Cell labelling for in vivo use and in-process quality control

未来将细胞用作治疗和药物发现工具，解决了与一系列医疗条件相关的巨大未满足的社会和临床需求，其中许多目前没有有效的治疗选择，并代表着巨大的疾病负担。在过去的10年里，利用活的人类细胞创造新疗法的可能性已经成熟到一个小数量的疗法存在的程度，一个新兴的行业可以清楚地确定。Cryoskin就是这样一种产品，它是一种积极的治疗烧伤和难以愈合的伤口（如腿部溃疡）。该产品使用的是在选择性材料上生长的供体细胞，这些材料专门设计用于促进细胞生长，但随后允许释放到应用的治疗部位。该产品正在以“喷雾”形式开发，以便于临床应用。然而，必须能够跟踪和定位细胞被喷雾的位置，并使用无毒的试剂，在细胞内停留多代，并且可以简单地用手检测到-在应用后或应用期间保持光源。该提案直接与商业上可行的产品的开发相一致，用GMP合成/配制的细胞标记试剂标记Altrika的Cryoskin产品，已知该试剂以高效方式被细胞吸收。这些将由皇家伦敦医院的团队进行评估，以确保标记不会影响细胞功能，并改善患者护理。这种方法将允许将干细胞输送到临床环境中，并直接跟踪干细胞衍生产品的使用情况。（拥有悠久的细胞输送经验），与世界领先的细胞皮肤伤口护理专家Altrika Limited进行直接的日常互动，Roslin Cellab将评估干细胞功能标签的性质，临床医生（皇家伦敦医院和Barts创伤临床学术单位）将使用贴有标签的Cryoskin产品。

The future use of cells as both therapies and drug discovery tools addresses a huge unmet societal and clinical needrelating to a range of medical conditions, many with no current effective treatment option and representing a hugedisease burden. Over the last 10 years the exciting possibility of creating new therapies using living human cells hasmatured to the extent that a small number of therapies exist and an emerging industry can clearly be identified. Cryoskinis such a product, which is an active treatment for burns and hard to heal wounds (such as leg ulcers). This productoffering uses donor cells grown on selective materials specifically designed to promote cell growth, but then allow releaseto the applied site of treatment. The product is being developed in a "spray" format to allow ease of clinical application.However, it is necessary to be able to track and locate where the cells have been sprayed and to do this using reagentsthat are non-toxic, remain within the cells for multiple generations and can be detected simply using a hand-held lightsource following or during application.This proposal is directly aligned to the development of a commercially viable product, with the labelling of Altrika'sCryoskin product with a GMP synthesised/formulated cellular labelling reagentwhich is known to be taken up by cells in a highly efficient fashion. These will then be evaluated by the team from TheRoyal London Hospital to ensure that the labelling does not affect cell function and that patient care is improved. Thisapproach will allowing the delivery of stem cells into the clinical setting with direct tracking of the stem cell derived productto the point of use.This proposal brings together a synergistic team of chemists in Edinburgh (who have a long history of cell deliveryexpertise) with direct day-to-day interaction with Altrika Limited who are world leading experts in cell based skin woundcare, Roslin Cellab who will assess the nature of the label on stem cell function and clinicians (The Royal London Hospitaland the Trauma Clinical Academic Unit of Barts) who will be using the labelled Cryoskin product.