The AMELIE project has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement No 874807.
Richard Day
Professor of Regenerative Medicine Technology, University College London
Charles Knowles
Professor of Surgery at Queen Mary University of London and consultant colorectal surgeon at the Cleveland Clinic London
Patients whose lives have been impaired by faecal incontinence are offered new hope with proposed technology that offers a cure, rather than management, of their condition.
In her 20s, Joanne suffered a fourth-degree vaginal tear during childbirth. It resulted in a traumatic injury to her anal sphincter — the muscles that control bowel continence — leaving her with faecal incontinence, urinary incontinence and nerve damage. She still managed these debilitating conditions nearly two decades later.
Limited treatment options for faecal incontinence
Depending on the severity, treatment options can include changes to diet and lifestyle, diarrhoea medication, behavioural therapy and pelvic floor physiotherapy. In some cases, patients may be fitted with a neurostimulator, a pacemaker-like device generating electrical impulses to the sacral nerves to improve communication between the bowel and brain. In others, sphincter repair surgery may be necessary.
Yet, when she first sought help, Joanne felt dismissed by some medical professionals. “If women are told that a ‘difficult’ birth is bound to make them a ‘bit incontinent,’ they feel like they’re making a fuss,” she says.
Life-changing impact of faecal incontinence
Joanne finally had surgery two years later, but the tissue damage was so extensive that a full sphincter repair was not possible. “I was left with frequent faecal and urinary incontinence,” she says. “Plus, the nerve damage meant that I didn’t always know when I needed to go to the toilet.”
A sacral nerve stimulator has reduced the number of incontinence episodes, but her quality of life remains severely impaired. “I can’t put into words the impact this condition has,” she says. “Before I go out, I need to know where the nearest toilets are. I need to have spare clothes, pads and antibiotics in case of infection.”
Incontinence induces two of the most
powerful human emotions: fear and shame.
Regenerative medicine offers promise to patients
The trauma of incontinence can be psychologically scarring, too. “Incontinence induces two of the most powerful human emotions: fear and shame,” explains Charles Knowles, Professor of Surgery at Queen Mary University of London and consultant colorectal surgeon at the Cleveland Clinic London.
However, the promise of regenerative treatment offers new hope to patients with faecal incontinence. Professor Knowles is also Clinical Chief Investigator of a five-year, €9.5 million collaborative research project called AMELIE (Anchored Muscle cells for Incontinence) involving 13 organisations across nine European countries.
Coordinated by University College London (UCL) and led by Richard Day, Professor of Regenerative Medicine Technology, the AMELIE project aims to use revolutionary cell therapy to find a cure for a condition that affects approximately 67 million people in Europe alone.
“The new technology takes muscle cells collected from the patient via biopsy and anchors them to small, dissolvable polymer microspheres; each about the size of a grain of salt,” says Professor Day. “Injecting cells back into the patient in a more natural, anchored state improves delivery in the hope that more of them will survive and engraft with the patient’s sphincter muscle, thus promoting regrowth and improving continence.” Unlike surgery, this pioneering procedure is minimally invasive.
Aiming for a new cure
The first clinical study using the technology is due to begin in early 2025 and will include women whose incontinence has been caused by trauma sustained during childbirth. However, Professor Knowles admits: “Even if the study goes well, there will be hurdles to cross before it can be made accessible to patients.”
Yet, Professor Knowles and Professor Day are excited by its possibilities. “Existing treatments simply manage the condition,” says Professor Day. “AMELIE will ideally be a one-off treatment to restore sphincter function.” The technology may also be useful in other areas of regenerative medicine.
Though Joanne is not participating in the study, she is acting as a patient adviser to the project. “If the trauma caused by vaginal tears can be identified earlier, and if this new treatment is a success, women won’t need to endure years of shame, fear and lack of freedom,” she says. “That could be life-changing.”
To learn more, visit amelie-project.eu and ucl.ac.uk/day-lab
