Validating human embryonic stem cell lines listed in hESCreg
A validation process has been initiated to provide users with two essentially new pieces of information in hESCreg:
- That human embryonic stem cell lines listed on hESCreg comply with the EU’s fundamental ethical principles for hESC research
- Listed cell lines have a minimum of characterization data that will qualify them as truly pluripotent human embryonic stem cell lines
Based on completeness of this information individual cell lines will be reviewed by the hESCreg Scientific Advisory Board (SAB) in a procedure outlined in the hESCreg Code of Practice. Cell lines that have successfully passed this review will be listed as “Validated”.
Originators and providers of human embryonic stem cell lines are requested to review the data on their cell lines entered in hESCreg, and in particular, to complete the Registration Information.
New to this section is the requirement to provide blanked copies of the documentation of the donors’ informed consents and the traceability measures in place. Other new information requested regards the maximum passage level to which the cell line has been stably maintained and the morphology of the cell line. Differentiation assay information now only needs to be provided for one method, i.e. in vitro OR in vivo.
Cell lines with full Registration Information are then listed as “Completed”, which will trigger the validation by hESCreg’s SAB. Cell lines in the process of completion are listed as “Incomplete”.
The Validation Process
Originators and Providers of cell lines wishing to complete the information on their cell lines and to initiate their validation are requested to log in and re-authenticate themselves by entering a new password. In addition to the completion of missing registration information confirmation of the cell lines’ compliance with the fundamental ethical principles is sought in a new section in “My hESCreg” called “Ethical Confirmation of Cell Lines”.