OUR RESEARCH

Faecal Incontinence: Impact on Patients

Faecal incontinence is a substantial public health problem. The condition can severely affect everyday life, including:

  • dignity and confidence
  • wellbeing and mental health
  • independence
Many individuals experience:
  • anxiety
  • social isolation
  • reduced participation in work and travel
  • limitations in daily activities
The AMELIE project focuses specifically on faecal incontinence resulting from injury to the anal sphincter, most commonly following:
  • childbirth
  • surgery
  • trauma
Women who have given birth represent a large proportion of affected individuals, with around 5.5% experiencing direct injury during childbirth due to perineal tearing.

Faecal Incontinence and Regenerative Medicine

Regenerative medicine seeks to repair or replace tissue that has been damaged by ageing, disease or injury, offering new possibilities for treating faecal incontinence caused by injury to the anal sphincter. Among regenerative approaches, cell therapy using autologous skeletal muscle-derived cells (ASMDCs) to regenerate the damaged external anal sphincter has been the most extensively investigated.

Europe has played a leading role in translating this approach into clinical practice. Of the five published clinical studies of cell therapy for faecal incontinence, three were conducted by European research groups and used ASMDCs delivered as a cell suspension. In the Phase II randomised placebo-controlled trial, only 58% of patients receiving ASMDC therapy responded after 12 months, while open-label pilot studies reported similar levels of subjective improvement. Overall, these studies have demonstrated only modest clinical benefit, suggesting that current cell delivery methods do not consistently achieve the desired therapeutic effect.

Why Are Conventional Methods Not Delivering Better Results?

Many of the cells used in regenerative medicine, including autologous skeletal muscle-derived cells (ASMDCs), are anchorage-dependent, meaning they must remain attached to a surface in order to grow and function normally. In conventional manufacturing, these cells are isolated from the patient, expanded in the laboratory while attached to a culture surface, and then detached before being administered as a cell suspension.
To date, all published clinical studies of cell therapy for faecal incontinence have used this conventional manufacturing approach. However, detaching cells from their culture surface before transplantation can damage them, reducing their viability and regenerative potential. This process can also trigger anoikis – a form of cell death that occurs when anchorage-dependent cells lose contact with their supporting surface.
Poor cell survival after transplantation is one of the major challenges facing regenerative medicine. For therapies that rely on cells integrating into damaged muscle, such as treatments for faecal incontinence, low cell survival can limit effectiveness and contribute to inconsistent clinical outcomes.
Addressing this challenge is at the heart of the AMELIE project. By developing an implantable cell–microcarrier therapy that allows cells to remain attached to a supportive scaffold during transplantation, the consortium aims to improve cell survival, enhance tissue repair and deliver better outcomes for patients.