RecruitingPHASE3INTERVENTIONAL

Skeletal Muscle-derived Cell Implantation for Treatment of Fecal Incontinence

This research is investigating a new treatment for fecal incontinence, a common condition where people accidentally leak stool. This often happens because the muscles controlling bowel movements in the bottom (called the anal sphincter) are damaged or weak. The study uses a special treatment made from the patient's own muscle cells, called autologous skeletal muscle-derived cells (aSMDC). These cells are put back into the anal sphincter to help it work better. This is a Phase 3 study, meaning it's in the final stages of testing to see if the treatment is safe and effective compared to a 'dummy' treatment (placebo). The goal is to improve accidental bowel leakage in people who haven't been helped enough by other treatments.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

Innovacell GmbH

Enrolment target

290

Start

11 May 2022

Estimated completion

31 Jul 2027

Fecal Incontinence

What is this study about?

Fecal incontinence, sometimes called accidental bowel leakage, is a condition where people struggle to control their bowel movements, leading to accidental leakage of stools. This can be very upsetting and impact daily life. Often, this happens because the muscles around the anus, particularly the external anal sphincter, are weak or damaged.

This study, called a Phase 3 trial, is looking at a new way to help these muscles recover. It uses a treatment made from your very own muscle cells. Doctors would take a small sample of your muscle, grow more of these special cells, and then carefully put them back into the weakened muscles around your anus. The idea is that these new cells will help to repair and strengthen the muscles, making it easier to control your bowel movements and reduce accidental leakage.

This trial is important because it's comparing this new cell treatment to a 'placebo,' which is an inactive treatment. This helps researchers understand whether the cell treatment is truly effective and safe. If successful, this could offer a new option for people with fecal incontinence who haven't found enough relief from standard treatments.

Key takeaways

This study is testing a new treatment for accidental bowel leakage (fecal incontinence).
It uses your own muscle cells to strengthen the anal sphincter muscles.
The treatment is compared to a placebo to see if it's effective and safe.
You must have had symptoms for at least 6 months, and other treatments haven't helped enough.
Participation involves clinic visits and procedures to collect and inject the cells.
You can withdraw from the study at any time.

Who may be eligible?

To join this study, you need to be at least 18 years old and understand what the study involves. If you're a woman who could become pregnant, you'll need to use reliable birth control. You must have had accidental bowel leakage (fecal incontinence) for at least six months, and usual treatments (like diet changes or exercises) haven't helped enough for at least three months. You should be experiencing leakage more than twice a week, and your anal muscle strength needs to be within a certain range as measured by a special test.

However, this study might not be right for you if your accidental bowel leakage is caused by something other than a problem with your anal sphincter muscle. You also can't join if you've had recent surgery in the bottom area (within the last 6 months) or multiple previous surgeries on your anal sphincter. People with current or recurring anal infections or tears, severe constipation, or certain serious health conditions like cancer not in remission, a weakened immune system, or inflammatory bowel disease (like Crohn's or colitis) are also unable to take part.

Quick self-check

Are you 18 years old or older?
Have you had accidental bowel leakage more than twice a week for at least 6 months, and other treatments haven't helped much?
Do you feel your accidental bowel leakage is due to problems with your anal muscles rather than other causes?
Have you NOT had surgery in your bottom area in the last 6 months, or multiple surgeries on your anal muscles before?
Do you NOT currently have serious anal infections, severe constipation, or certain long-term illnesses like inflammatory bowel disease or recent cancer?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you join this study, you'll be assigned to either receive the new cell treatment or a 'dummy' treatment (placebo). Neither you nor your doctor will know which one you receive until after the study is complete. This helps to ensure the results are accurate. You will have several visits to the clinic for assessments, including physical exams, questionnaires about your symptoms, and possibly some special tests like anal manometry (to measure muscle strength) and ultrasound (to look at the muscle structure).

The cell treatment itself involves a minor procedure to collect a small muscle sample, and then another procedure to inject the prepared cells (or placebo) into the anal sphincter. You’ll have follow-up appointments over a period of time to see how you're feeling and how the treatment is working. The total duration of your participation in the study will be explained by the study team.

Potential risks and benefits

Taking part in any study has potential benefits and risks. You might benefit if the cell treatment helps improve your fecal incontinence symptoms, potentially leading to better control and quality of life. However, like any medical procedure, there's a chance of side effects or complications from the muscle sample collection or the injection, such as pain, bruising, or infection. The study team will explain all known risks to you. Remember, you can choose to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (31)

Landeskrankenhaus Feldkirch
Feldkirch, Austria· Recruiting
Medical University Graz
Graz, Austria· Recruiting
Medical Center Unimed EOOD
Sevlievo, Bulgaria· Recruiting
Fakultni nem. u sv. Anny v Brne
Brno, Czechia· Recruiting
The Institute for the Care of Mother and Child
Prague, Czechia· Recruiting
Deaconess Hospital Group Croix Saint - Simon
Paris, France· Recruiting
Hospital Bichat - Claude Bernard
Paris, France· Recruiting
CHU Rennes - Hospital Pontchaillou
Rennes, France· Recruiting
CHU de Rouen
Rouen, France· Recruiting
Heidelberg University, Medical Faculty Mannheim, Department of surgery
Mannheim, Germany· Recruiting
IRCCS Ospedale San Raffaele
San Donato Milanese, Italy· Recruiting
Hokkaido Railway Company JR Sapporo Hospital
Sapporo, Japan· Recruiting

+19 more sites — see the official record for the full list.

Common questions

What is fecal incontinence?

Fecal incontinence is the accidental leakage of bowel movements, ranging from occasional smudging to complete loss of bowel control. It's often caused by weakened or damaged muscles that control the anus.

What is a 'placebo'?

A placebo is a 'dummy' treatment that looks just like the real treatment but doesn't contain any active medicine. It helps researchers fairly compare the new treatment's effects.

Will I know if I'm getting the active treatment or a placebo?

No, neither you nor your doctors will know if you are receiving the active cell treatment or the placebo until the study is finished. This is standard practice in clinical trials to ensure unbiased results.

What are autologous skeletal muscle-derived cells?

These are special muscle cells taken from your own body. They are grown in a lab and then used in the treatment to help repair and strengthen your weakened anal sphincter muscles.

What does a 'Phase 3' study mean?

A Phase 3 study is one of the final stages of clinical research. It involves a larger number of patients and aims to confirm the treatment's effectiveness, monitor side effects, and compare it to existing treatments or a placebo.

How to find out more

Innovacell

office@innovacell.com +43512573680 Official trial record

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