The European Commission recently launched the European Human Embryonic Stem Cell Registry, a database that is expected to help standardize and harmonize disparate stem-cell research projects, methodologies, and regulatory frameworks of the 15 nations participating in it.
“The registry should promote the validation and efficient use of the knowledge related to these cells for research,” Andreas Kurtz, a researcher at the Berlin-Brandenburg Center for Regenerative Therapies and a lead partner in the registry, told CBA News in an e-mail this week. “It provides, for the first time, a verifiable overview of the existing cells, and allows comparability and, most importantly, a means to establish standards for the cells.”
Among the data the registry will contain is information on the embryo from which the cells were harvested, including genetic information, status of the embryo, source of the embryo, and date of derivation; the methods used to harvest, expand, and cultivate the cells; the phenotypic properties of the cell lines, including gene- and protein-expression data, expression of markers, and karyotype; and the functional properties of the cells, including the potential to differentiate in vitro and in vivo.
“The registry attempts to follow changes in cell lines during cultivation or genetic and other modifications by defining subsets,” Kurtz said. “It will also be posted in which research projects the cell line is being used or has been used, and what results were obtained.”
Results from the use of a cell line in preclinical animal testing and clinical work, the types of differentiated cells derived from the cell line, the regulatory framework for cell harvesting, and the regulatory background for hESC research in the different countries from which cells are registered will also be reflected in the registry, Kurtz said.
He said the registry could be useful in drug-discovery efforts because it includes data on how hESCs or their derivatives respond to drugs, and data on gene and protein expression, pathways, potency, cell subsets, and subclones. This information is searchable and may enable researchers to compare and select cell lines for specific projects.
The registry, which is open to all, has “already received enormous feedback” from the general public, investors, clinicians, researchers, and drug makers, said Kurtz. “The response from the research community and the enthusiasm to participate in reaching the goals of the registry supports its necessity.”
Future tasks include developing tools to search, mine, and compile the data collected in the registry to help researchers compare and standardize linkage to cell, gene, and expression databases and ontologies, Kurtz said.
“The response from the research community and the enthusiasm to participate in reaching the goals of the registry supports its necessity.”
He added that is the registry, available here, might also include other pluripotent cells, including induced pluripotent stem cells, or iPS cells.
Identifying a Need
The registry made its debut at the inaugural State of the Art in hESC Research, European hESC Policy, and International Harmonization symposium, held in Berlin last month.
The EC in early 2007 began funding the registry with just over €1 million ($1.5 million) over three years under the 6th Framework Program for Research and Technological Development, Kurtz said. Funding is scheduled to end in 2010.
Other partners in the project include Berlin Center for Regenerative Therapies researchers Kurtz and Joeri Borstlap; Anna Veiga, stem cell bank director of the Barcelona Stem Cell Bank at the Center of Regenerative Medicine; and Glyn Stacey, director of the UK Stem Cell Bank.
The partners are supported by a 12-member steering committee of hESC researchers from each of the ten EU countries in which this research is allowed —Belgium, the Czech Republic, Denmark, Finland, France, Germany, Spain, Sweden, the Netherlands, and the UK. (Israel, Turkey, the US, Australia, and Switzerland are also participating in the registry.)
New partners will be adopted when additional countries join the hESC research community, said Kurtz, who added that an “independent” international scientific advisory board of hESC researchers and an ethics advisory board provide ”relevant guidance.”
According to Kurtz, the registry came into focus in 2000 after the EC’s European Group on Ethics, an advisory body, identified the need for more transparency and public control of research with human embryonic stem cells, and “insisted that the results of such research should be widely distributed and not hidden for commercial reasons.”
He said that the advisory group made its recommendation after it noticed a fragmented or non-existent legal environment for hESC research in Europe, a lack of information on the numbers of hESC lines, and differing guidelines under which they were generated.
Armed with these recommendations, the EC in 2004 issued a call for proposals to establish a human embryonic stem cell registry. The goal was to “contribute to an optimal access to and use of stem cells, ensuring that the results of research ultimately become more quickly available to all patients across Europe,” according to Kurtz.
According to Tim Allsopp, CSO of UK-based Stem Cell Sciences, the registry “looks to be an interesting initiative.”
Kurtz said that the registry partners hope that the EC will continue to fund the project after it expires in 2010. “The European Commission has said that if the [registry] proves useful, then we can issue another call for further funding,” said Anna Veiga, director of the Barcelona Stem Cell Bank and a leading partner of the registry.
Added Allsopp: “With most of these types of initiatives, such as cell banks or registries of information on banked cell lines, one must try to seek continuity of funding to support the ongoing evolution of the project, otherwise it just is not as significant if it was to simply expire after a three-year duration.“