BENEFITS

OF AMELIE

Potential new regenerative therapies to address unmet clinical needs of large patient groups identified.

Europe’s position in translational regenerative medicine strengthened.

New therapies for major human diseases and conditions, and new approaches for therapy taken further in the development pipeline.

Potential new regenerative therapies to address unmet clinical needs of large patient groups identified

Faecal incontinence is a common condition affecting approximately 9% of adults in Europe. However, this figure is likely underestimated, as around 70% of individuals do not seek medical advice. Of those who do consult a healthcare professional, only a proportion pursue further treatment, and approximately half are not suitable for currently available options.

The AMELIE approach offers several advantages over existing surgical interventions, which can carry risks such as infection, pain, and device failure or dislocation, sometimes resulting in the need for a permanent stoma. Improved continence outcomes have the potential to benefit not only patients, but also carers and individuals on nursing home waiting lists.

If effective, treatment using implantable cell–microcarrier technology could significantly improve quality of life for citizens across Europe. Presenting this therapy as a realistic option for restoring continence, rather than solely managing symptoms, may also encourage more patients to seek medical advice, thereby increasing access to treatment.

Europe’s position in translational regenerative medicine strengthened

Europe is world-leading in cell-based therapies for patients with FI. As well as reinforcing Europe’s dominant role in the field, AMELIE also represents a step-change in the approach being taken to manufacture and deliver cell-based medicine that will enable European citizens to be the first worldwide to benefit from a pioneering new approach to regenerative medicine.

Cell therapy is a rapidly growing area of research. Tissue engineered products are set to grow significantly and provide substantial opportunities to strengthen Europe’s position in translational regenerative medicine. Europe is responsible for approximately 26% of global regenerative medicine companies. The development of innovative technology such as implantable TIPS microcarriers will draw investment to Europe. AMELIE then seeks to advance the competitive positions of European companies as providers of innovative enabling technologies for regenerative medicine. This will enhance AMELIE’s exploitative potential.

New therapies for major human diseases and conditions, and new approaches for therapy taken further in the development pipeline

AMELIE paves the way for identical or similar innovative treatments using ASMDC cell-microcarrier combinations for a variety of other clinical conditions associated with loss of skeletal muscle function, such as urinary incontinence, muscular dystrophies and volumetric muscle loss associated with trauma injury.

The same scientific rationale and new approach developed in AMELIE is equally applicable to other anchorage-dependent cell types investigated as new regenerative medicine treatments. New products comprised of these anchorage-dependent cells are intended to treat some of the most debilitating diseases that affect muscle, bone, cartilage, ocular, heart/cardiovascular, gastrointestinal/liver, kidney, immune and respiratory tissues. Adoption of the implantable TIPS microcarrier technology could have a significant impact on their outcome.

Meanwhile the scale-up manufacturing process for TIPS microparticles developed can be applied to other uses of the microparticle technology currently being investigated in the development pipeline.