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

由于许多原因(资金、资源、科学等)，在任何再生治疗(RT)中，负责制备/制造(细胞库、生长、培养、纯度和质量保证等)活生物(LB)的卓越中心在地理上与使用点分离。因此，一个主要的挑战是以一种经过验证的、高质量的、“适合目的”的形式向临床提供LB。纵观全球市场，迫切需要在至少几天到一周的时间内保持关键的银行业务特征。尽管适用于较长期的银行业务，但由于公认的对银行业务的负面影响，最终产品的冷冻不是一种选择。同样重要的是，该系统在护理时需要简单、快速和易于使用，以便于临床医生吸收。我们最近的金砖四国授权拨款表明，藻酸盐凝胶细胞封装系统可以满足许多这些需求。我们有越来越多的证据表明，它在室温条件下长期保存多种细胞类型(包括干细胞)是有效的。然而，还需要进一步的研究来充分了解它是如何工作的，并证明该技术可以在工业环境中实施(即可扩展)。

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).