ISCBI Scoping plans

Workplan for the International Stem Cell Banking Initiative

The ISCF represents a unique forum for supporting activities in stem cell research that require integrated international collaboration. Forum members have agreed that stem cell banking is one such activity that would benefit significantly from coordination of international efforts, which should aim to promote:

Two phased meetings will be held under the initiative. These will gather together experts from stem cell research with additional input from experts in other relevant fields, including regulatory agencies. The first meeting is to focus on international standards for supplying stem cell lines and the second on issues for the clinical application of stem cells.

Meeting one: coordination of suppliers of stem cell lines for stem cell research

The first meeting will bring together laboratories which have established, or are aiming to establish, service culture collections of hES cells. It will draw on international expertise in appropriate regulatory issues and specialist technologies such as cryobiology, cell engineering and toxicology.

Meeting two: coordinating international standards on issues relating to the clinical application of stem cells

The outcomes of the first meeting will inform the establishment of a specialist group with experience in, or imminent intention to supply, stem cells for clinical applications. A meeting of this group will consider the critical issues for progressing stem cell lines, including research developments in culture, the differentiation of stem cells to deliver reliable and validated cell banks, and protocols for clinical trials. Expertise will be incorporated from those working with bone marrow and blood-derived stem cells and national and international regulatory bodies.

The meeting is likely to raise issues that would require a longer-term programme of development, and could be used to initiate a series of activities to help establish the ground rules for development of therapies based on stem cells and, particularly, stem cell lines. This meeting could be expected to include discussion on:


Issues to be addressed at the meetings

Generic issues that might be addressed include:


Intended outputs from the meetings

An immediate output from the first meeting will be a consensus report on critical issues and fundamental principles for the maintenance of stem cell banks. Agreement will also be sought on the need for further outputs that require more time. These might include:

To disseminate the outcomes, which will be important to many stem cell researchers, the intention is to publish the initial meeting report and subsequent outputs in stem cell journals.

A report will also be produced and published from the second meeting on banking of clinical grade stem cells. Other outputs from this meeting might include:


Conclusion

The ISCF banking initiative will aid the development of international efforts on harmonisation and best practice for preparation of high quality cells for research. It will also provide a key forum for rigorously evaluating some of the requirements for the clinical application of stem cell lines. The project should also stimulate further international initiatives to deliver safe and reliable stem cell therapies for the future.

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