Role of CVBF
Faecal incontinence (FI) is a common condition affecting around 67 million people in Europe, seriously impairing living and productivity of affected individuals and their families. Women with FI arising from childbirth injury may benefit from regenerative medicine using autologous skeletal muscle derived cells (ASMDC) to restore function of damaged sphincter muscle. However, progress is hindered by sub-optimal manufacturing and delivery techniques contributing to inconsistent results.
AMELIE proposes an innovative approach that uses ASMDC attached to implantable microcarriers that will enable delivery of a higher number of viable ASMDC into the damaged sphincter muscle, increasing the likelihood of cell engraftment, regeneration of muscle and improved continence. To achieve this aim, AMELIE will develop bespoke implantable microcarriers suitable for clinical use; establish robust bioprocessing for manufacture of the cell-microcarrier combination; and for the first time, robustly test, in a randomized clinical trial, the principle that delivery of ASMDC in an anchored, natural state, provides more effective and consistent treatment.
The AMELIE project comprises a highly interdisciplinary consortium of internationally recognised experts and key-opinion leaders with relevant experience from academia and industry across Europe in the fields of engineering, biological sciences, and translational regenerative medicine. Dissemination activities and stakeholder interaction with patients and the public, healthcare professionals, industry and third party FI charities across Europe will focus on establishing reciprocal dialogue with people that will interact with the new technology throughout the lifetime of the AMELIE project. Experts in knowledge management and exploitation will develop a marketing strategy and business plan to facilitate future exploitation of the technology to ensure patient benefit.
CVBF is involved in the AMELIE project as the beneficiary in charge of CRO-like activities, providing support to the Sponsor and the sites in the conduct of the study. CVBF activities include clinical study management, regulatory procedures (VHP, submissions to regulatory authorities and ethics committees), TMF management, pharmaco-/materio-vigilance, and monitoring.
European Union’s Horizon 2020 call “Better health and care, economic growth and sustainable health systems) under grant agreement n° 874807
Euro 9.5 million
University College London – UK (Coordinator), Instituto Superior Técnico – PT, Queen Mary University of London – UK, Medizinische Universität Graz – AT, Aarhus University Hospital – DK, Université de Rouen Normandie – FR, Universitätsklinikum Erlangen – DE, Instituto Investigacion Sanitaria Fundacion Jimenez Diaz – ES, NHS Blood and Transplant – UK, Polysciences GmbH – DE, ttopstart BV – NL, Bowel & Cancer Research – UK, Consorzio per Valutazioni Biologiche e Farmacologiche – IT