A European Human Embryonic Stem Cell (EU hESC) Registry, as part of the Sixth Framework Programme of the European Commission will be in place shortly. Work on the registry is to begin in October / November 2006 with the website and database going live in the second half of 2007.
Human embryonic stem cell (hESC) research holds promise for the development of therapies for degenerative pathologies, offers a tool for drug discovery and toxicity tests, for studying human development, disease physiology and gene control. The hESC lines are currently derived in an increasing number of laboratories in Europe and around the world.
A detailed registry of available cell lines will promote the validation and efficient use of these precious cells for research and application. Comparable information is needed about the origin of the cell lines, the methodology and standards for their derivation and the characteristics to assess their availability for research and future therapies. The growing use of hESC by the scientific community demands a high quality and comprehensive registry.
The aim of the proposed European hESC registry is to promote access to all hESC lines derived in Europe and transparency about their characteristics. Only well defined and adequately characterised hESC lines according to the parameters established by the registry be listed. To determine listing decisions, the features of the cell lines will be evaluated according to defined scientific and quality standards.
Data such as the origin, the derivation methodology, as well as the different parameters used for characterisation will be recorded for each hESC line in the registry. Contact data and legal status will also be available for each cell line. Each cell line will be annotated with essential and useful information on their characteristics and applications.
The registry will contribute to the harmonization of the use of the reported cell lines, spreading of standards and good practice in cooperation with other international registries. It will contribute to the responsible limitation of the number of embryos needed for derivation of new cell lines by promoting access to existing hESC lines, exchange of information about these cells and transparency towards the European legislative landscape.
Registry of the database and website will facilitate the continuous mapping of the research and legislative landscapes in a topographical online design. The registry will also serve as a communication and consultation platform for hESC researchers, clinical groups, patients groups and the public at large for information on hESC.
A Steering Committee (StC) of national representatives with inventory and administrative tasks will be formed. One representative from each country where hESC research is performed will serve as national contact person. Updated information about the situation in each country and the cell lines that are available will be provided by the StC.
A Scientific Advisory Board (SAB) is constituted of leading European scientists in the field of hESC research. The SAB will advise and assure the scientific and technical quality of the registry and serve as control body of the registry. The operational management will be coordinated by a Berlin-based information technology team (Charite-Universitatsmedizin Berlin) and a Barcelona-based operational team (Centre de Medicina Regenerativa de Barcelona), which will determine and control hESC-eligibility criteria and coordinate work with the StC and the SAB.
The selection of partners will guarantee the short-term establishment of an independently managed European registry of outstanding quality, close interaction with relevant European and global initiatives and international acceptance.