Faecal incontinence (FI) is a common condition affecting ~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, 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 clinical trial, the principle that delivery of ASMDC in an anchored, natural state, provides more effective and consistent treatment. AMELIE comprises a highly interdisciplinary, gender balanced, consortium of internationally recognised experts and key-opinion leaders with relevant experience from academia and industry across Europe in the fields of engineering (IST, PS, UCL, NHSBT), biological sciences (NHSBT, UCL, IISFJD), and translational regenerative medicine (QMUL, MUG, AUH, AU, RUH, UHE, IISFJD, CVBF). BCR will lead dissemination activity and stakeholder interaction with patients and the public, healthcare professionals, industry and third party FI charities across Europe to establish reciprocal dialogue with people that will interact with the new technology throughout the lifetime of the AMELIE project. TTOP will lead knowledge management and exploitation to develop a marketing strategy and business plan to facilitate future exploitation of the technology to ensure patient benefit.

Aarhus University Hospital, Pelvic Floor Clinic, Department of Surgery, will participate in the clinical part (WP6) of the study, where muscle biopsies are taken from the m. pectoralis major, these are cultured. After approx. 8 weeks these cultured muscle cells are injected into the external anal sphincter in patients suffering from FI due to external anal sphincter disruption. It is believed that the cultured cells will empower regeneration of muscle and improved continence.