Multicentre, randomised, double-blind, Phase IIb study to evaluate the safety and efficacy of intralesional administration of two doses of expanded adipose tissue allogeneic adult mesenchymal stem cells (AdMSCs ), conditioned in hyaluronic acid hydrogel, as a treatment for patients with faecal incontinence.
This research is looking into a new way to treat faecal incontinence, which is when you have trouble controlling your bowels. The treatment involves injecting special cells taken from body fat, which are then prepared in a gel. Two different doses of these cells (called ALOFEC-60 and ALOFEC-120) are being tested to see how safe they are and how well they work. Researchers will follow participants for 12 months, checking for any side effects and seeing if symptoms of incontinence improve. They will measure changes in how often accidental bowel movements happen, how severe they are, and how much they affect a person's quality of life.
At a glance
What is this study about?
This study is testing a new treatment for people who experience faecal incontinence, which is the accidental leaking of stool. This can be a very challenging condition, impacting daily life and well-being. Researchers are hoping to find a new and effective way to help people regain better bowel control.
The treatment being tested uses special cells, called mesenchymal stem cells, which are taken from donate d body fat. These cells are then prepared in a gel and injected into the area that helps with bowel control. The idea is that these cells might help repair or strengthen the weakened tissues. The study is comparing two different doses of these cells, labelled ALOFEC-60 and ALOFEC-120, to see which might be safer and more effective.
The main goals of this study are to find out if this new treatment is safe and if it can reduce the severity and frequency of faecal incontinence. Researchers will carefully monitor participants for any side effects over 12 months. They will also use various methods to assess whether people's symptoms improve, such as tracking how often accidental bowel movements occur and how much the condition affects their quality of life.
Key takeaways
- This study is testing a new cell-based treatment for faecal incontinence.
- It uses cells taken from body fat, prepared in a gel.
- Two different doses of the treatment are being compared.
- The main goals are to check safety and see if bowel control improves.
- You would be followed for 12 months and have regular assessments.
Who may be eligible?
This study is open to both men and women who are at least 18 years old. If you have been diagnosed with faecal incontinence and are interested in exploring new treatment options, you might be a good fit.
There might be other specific health conditions or medications that could prevent someone from joining the study, but these details would be discussed with you by the study team.
It's important to have an open conversation with the study doctors to make sure this trial is right for your individual health situation.
- Are you at least 18 years old?
- Do you have problems with faecal incontinence?
- Are you able to attend regular appointments for 12 months?
- Are you open to trying a new, experimental treatment?
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 tracked for 12 months after receiving the treatment. You'll have regular hospital visits for check-ups and assessments. These visits will involve discussions about your health, any changes in your bowel control, and any side effects you might be experiencing. You'll also be asked to keep a diary of your bowel movements. There will be specific tests, like the "Jorge-Wexner test" to score your incontinence levels, and sometimes a test called "anal manometry" which measures the pressure in your anal muscles using a small probe. This helps understand how your muscles are working before and after the treatment. You'll also fill out questionnaires about how faecal incontinence affects your quality of life. The total duration of your active participation will be about 12 months, with follow-up appointments scheduled at different times during this period.
Potential risks and benefits
Locations (1)
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Common questions
What is faecal incontinence?
It's when you have accidental leakage of stool (bowel movements) and can't control when you pass them.
What are 'cells from body fat'?
These are special cells, called mesenchymal stem cells, taken from fatty tissue. They are thought to help repair and regenerate damaged tissues.
What do ALOFEC-60 and ALOFEC-120 mean?
These are the names given to the two different doses of the cell treatment being tested in the study.
What is the 'Jorge-Wexner test'?
It's a simple scoring system that helps doctors measure how severe your faecal incontinence is, from 0 (perfect control) to 20 (most severe).
How long will I be in the study?
You will be followed closely for 12 months after receiving the treatment to check on your progress and any side effects.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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