Treatment of refractory Crohn's disease lesions by local injection of mesenchymal stem cells
This research is looking into a new way to treat Crohn's disease, specifically for parts of the bowel that haven't healed with standard treatments. It involves injecting special 'mesenchymal stem cells' (MSCs) directly into these problem areas. The main goals are to see if these injections can help heal the affected parts of the bowel within 12 weeks and to make sure the treatment is safe. Researchers will closely monitor participants for any side effects and check their overall health. They will also look at how patients feel, their symptoms, and their quality of life over 48 weeks to understand the full impact of this new approach.
En un coup d'œil
De quoi parle cette étude ?
Crohn's disease is a long-term condition where parts of your digestive system become inflamed. This can cause pain, diarrhoea, and other uncomfortable symptoms. Sometimes, certain areas of the bowel don't heal well even with regular treatments. This study is exploring a new approach for these difficult-to-treat areas using 'mesenchymal stem cells' (MSCs). These are special cells that have the potential to help repair damaged tissues and calm inflammation.
In this study, doctors will carefully inject these MSCs directly into the part of the bowel affected by Crohn's disease that hasn't responded to other treatments. The main purpose is to see if this direct injection of MSCs can help these areas heal. They will be looking to see if the healing is complete or partial after 12 weeks. Researchers will also be checking the safety of this new treatment very closely.
Over nearly a year, the study team will track participants' well-being, symptoms like pain and how often they go to the toilet, and their general quality of life. They will also use scans like MRI to see if ulcers or narrowed parts of the bowel improve. By doing this, they hope to understand if this new treatment could be a safe and effective option for people living with Crohn's disease whose current treatments aren't fully working.
Points clés
- It's about a new cell-based treatment for Crohn's disease.
- Specifically targets areas not healing with current treatments.
- Main goals: healing and safety over 12 weeks.
- Follows participants for almost a year.
- Aims to improve symptoms and quality of life.
- Involves direct injections and regular check-ups.
Qui peut être éligible ?
To be considered for this study, you must be an adult aged 18 or over. This study is open to both men and women.
The study is specifically for people who have Crohn's disease that hasn't fully healed in certain areas of the bowel, despite receiving other treatments. The medical team would need to confirm that your specific condition meets the detailed requirements for the study.
It's important to note that joining a study like this usually means you can't be taking certain other medications or have other medical conditions that might interfere with the research or the safety of the new treatment. The study doctors will carefully check all health details.
Cet étude pourrait-elle vous convenir ?
Répondez à ces questions rapides pour voir si vous êtes éligible. Ceci est un guide uniquement — l'équipe de recherche prend la décision finale.
- Avez-vous 18 ans ou plus ?
- Do you have Crohn's disease?
- Do you have parts of your bowel affected by Crohn's that haven't fully healed with your current treatments?
- Are you able to attend regular follow-up appointments for almost a year?
En quoi consiste la participation ?
If you decide to take part, you would receive the special cell injection directly into the affected area of your bowel. On the day of your treatment, the doctors will check your vital signs (like heart rate and blood pressure) very carefully.
After the treatment, you would have several follow-up visits over a period of 48 weeks (about 11 months). During these visits, the study team will continue to monitor your vital signs and look for any side effects, both serious and minor. They will also ask you about your symptoms, pain levels, and how many times you go to the toilet each day, as well as your general well-being and quality of life. You may also have MRI scans at 12 and 48 weeks to check for healing in your bowel. You will be asked questions about your health and any issues you experience throughout this period, especially at weeks 0, 4, 12, 24, and 48.
Risques et avantages potentiels
Emplacements (1)
- —Non vérifiéBelgique
Questions fréquentes
What are mesenchymal stem cells (MSCs)?
MSCs are special cells that can help repair damaged tissues and reduce inflammation. In this study, they are being used as a potential new treatment for Crohn's disease.
Is this a new type of treatment?
Yes, this is an experimental treatment using MSCs directly injected into specific problem areas of the bowel. It's being tested to see if it's safe and effective.
How long will the study last if I join?
If you join, you would be followed for 48 weeks, which is just under a year, to see how you respond to the treatment and to monitor your health.
What kind of checks will I have during the study?
You'll have regular health checks, vital sign monitoring, symptom questionnaires, and possibly MRI scans to see how your bowel is healing.
Will I still take my regular Crohn's medication?
The study doctors will discuss all your current medications and how they fit with the study treatment. It's important to share all your medical information with them.
Comment en savoir plus
Parlez toujours à votre médecin généraliste ou spécialiste avant de décider de participer à une étude.
Intéressé à participer ?
Discussion
Discussion communautaire
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