Investigation of optimal gel conditions for stem cell preservation at room temperature and scaling up of selected methodology

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For numerous reasons (financial, resource, scientific etc) the centres of excellence responsible for the preparation/manufacture (cell banking, growth, culture, purity and QA etc) of the Living Biologic (LB) in any Regenerative Therapeutic (RT) are geographically separated to that of the point of use. Therefore, a major challenge is to deliver to the clinic the LB in a validated, quality, 'fit for purpose' form. Across the global market place there is a pressing need to retain the key LB characteristic for at least several days to one week. Although suitable for longer term banking, Cryofreezing for the final product is not an option due to the acknowledged negative effects on the LB. As important, the system needs to be simple, rapid and easy to use at the point of care in order to ease uptake by the clinician. Our recent BRIC enabling grant has shown that an alginate gel cell encapsulation system meets many of these needs. We have a growing body of evidence that demonstrates it is effective at preserving a number of cell types (including stem cells) over extended periods in room temperature conditions. However, further research is needed to fully understand how it works and demonstrate that the technology can be implemented in an industrial setting (i.e. scalable).