ROSLIN CELLS LIMITED

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This project will assess the feasibility of improving the clinical utility of umbilical cord blood (UCB) through ex vivo expansion mediated by co-culture with mesenchymal stromal cells (MSCs). We have patented technology for the production pluripotent stem cell derived MSCs, which means that we can supply these cells in almost limitless quantities. The haematopoietic stem and progenitor cells found in UCB are of immense clinical value and our MSCs exhibit several advantages over bone marrow derived MSCs. Over half of all UCB units cannot be used clinically as they lack sufficient quantities of haematopoietic stem or progenitor cells. This feasibility project will build on patented and other prior work and create the opportunity to establish a significant business with important clinical impact.

A BBSRC funded collaborative research at Heriot-Watt and Edinburgh Universities has resulted in the development of novel engineering technology to separate human stem cells from specialised cells that originate from them. Unlike currently practiced approaches, the new technique does not rely on surface attachment of probes that may alter cell behaviour. The probe-free separation technology has applications in the isolation and processing of stem cells for industrial drug discovery and cell manufacturing for clinical application. To develop these applications further it is necessary to (1) secure funding from sources supporting non-academic development of a commercial product, and (2) identify and engage industrial and clinical end users. Academic institutions are not generally effectively positioned or best experienced in acquisition of this type of funding or to commercially engage with others. The purpose of this award therefore is to interchange Dr Marieke Hoeve, a senior academic researcher with a background in immunology, cell biology & stem cell research, and experience in academic project management, from the laboratory of Dr. Paul De Sousa at Edinburgh University, first to Heriot-Watt University to learn the underpinning engineering technology of the engineering scientists and acquire experience in academic technology transfer office practice. This is followed by a placement at a stem cell contract manufacturing organisation, Roslin Cells Ltd, whose remit is to facilitate industrial and clinical translation of stem cell research. Lastly Dr Hoeve will return to the applicant's lab to apply the multi-disciplinary experience gained. In this placement Dr Hoeve will aim to: 1. Gain experience in the acquisition of funding for non-academic commercial product development for Roslin Cells. 2. Acquire industrial project management experience by contributing to management of existing Roslin Cells projects. 3. Prepare a market analysis of the demand and competition for the cell separation technology. 4. Secure funding for the application of the probe-free cell separation technology for inducing pluripotent stem cells from adult cells that resemble embryonic stem cells, for purposes of modelling diseases in a 3-way collaboration between Roslin Cells, the University of Edinburgh and Heriot-Watt. 5. Secure funding for application of the probe-free cell separation technology in other industrial and clinical applications in a collaboration between the aforementioned and other academic and commercial end users.

The vision for Edinburgh's Centre for Mammalian Synthetic Biology (SynthSys-Mammalian) is to pioneer the development of the underpinning tools and technologies needed to implement engineering principles and realise the full potential of synthetic biology in mammalian systems. We have an ambitious plan to build in-house expertise in cell engineering tool generation, whole-cell modelling, computer-assisted design and construction of DNA and high-throughput phenotyping to enable synthetic biology in mammalian systems for multiple applications. In this way we will not only advance basic understanding of mammalian biology but also generate tools and technologies for near-term commercial exploitation in areas such as the pharmaceutical and drug testing industries, biosensing cell lines sensing disease biomarkers for diagnositics, novel therapeutics, production of protein based drugs e.g. antibodies and also programming stem cell development and differentiation for regenerative medicine applications. In parallel we will develop and implement new understanding of the social and economic impact of this far-reaching technology to ensure its benefits to society.