CVBF provides regulatory, site management, and monitoring support for the AMELIE (Anchored Muscle cELls for IncontinencE) project, Ana Dilo as our Clinical Project Manager of the study oversees and coordinates these activities. AMELIE is a collaborative study funded under the European Union’s Horizon 2020 programme that aims to develop new treatments for faecal incontinence using regenerative medicine approaches.
The project is coordinated by University College London (UCL) under the leadership of Prof. Richard Day.
A total of 13 organizations across 9 European countries including UK, Portugal, Spain, France, Germany, Italy, Austria, Denmark and the Netherlands are collaborating on the initiative. Organisations include universities, hospitals, research institutes, consultants and charities.
CVBF is working on feasibility assessments at the 6 sites that will be participating in the clinical trial. The next steps will involve regulatory submissions and qualification visits to get the sites ready for the trial.
The AMELIE clinical trial will assess the safety and efficacy of using autologous skeletal muscle derived cells combined with microcarriers devices to improve cell viability and increase the likelihood of muscle regeneration, contributing to improved continence.