90)
Other hESC markers: REX-1/ SSEA-1/SOX-2
Derivation data
Availability
Karyotyping
Genetic modification
Differentiation
Cell markers
Information on characteristics that are necessary for the basic assessment of a hESC line in Human Embryonic Stem Cell Registry. Registration and addititional
information, as well as specific contents are dynamic and will therefore be adjusted as hESC research and the project develop.
hESC: Human embryonic stem cell.
regarding the use of fresh or frozen embryos and
if they have been obtained by in vitro fertilization, SCNT, parthenogenesis or other means.
Karyotype data are requested and both in vitro
and in vivo differentiation potency and markers
of pluripotency have to be reported. A second
level of information (‘additional information’)
includes data from the screening of embryo
donors, embryo quality information and derivation methodology details. Special attention
is given to culture conditions, regulatory documents and publications. It is planned to extend
this level of information with additional geneand protein-expression profi les and biological
data, as well as with information on preclinical and clinical applications. Both ‘registration
information’ and ‘additional information’ are
regularly reviewed and updated.
The database provides a public online ‘front
end’, or homepage (FIGURE 2) , with listings of lines
according to defined criteria and quality standards, search features and general background
information, for example, regarding politics, ethics and news. A secure ‘back end’ can be reached
after accepted registration. Here, providers can
register cell lines and researchers can register
research projects or enter publications.
A data evaluation bar system indicates how
much data are available on each registered hESC
line [16] . With regards to hESC-specific characterization, a hESC line in hESCreg receives
one bar if at least four markers proposed within
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Regen. Med. (2008) 3(6)
the registration information of hESCreg have
been evaluated by the provider together with
the proof of differentiation into all three germ
layers. The cell line receives another bar if the
expression of a core set of markers (including
NANOG, TDGF, POU5F1, GABRB3, GDF3
and DNMT3B) as proposed by the International
Stem Cell Initiative [15] has been evaluated by
the provider.
Integration between the hESCreg and other
registries may initially be facilitated by providing links to the respective sites. In the long term,
however, a globally shared database should be
established. Implementation of the logistic effort
for this kind of global registry is presently in
preparation.
Quality assessment
The quality of the data available from hESCreg
is critical to its international scientific impact
and its ethical acceptability within Europe.
The registry first established criteria for ‘quality’ and, most importantly, what that means
to the intended users. In addition, it is also
responsive to how it will be perceived by the
public and pressure groups who will wish to see
a demonstration of correct handling of ethical
issues. Strict evaluation of data provided for the
project in an open, fair and scientifically rigorous
process is essential. Sustaining a neutral position on the science and ethics is also essential,
and the input of various advisors consulted in
future science group
Development of a European Human Embryonic Stem Cell Registry
the development of the registry will be handled
carefully. This will be vital to ensure that the
natural debates that must be allowed in science
and ethics are enabled whilst ethical matters are
dealt with appropriately from a European perspective, acknowledging national differences,
without compromising the value of the data
accommodated on the database.
There is strong focus on seeking quantifiable
data that can be standardized for the different
lines to enable direct comparison of data and
SPECIAL REPORT
information on the registry. Existing standards
will be employed wherever possible and a consensus will be sought from the StC and SAB and
other qualified sources where no standards exist.
Protocols are established to deal with differences
of opinion and other conflicts so that relevant
discussions and alternate positions are dealt with
in an open and fair way.
In order to deliver various aspirations the key
features of this project include a code of practice and detailed protocols for its operation and
Figure 2. Screenshot of the Human Embryonic Stem Cell Registry database homepage. The online access to information on hESC
lines, research projects and publications is free. General background information, for example ethical issues, hESC research and funding,
is available on the public front end.
hESC: Human embryonic stem cell; hESCreg: Human Embryonic Stem Cell Registry.
Taken from [106] .
future science group
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949
SPECIAL REPORT
Borstlap, Kurtz, Stacey et al.
careful evaluation of risks for the quality of the
registry for all stakeholder groups. In this way,
it is intended that the registry will command
the highest level of respect on an international
level and could provide a model for resolution of
international data on stem cells in a way that is
scientifically robust and accommodates cultural
diversity. Last, hESC lines generated in Europe
will, for the first time, be listed and be accessible
from a central database.
International harmonization
Since the field of hESC research is still in its infancy
and expected to develop, the consortium is explicit
in its openness to incorporate additional partners
and to closely collaborate with European and international initiatives in the field. Cooperation and
networking with European and global initiatives
is facilitated through the SAB, workshops and
scientific meetings. Furthermore, the European
Commission has requested that the 18 ongoing
projects that use hESC within the 6th Framework
Programme for Research and Technological
Development [101] should register these lines with
hESCreg. Since there are a several non-European
hESC lines under research in these projects, this
documentation extends beyond Europe.
