ISSCR Standards for Human Stem Cell Use in Research were launched in 2021

In 2021, The International Society for Stem Cell Research (ISSCR) released Standards for Human Stem Cell Use in Research aimed at enhancing rigor in preclinical research, improving inter and intra- lab reproducibility and ultimately strengthening the pipeline of therapies for patients and impact of stem cell biology on many aspects of human health and well-being.

At the same time, and arguably, one of the most impactful outcomes was the development of the “Reporting Practices for Publishing Results with Human Pluripotent and Tissue Stem Cells” checklist. This is an important resource for all early career scientists and students coming into the field and will also help established scientists, reviewers, and editors prepare and assess manuscripts for the inclusion of critical details relevant to work with pluripotent stem cells and related technologies.

Update from the recent ISSCR Standards workshop 2024

I recently attended the annual ISSCR 2024 meeting in Hamburg and a highlight was the dynamic and energised session on the progress of the committees within the ISSCR that are rapidly building on and extending the original standard.

The output from The International Society for Stem Cell Research standards and working groups is eagerly awaited and will be another clear step forward in clarifying the requirements for the entire cell therapy (ATMP) development and manufacturing process. 

The session was expertly started by Tenneille Ludwig, who spoke about considerations for cell line traceability and compliance. This was followed by Glyn Stacey, from the UK cell bank ISCBI, who discussed the cell banking working group.

Ricardo Baptista co-chair of working group 3 on ancillary (US) / raw materials (EU) for cell therapy highlighted the risk assessment process. It was great to see the clarity of communication of key points, including that there is no “GMP-grade” for raw materials. Alternative descriptions, such as Cell Therapy grade, to describe reagents manufactured according to GMP principles with extensive quality testing so they can be risk-assessed for use in cell therapy manufacturing were discussed briefly. It will be interesting to see how this nomenclature evolves and if it can be standardised.

The ISSCR standards working group’s intention to provide templates for risk assessment of each type of raw/ancillary materials may be very helpful to the industry.

Other points discussed that are good to note for all translational researchers were

• The need to ensure all CoA and CoO are available for full traceability from the earliest stage of cell therapy development
• The importance of vendor qualification including ensuring you have more than one supplier for each key reagent. This is especially challenging for iPSC therapies as the elephant in the room is we still aren’t sure how variability in the supply chain for media and recombinant protein growth factors and cytokines impacts the interchangeability of essential manufacturing raw/ancillary materials, which is problematic at best.

The Standards documents and checklist are open access and must-read documents:

Standards for Human Stem Cell Use in Research 

Reporting Practices Checklist  

And the Lab Poster is particularly useful and should be up in every stem cell lab.

Catherine Elton, CEO, Qkine