VISION

AND OBJECTIVES

Our Mission

The consortium is pioneering a novel translational approach to the manufacture and delivery of anchorage-dependent cells. By enabling cells to be implanted while remaining attached to a supportive scaffold, this technology has the potential to improve regenerative medicine therapies for faecal incontinence and many other clinical applications.

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The Unmet Need

Faecal incontinence affects more than 67 million people across Europe, representing a common but under-recognised public health challenge.
Although not life-threatening, it is classified by the World Health Organisation (WHO) as a disease that can have a profound impact on quality of life, daily functioning, productivity, and healthcare systems.
Despite its prevalence, current treatment options remain limited. They are often invasive, not suitable for all patients, or fail to provide durable long-term benefit, creating a significant unmet clinical need.
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Our Vision

AMELIE is developing a novel tissue-engineered product, classified as a combined advanced therapy medicinal product, in which anchorage-dependent cells are attached to an implantable, biodegradable and clinically qualified microcarrier with the aim of directly improving the clinical symptoms of faecal incontinence.

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AMELIE Objectives

Objective 1:

Establish new robust processes for the manufacturing, characterisation, transportation and delivery of biodegradable, implantable microcarriers

Objective 2:

Demonstrate the safety of the ASMDC microcarriers using non-clinical testing to comply with national regulatory requirements and create a product summary that will enable evaluation of the technology across Europe.

Objective 3:

Conduct a pan-European randomised, double-blind trial to determine whether the microcarriers lead to a reduction in the frequency of FI episodes.

Objective 4:

Involve national and regional societies with support from European charities, patient support networks and the public to establish channels for PPI activity and dissemination of project developments to patients, the public and the scientific community.

Objective 5:

Develop a business plan and future commercialisation strategy to enable patient access to the microcarrier across Europe and the World.