Project description
A targeted regenerative approach for treating incontinence
Faecal incontinence (FI) is the inability to control bowel movement, causing leakage of faeces. The EU-funded AMELIE project comprises a highly interdisciplinary consortium of experts who are proposing a novel regenerative intervention using autologous skeletal muscle derived cells (ASMDC) to restore the function of the sphincter muscle. Scientists will attach ASMDC to implantable microcarriers to improve cell delivery and engraftment in patients with FI. This will be tested in a randomised clinical trial. The strategy is expected to improve cell viability and increase the likelihood of muscle regeneration, contributing to improved continence.
Objective
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 randomised 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.
Fields of science
Programme(s)
Funding Scheme
RIA - Research and Innovation actionCoordinator
WC1E 6BT London
United Kingdom