ISCBI October 2007
18-19 October 2007, Bar Harbor, Maine
The meeting aimed to:
- Consider the key issues in provision of reliable and reproducible samples of stem cell lines and their distribution on an international basis.
- Consider existing guidance on the various topics discussed and identify any gaps that may need to be filled.
- Provide a summary of the generic issues for stem cell banks, give guidance on current best practice for stem cell banking and establish a forward plan on issues that require further development.
Promote interaction and coordination between the active banks, based on issues of common concern.
Items discussed:
- Banking procedures to maximise longevity of lines (including facilities, protocols and cryopreservation).
- Operational frameworks, documentation and data management systems needed for stem cell banks.
- Assuring adequate and robust quality control.
- The need for safety testing of cell lines.
- Delivery of effective ethical governance.
- Efficient international transfer of cells.
- Effective data handling (for managers of cell banks) and user information.
Potential outputs:
‘Code of Practice’ for research stem cell banks
A concise published summary of the points to consider when setting up a bank, including what systems are needed, would be very valuable. It could give helpful guidance on what the group considers to be current best practice and differentiate between what is ‘required’ and what is ‘desirable’.
Other guidance and route-maps to information and support
These may include:
- Special aspects of quality control, safety and characterisation.
- International transfer of cells.
- International ethical regulation.
- Training and quality control services.
Enhanced coordination of cell line supply
- This could be done initially through an ISCF stem cell supply group, comprising those active in national or international distribution as a routine operation. Ultimately, this could be self-supporting or be adopted by the stem cell or culture collection community.
- Application of the code in research labs and training initiatives: this could be carried out through stem cell-related organisations and other appropriate scientific societies.
Programme:
Thursday 18 October
- Introductions and short presentations by groups distributing lines –intended as a way to outline the different kinds of cell bank represented at the meeting.
- Open discussion to review and agree the key issues for stem cell banks and which of these issues will be the focus of discussion.
- Break-out sessions on key topics.
- Feedback from breakout sessions and discussion.
- Compilation of notes overnight.
Friday 19 October
- Review of output from previous day.
- Brain-storming session: perspectives from the stem cell field on ‘quality’ of cells.
- Preliminary open discussion on required outputs from breakout sessions to follow.
- Breakout sessions on current best practice, to provide detailed descriptions, preliminary references and existing standards for:
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- Stem cell characterisation.
- The banking process.
- Quality control and safety testing.
- Basic requirements for ethical sourcing and transfer of cells across regulatory boundaries.
- IP and patenting issues.
- Feedback from break-out sessions and open discussion on these topics.
- General discussion on:
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- Gaps in recommendations or available guidance.
- Forward plans to complete/disseminate output and coordination of stem cell banks.
- Issues for clinical grade stem cell meeting.
- Conclusion.
