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Report

Teaser, summary, work performed and final results

Periodic Reporting for period 1 - hPSCreg (Human Puripotent Stem Cell Registry)

Teaser

Summary

Human pluripotent stem cells (hPSC) can differentiate in all cell types of the human body and can be expanded without limit. The cells are genetic surrogates of their donors. These three characteristics (potency, expandability, personalization) make these cell enormously valuable for cell therapy and regenerative medicine, for disease and tissue modeling and for testing of drugs, toxins and chemicals. While human embryonic stem cell (hESC) lines are derived from early human embryos, induced pluripotent stem cells can be generated from any somatic cell. Both cell types are currently being used in research, including in clinical trials. To have knowledge about available hPSC â€“ lines, their quality, their ethical provenance and availability, a central registry is required to provide this information.

The human pluripotent stem cell registry fulfills this task. It the most accepted and complete hPSC-registry providing transparency in the field, an invaluable resource of cell lines and their application and developing and promoting standards and guidelines. In addition, the Registry reduces risks in the field by enabling comparability and reproducibility, as well as avoiding waste of resources by providing access to hPSC-lines worldwide. The Registry is also instrumental in promoting quality standards of lines. Substandard lines will not be accepted for use by the community, while lines in hPSCreg fulfill a validated standard. Hence, the hPSCreg is a global hub for hPSC data and information.
The objectives of the project are driven by the needs for a comprehensive public information source for pluripotent stem cells, as outlined in the call: to gather and make available detailed information on the different hPSC lines derived in Europe and beyond, thereby also avoiding needless creation of new cell lines. This registry operates through an internet website that will continue to provide high quality data about the lines (e.g. cell characteristics), details regarding their source and contact information regarding their location.

The objectives are divided into the main concept areas (i) acquisition, registration and qualification of information, (ii) communication, dissemination and harmonization, (iii) technical implementation, governance and project management. The specific objectives are (1) Provision of validated ethics information for each cell line, (2) Provision of validated scientific information for each cell line, (3) Provision of information on clinical application of hPSC lines, (4) Establish and strengthen international reach and community interaction as well as acceptance, (5) A stable state of the art back- and frontend must be established and maintained and (6) Implement a synergistic management structure supported by clear governance tasks.

Work performed

The work performed can be framed in two major areas. First, maintaining technical and scientifiic functionality and second, development of Registry content, accessability and expanding itâ€˜s functionalities. The following tasks were performed:

1. Further development of the unique ethics data model. This model was implemented in hPSCreg. A final version for data output and searchability is being developed with community input.
2. Cell line registration is a continuous task to increase the number of lines, and their data quality, in hPSCreg. The registration data model was improved and implemented. The number of registered hESC-Lines increased from 717 (2007-2016) to 797 by 06/2018 and of hiPSC-lines in this period from 788 to 2664. The number of registered projects using hPSC lines increased also from 81 to 110.
3. Clinical use of hPSC will be the next revolution in cell therapy. Therefore, hPSCreg entered into collaboration with the Global Alliance for iPSC Therapy (GAiT) to develop a data model for clinocal grade hPSC lines. This model is currently under review by GAiT members and by the International Stem Cell Baninking Initiative (ISCBI). Furthermore, hPSCreg has developed a data model fort he regoistration of stem cell based clinical trials, in collaboration with the Robert-Koch-Institute in Germany and with the CRMB in Barcelona.
4. The Registry has expanded ist global outreach by entering into collaboration with EBiSC, ISCBI, GAiT and several other banks and initiatives in the USA and Japan.
5. We set up social media tools and a feedback and commentary option in hPSCreg. We have authored and co-authored several publications.
6. The Registry team provided and maintained an accurate, safe and carefully constructed database (backend) and portal (front end) as a continous task, which fully complies with GDPR. An adequate management structure and relevant documentation oft he code and of all Registry related administrative tasks was implemented.

Final results

The Registry is a globally leading resource for hPSC-line data and serves as a central hub to access hPSC-lines from diverse resources worldwide. Scientists have a single portal to assess a very broad range of hPSC â€“ lines to compare data directly and rapidly select hPSCs of greatest suitability for their research and assure it meets accepted norms in an ethically complex area. Importantly the portal avoids wasting time and effort trying to access and then culture unsuitable or unqualified or unscreened cells, or generate new cell lines. A unique hPSCreg reference, based on a standard name developed by hPSCreg, for the first time allows tracing of cell lines through resources, publications and registers, avoiding recognized problems of confusion and irreproducibility of research due to different cells with similar names or closely related clones.
hPSCreg provides companies with a tool to help reduce risk to commercial development by cell selection through availability of qualified ethics and scientific data. The hPSCreg data model also serves as basis for EBiSC, StemBancc and other resources and the lines are accessible through hPScreg.
The Registry provides direct access to ethics provenance information. This is unique and allows assessment of suitability from an ethical point of view. In addition, hPSCreg issues certificates, which verify that a line adheres ethically and scientifically to the highest standards, based on the submitted data. These certificates are required for funding for example by the EC. hPSCreg also serves as a reviewer for publication in the journal Stem Cell Research â€“ Lab Resource by validating submitted data on hPSC â€“ lines.
Stem cell technology has significant potential to improve human health with huge economic potential. The successful use of these cells relies on standards and harmonization, as well as the comparability and selection of the most effective protocols and cell lines. In providing an international coordination activity and best practice, hPSCreg impacts stem cell-based industries and increase their competiveness.
EU-hPSCreg has a significant advantage for sustainability since it is based on a comprehensive, inclusive database, which already hosts the worldâ€™s largest collection of validated hPSC lines. However, expanding and improving EU-hPSCreg activity will be critical to providing the required international exposure to consolidate its efforts in the new and challenging area of developing hPSC products.