GAiT is currently building a specialised database for clinical grade iPSCs. This will take several months to build, test, and get online. In the meantime, GAiT recommends that information about candidate lines be registered on the hPSCReg database (Seltmann et al., 2016). This database is developed for research-grade iPSC lines but many of the categories for information deposition are similar to that that will be required by the GAiT database.
Ethical approval information and scientific information can also be included in the hPSCReg database. The requirements that hPSCReg database makes depositors go through, ensure they collect all pertinent information and such registered lines are useful throughout most of Europe and are very similar to the format used by NIH in the USA.
The hPSCReg database contains information on over 1,000 human pluripotent stem cell lines, including the EIBSC catalogue of cells, and the design of the hPSCReg database allows transfer of information to the new GAiT database so most of the material will not require re-insertion when the new database is operational. Many countries look to hPSCReg for validation of cell lines. Grants are dependent on hPSCReg issues certificates. The European Commission sees the benefits of getting a hPSCReg certificate as they do not presently have to re-contact the originator / deriver of the lines and start from scratch to confirm ethical provenance.
Table showing Mandatory Donation, Procurement, and Testing Data Fields for clinical-grade iPSCs in the GAiT’s haplobank system
| Donation, Procurement & testing of celluar | Permissiveness of donor consent | Consent Form | Research use? |
| Genetic analysis? | |||
| Commercial use? | |||
| Attestation | |||
| Donor selection criteria | Immunotyping | Bloodtype | |
| HLA Type l | |||
| HLA Type ll | |||
| KIR | |||
| Regulatory compliance | Establishment type | ||
| GMP status | Compliant? | ||
| Licence/Registration status | 2004/23/ECcompliant? (EU) | ||
| 2002/98/EC compliant? (EU) | |||
| Part 1271 compliant?(US) | |||
| CTO Regulation? (Canada) | |||
| CSA compliant? (Canada) | |||
| Category 1 Outsourcing inst? (Japan) | |||
| Category 2 Outsourcing inst? (Japan) | |||
| Category 3 Outsourcing inst? (Japan) | |||
| Accredition | AABB? | ||
| AATB? | |||
| FACT? | |||
| Other? | |||
| Donor health assessment and donor testing | General | Sex | |
| Age | |||
| Geographic Location | |||
| Year | |||
| Tissue Type | |||
| Infectious disease | Screening According to local requirement | ||
| Physcial Exam |
While registering the lines is not a legal requirement in many countries like the USA, it was strongly encouraged by GAiT and others, as it assists the standardisation of nomenclature which can then be used thereafter.
Nomenclature length and format is important so all the information can be transcribed onto a single cryovial. Consequently, nomenclature development must be done systematically as one cannot depend on the line originators / derivers to adhere to any format that can be fit on a vial (Seltmann et al., 2016). Registering the line also allows unique nomenclature to be used, reducing the risk of confusion in the literature or research studies thereafter.
Inputing the information into hPSCReg database and gaining approval, allows the user to format information relating to cell provenance and characterisation which in itself will act as a useful data checklist and give depositors greater surety that their line will ultimately be accepted into the GAiT clinical-grade database.
The GAiT Clinical Grade iPSC search engine and database is currently being developed.
The database forms a vital part of the initial attrition process for source material suitability. By doing this prior to full line generation and registration into banking system, extensive waste and expense will be avoided.
To access the Database, users are asked to register with GAiT. [Link to username/password request]
References
ANDREWS, P. W., BAKER, D., BENVINISTY, N., MIRANDA, B., BRUCE, K., BRUSTLE, O., CHOI, M., CHOI, Y. M., CROOK, J. M., DE SOUSA, P. A., DVORAK, P., FREUND, C., FIRPO, M., FURUE, M. K., GOKHALE, P., HA, H. Y., HAN, E., HAUPT, S., HEALY, L., HEI, D. J., HOVATTA, O., HUNT, C., HWANG, S. M., INAMDAR, M. S., ISASI, R. M., JACONI, M., JEKERLE, V., KAMTHORN, P., KIBBEY, M. C., KNEZEVIC, I., KNOWLES, B. B., KOO, S. K., LAABI, Y., LEOPOLDO, L., LIU, P., LOMAX, G. P., LORING, J. F., LUDWIG, T. E., MONTGOMERY, K., MUMMERY, C., NAGY, A., NAKAMURA, Y., NAKATSUJI, N., OH, S., OH, S. K., OTONKOSKI, T., PERA, M., PESCHANSKI, M., PRANKE, P., RAJALA, K. M., RAO, M., RUTTACHUK, R., REUBINOFF, B., RICCO, L., ROOKE, H., SIPP, D., STACEY, G. N., SUEMORI, H., TAKAHASHI, T. A., TAKADA, K., TALIB, S., TANNENBAUM, S., YUAN, B. Z., ZENG, F. & ZHOU, Q. 2015. Points to consider in the development of seed stocks of pluripotent stem cells for clinical applications: International Stem Cell Banking Initiative (ISCBI). Regen Med, 10, 1-44.
CARPENTER, M. K. & RAO, M. S. 2015. Concise review: making and using clinically compliant pluripotent stem cell lines. Stem Cells Transl Med, 4, 381-8.
SELTMANN, S., LEKSCHAS, F., MULLER, R., STACHELSCHEID, H., BITTNER, M. S., ZHANG, W., KIDANE, L., SERIOLA, A., VEIGA, A., STACEY, G. & KURTZ, A. 2016. hPSCreg–the human pluripotent stem cell registry. Nucleic Acids Res, 44, D757-63.
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If you would like to gain access to the iPSC database, please contact admin at: stephen.sullivan@gait.global
