On July 14, a joint meeting of the International Stem Cell Biobanking Initiative (ISCBI), International Stem Cell Initiative (ISCI), and HAPLO-iPS (Cost Action CA21151: Generation of human induced pluripotent stem cells from haplo-selected cord blood samples) was held at the University Campus in Hamburg-Eppendorf.
Approximately 60 people participated on-site (including ~30 HAPLO-iPS members), and another 25 people joined the meeting virtually. On behalf of HAPLO-iPS, members of Working Groups 3 (QC, biobanking, and registration of cell lines), 4 (Safety and Regulation), and 5 (Management, data handling, and Ethics) took part.
The main topics of the event were the international efforts in stem cell standardization and the status of the related regulatory pathways. The meeting allowed for the discussion of a wide range of emerging issues and the latest developments related to pluripotent stem cells and stem cell banking.
The first part of the meeting began with a presentation by Glyn Stacey who introduced the current activities of the International Stem Cell Biobanking Initiative. The next speaker was Martin Pera, who discussed the issues related to the genetic stability of pluripotent stem cells. In the next speech, Tadaaki Hanatani presented the plans of the CiRA Foundation and outlined the project of the Japanese iPSC haplobank. Jack Mosher and Tenneille Ludwig‘s presentation referred to the current best practice for the translation of PSC-based therapies. In the next presentation, Begoña Aran from HAPLO-iPS presented the goals of this project, its structure, and achievements. Subsequent talks concerned Chinese and ISO Standards for stem cell and cell therapies (Tongbiao Zhao) and Good Cell Culture Practices for the generation of hPSC-derived organoids (David Pamies). The morning part of the meeting ended with a speech by Lucia Aspiroz and Milena Mennecozzi on standards for stem cells in non-clinical research.
During the latter half of the meeting, Gerald Schumann discussed the possible applications of hPSC-based products from the European regulatory authorities’ viewpoint. Subsequently, Nancy Mah introduced the concept of LIFCU (Lines Intended for Clinical Use) and challenges pertaining to such cell line databases. The meeting ended with brief presentations by the leaders of the HAPLO-iPS project Working Groups – WG3 (Andreas Kurtz), WG4 (Andras Dinnyes), WG5 (Joel Glover), followed by a panel discussion focusing on the crucial aspects of regulatory development of hPSC-based drug products.