Pluripotent stem cell lines (PSC), either hESC or hiPSC, to be used in biomedical research will be registered and banked at the BNLC (ORDEN SCO/393/2006). The registration will be made according to the following minimal criteria:
1. PSC lines will be obtained in the frame of a research project authorized by state or regional authority and by the Comisión de Garantías para la Donación y Uso de Células y Tejidos Humanos.
2. The research must have been carried out following the ethical principles and the applicable regulations, with special attention to the Law 14/2007, on biomedical research.
3. Registration and banking, either hESC - hiPSC, must have the authorization from the legal representative of the Institution/Department where those lines have been generated.
4. Requesting institution will keep donor’s identity data strictly confidentially, according to Personal Data Protection regulation.
5. Application Form to register and bank of a human cell line must contain detailed information about cell line viability, potential and security, in order to evaluate if the cell line meets stablished standard for the BNLC for transfer and use in research.
6. Cell derivation must guarantee line’s traceability.
Characterization and registration: minimal requirements
hiPS nomenclature (BNLC)
Application Form for the Registration and banking of a hESC
Application Form for the Registration and banking of a hiPSC
Guidelines for the registration of hESC and hiPSC lines generated in Spain in the Human Pluripotent Stem Cell Registry
Informed consent requirements for research involving hiPSC