CompletedPhase IInterventional

Anchored muscle cells for incontinence

This study is for women who experience accidental bowel leakage (faecal incontinence) following childbirth, often due to tears in the muscles around the back passage. This problem can significantly affect daily life. Researchers are testing a new treatment that uses your own muscle cells to help repair these injured muscles. They take a small sample of muscle from your chest, grow the cells, and then mix them with tiny carriers before injecting them into the affected muscle. This early-stage study (Phase I) is mainly to see if this new treatment is safe. They will also observe if it helps reduce leakage episodes and improves your quality of life. All participants receive the same treatment, and you'll have several visits over a year.

At a glance

Status

Completed

Phase

Phase I

Sponsor

University College London

Enrolment target

Start

15 Dec 2025

Estimated completion

13 Feb 2026

Faecal incontinence (FI) in women with obstetric anal sphincter injury

What is this study about?

For many women, childbirth can sometimes lead to tears in the muscles that control their bowels, known as the anal sphincter. This can unfortunately cause accidental bowel leakage, which doctors call faecal incontinence. It's a common problem that can be really upsetting and impact everyday life.

This study, called "Anchored muscle cells for incontinence," is exploring a new way to help these women. The idea is to use your body's own muscle cells to repair the damaged area. Think of it like taking a small piece of muscle from your chest, growing lots of new muscle cells from it in a lab, and then putting those new cells back where they're needed. These cells are combined with very small, specially designed particles when they're injected.

This is a 'Phase I' study, which means it's one of the very first times this specific treatment will be tested in people. The main goal at this stage is to make sure the treatment is safe. Researchers will also be carefully watching to see if it helps reduce the number of leakage episodes you experience and improve your overall comfort and quality of life. All participants will receive the active treatment, and the study will follow your progress for a year.

Key takeaways

Targets women with bowel leakage from childbirth injuries.
Uses your own muscle cells to potentially repair damaged areas.
Early-stage study focused on treatment safety and effectiveness.
Involves a small muscle sample and then an injection of your cells.
Requires 11 visits over a 12-month period.
Potential for unknown risks as it's a new treatment.

Who may be eligible?

This study is looking for women who are 18 years or older and have been experiencing ongoing accidental bowel leakage. To be considered, you must also have a history of having had a muscle tear around your back passage during childbirth. Doctors will need to confirm that you've tried usual treatments for bowel leakage, such as lifestyle changes or medications, and they haven’t worked well for you.

There are also some specific criteria regarding how often you experience bowel leakage; for example, you need to have at least eight episodes of leakage or urgency over a four-week period.

You cannot join if you've had recent surgery to repair your anal muscle, or if you have certain other serious health issues like some long-term illnesses, infections, or very recent cancer. If you are pregnant, planning to become pregnant, or breastfeeding, you also won't be able to take part. Your doctor will carefully check all these details to see if this study is right for you.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you a woman aged 18 or over?
Do you experience ongoing accidental bowel leakage?
Did your bowel leakage start after muscle damage during childbirth?
Have you tried other treatments for bowel leakage that haven't worked well?
Do you get at least 8 episodes of bowel leakage or urgency in a month?
Are you not currently pregnant or planning to be during the study?

Answer every question to see your result.

What does participation involve?

If you decide to take part, the study will involve 11 visits over a year. The main part of the treatment involves two steps. First, surgeons will take a tiny piece of muscle from your chest – this is like a small biopsy. This sample will then be sent to a lab where your muscle cells will be grown and specially prepared.

After your cells are ready, they will be injected into the muscles around your back passage. Everyone in this study will receive this new treatment. During your visits, the study team will carry out health checks, ask you questions about your bowel leakage, and you might fill out questionnaires or keep a diary. They will compare your symptoms before the treatment with how you feel 12 months afterwards to see how well it worked and if it’s safe.

Potential risks and benefits

Since this is a brand-new treatment, we don't know all the possible effects, and there might be risks we are not yet aware of. However, researchers are studying this treatment because it could potentially help improve or even resolve accidental bowel leakage, leading to a better quality of life. The known risks relate mostly to the procedures: taking the muscle sample and the injection itself could cause some pain, bruising, or a small risk of infection. You might also experience temporary discomfort, or rarely, other issues like bleeding or a reaction. Your safety will be closely watched throughout the trial, and you can stop participating at any time if you wish. You will receive a safety card with contact details if you have any questions or concerns.

Locations (2)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Barts Health NHS Trust
City only
London, England
University Hospital of Wales
City only
Cardiff, England

Common questions

What is accidental bowel leakage?

It's when you can't control your bowels, leading to unplanned leaks of stool (poo). It can range from small smears to a complete loss of bowel control.

Why is this study only for women?

This study focuses on women whose bowel leakage was caused by muscle damage during childbirth, as this is a specific group that needs new treatment options.

Will I know if I'm getting the real treatment?

Yes, in this particular study, all participants will receive the active cell treatment. There is no 'dummy' treatment.

What happens if I get pregnant during the study?

Because the treatment could have unknown risks for pregnancy, you will be withdrawn from the study if you become pregnant. Effective contraception is required for participants who could become pregnant.

Who is paying for this study?

The study is funded by Horizon 2020, which is a research and innovation program from the European Union.

How to find out more

Josephine Parker

cctu.amelie@ucl.ac.uk +44 (0)207 670 4845 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.