In general, hESCreg aims to facilitate co-operations through modular extensions of the database.
These extensions meet the specific requirements to
cover the information from the respective projects
and initiatives. These modules may be outsourced
to external websites in which they can function as
autonomous platforms that synchronize with the
registry through defined interfaces. Within the
hESCreg website, modules function as add-ons
and modes of operation that may be switched on
or off. Currently, this concept is being developed
with the International Stem Cell Initiative (ISCI)
and the International Cell Banking Initiative of
the International Stem Cell Forum (ISCF) [102] ,
the UK Stem Cell Bank [103] , the International
Society for Stem Cell Research (ISSCR), which
plans to develop an international registry about the
ethics and political conditions of hESC research
[104] , as well as with the Ethics Initiative from
the ISCF, which is coordinated by the Canadian
Stem Cell Network. The registry aims to establish
similar cooperations with further international
developments such as:
The Interstate Alliance on Stem Cell Research
(IASCR), which also includes the California
Institute for Regenerative Medicine (CIRM),
and in which the US National Academies of
Science play a central role [105];
950
Regen. Med. (2008) 3(6)
The National hESC Bank in Wisconsin,
USA, which is providing the cell lines that are
available for use in projects of the NIH [102] ;
The Stem Cell Network of the Asia–Pacific
region (SNAP), including relations to China,
the Academies of Science in Taiwan, the
Center for Developmental Biology in Japan
and the Australian Stem Cell Center [17] ;
The International Consortium of Stem Cell
Networks (ICSCN), a consortium of 14
national stem cell networks and an ideal forum
to disseminate information about the project
and to initiate international collaborations. The
ICSCN has compiled a table of global regulations, policies and organizations regarding
hESC research for its members [106] .
Future perspective
We expect the registry to promote knowledge
exchange on the availability of hESC lines, but
also to enhance transparency in the field on a scientific as well as on the socio–ethical, legal and
policy levels. Successful research with listed hESC
lines will be used to evaluate clinical potential, and
thus directly influence policy decisions. It will also
identify centers for certain cell applications that
can improve training and exchange for European
scientists. The developing integration with other
initiatives such as characterization projects, registries and cell banks is expected to lead to a common and internationally accepted central reference. The hESCreg provides a first step in this
direction and might grow into an internationally
funded and administered project.
Acknowledgements
We would like to thank the members of the Steering
Committee, Scientific Advisory and Ethics Advisory Board
of hESCreg for their help in obtaining information on hESC
lines derived and on the status of hESC legislation in their
countries. We thank M Walthert (Berlin, Germany) and
K Schenk for database design and Q Vinh Phan for support
in graphical design.
Financial & competing interests disclosure
hESCreg is supported by a grant from the European
Commission as a Specific Support Action within the 6th
Framework Programme for Research and Technological
Development, contract number 037820. The authors have
no other relevant affiliations or financial involvement with
any organization or entity with a financial interest in or
financial confl ict with the subject matter or materials
discussed in the manuscript apart from those disclosed.
No writing assistance was utilized in the production of
this manuscript.
future science group
Development of a European Human Embryonic Stem Cell Registry
SPECIAL REPORT
Executive summary
Need for a registry
The promise of new life-saving therapies through human embryonic stem cell (hESC) research is challenged by ethical issues that create
a dilemma for some.
This issue establishes the need for careful control of this work.
A registry would provide a central reference for acceptability of use of hESCs in the EU.
The Human Embryonic Stem Cell Registry (hESCreg) coordinates scientific, technical and ethical issues.
Data
hESCreg has established criteria for a registry.
A front-end public area is presented with a certain data set.
A back-end secure area enables access after registration and permits downloading project and banking data.
A ‘bar’ system evaluates spread and depth of data available on each line.
Links to other databases are anticipated and have been built into the planning.
Quality
Quality can be viewed from many perspectives, but it is vital that the perspective of database users are foremost.
The public are primarily concerned with appropriate handling of ethical governance and promotion of therapeutic progress.
Stringent evaluation of data is vital, and this is delivered by seeking expert advice and dealing with ethical and scientific debate in a way
that captures the debate where there is no clear resolution.
The hESCreg project seeks to quantify data and utilize existing standards or develop these through the Steering Committee and
Scientific Advisory Board input.
A Code of Practice will be established to demonstrate accountability for operation of hESCreg.
International harmonization
All FP6 projects are requested to input to hESCreg by the European Commission.
Modular design enables effective links with other databases, for example, the International Stem Cell Initiative.
Plans are established to coordinate with other developing databases: International Society for Stem Cell Research, the Interstate Alliance
on Stem Cell Research, International Stem Cell Forum and Banks.
8
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