European, multicentre, single arm (phase I) trial of autologous skeletal muscle derived cell (ASMDC) microcarrier combination for the treatment of faecal incontinence (FI) in women with obstetric anal sphincter injury.
This study is investigating a new treatment for women who experience accidental bowel leakage, also known as faecal incontinence. This can sometimes happen after childbirth if there is damage to the muscles that control the bowel. The new treatment involves using special cells taken from the woman's own muscles. These cells are then prepared in a specific way and put back into the damaged area to help repair it. This is a very early-stage study, called a Phase 1 trial. Its main purpose is to find out if this new treatment is safe for people. Doctors will also start to look at how well it works. This research is important for finding better ways to help women with this condition.
At a glance
What is this study about?
This research study is looking into a new way to help women who have problems controlling their bowels, which doctors call faecal incontinence. This condition can sometimes develop after women give birth, especially if the muscles around the back passage were stretched or torn during delivery.
The experimental treatment in this study uses what are called 'autologous skeletal muscle derived cells'. In simple terms, this means taking a small sample of muscle cells from a woman's own body. These cells are then carefully grown and prepared in a special way outside the body. After this, they are put back into the damaged muscle area near the back passage. The idea is that these cells might help to repair the damaged muscles and improve bowel control.
This is a 'Phase 1' study, which is the very first step in testing a new treatment in people. The main goal at this stage is to make sure the treatment is safe for women. Doctors will be watching very closely for any side effects. They will also collect early information on whether the treatment seems to be helping with bowel control. This kind of research is vital for developing new and potentially better treatments for conditions like faecal incontinence.
Key takeaways
- This study is for women with bowel leakage after childbirth.
- It tests a new treatment using your own muscle cells.
- It's a very early-stage 'safety' study (Phase I).
- Participation means having some procedures and regular check-ups.
- It may offer new hope but potential risks are unknown.
- You can stop participating at any time.
Who may be eligible?
This study is specifically designed for women aged 18 or older. It is for those who are experiencing accidental bowel leakage, also known as faecal incontinence, and whose condition is believed to be linked to damage to their anal sphincter muscles during childbirth.
There might be other health conditions or medications that would prevent someone from joining the study. These are put in place to ensure patient safety and to make sure the study results are as clear as possible. A doctor will be able to explain all the reasons why you might or might not be able to take part.
If you are a woman over 18 and have faecal incontinence that started after childbirth, and you are interested in learning more, you should speak to your doctor.
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 accidental bowel leakage (faecal incontinence)?
- Did your bowel leakage start after childbirth?
- Are you willing to attend multiple appointments for the study?
- Do you understand this is a new, investigational treatment?
What does participation involve?
If you decide to take part in this study, you would first have a number of appointments for health checks and tests to make sure the study is right for you. If you are eligible, you would then have a small procedure to take a tiny piece of muscle from your body. These cells would then be sent to a special lab to be prepared for the treatment.
Later, you would come back for the main treatment, where the prepared cells would be put into the affected area. After the procedure, you would have several follow-up visits over a period of time. These visits are important for the doctors to check your health, see how you are recovering, and understand if the treatment is helping. They will involve various tests and assessments. The study will last for a certain amount of time, and you will be told the full schedule before you make any decisions.
Potential risks and benefits
Locations (4)
- —UnverifiedFrance
- —UnverifiedSpain
- —UnverifiedAustria
- —UnverifiedDenmark
Common questions
What is faecal incontinence?
It means accidentally leaking from your bowel, which can be upsetting and impact daily life.
What does 'autologous' mean in this study?
It means the cells used in the treatment come from your own body, not from a donor.
Is this a new treatment?
Yes, this is an early-stage study testing a new approach, so it's not yet a standard treatment.
What is a 'Phase I' study?
It's the first time a new treatment is given to people. The main goal is to check if it's safe.
Will I get the actual treatment or a dummy treatment?
In this specific study, everyone who takes part will receive the active treatment as it doesn't compare to a placebo.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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