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

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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.