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Provenance and selection of donor tissue
Donor selection and risk factors
• Donor selection for generating hPSC is especially important in terms of clinical application.
• Donor eligibility requires screening for risk factors associated with infection and communicable diseases
viral blood pathogens such as HIV, hepatitis B and C virus, malaria, Chagas disease and human T-cell lymphotropic virus I and II.
• Repositories and banks should have medical information of the donors and their families (anonymized or de-identified) that may be associated with risk of infection or transmission of disease.
PCC Stem Cells - ESHRE BCN 2018
Traceability
• Linkbetweendonorsandcelllines.
• Tracking system to assure a safe and ethical provenance.
• Quality validation.
• Stem cell banks should request history information from the depositor requested by stem cell banks.
• History file: traceability of the cell line from derivation, culture, establishment, transport, testing, banking and storage.
Identifiability
• Information expected to identify an individual alone or in combination with other available information
• hESC research: donor identification based solely on the Single Nucleotide Polimorphysms (SNP) genotype of the cell line is extremely remote. No threat to the privacy and confidentiality of donors.
• hiPSC research: easier donor identifiability.
Concern that current technical and ethical safeguards to protect the identity of donors
could be insufficient.
PCC Stem Cells - ESHRE BCN 2018
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PRECONGRESS COURSE 10 I BARCELONA, SPAIN – 1 JULY 2018 15