Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

A phase II, national, multicenter, uncontrolled and open trial to evaluate the feasibility and safety of lamparoscopic administration of allogenic mesenchymals stem cell (adMSC) extracted by lipoaspirate from healthy patients, for the treatment of patients with inflammatory bowel strictures associated with Crohn's disease. SM

This study, called a Phase II trial, is looking at a new way to treat strictures in patients with Crohn's disease. Strictures are narrowings in the gut that can cause pain and blockages. The treatment involves using special cells, called mesenchymal stem cells, taken from the body fat of healthy donors. These cells are given to patients using a keyhole surgery method. The main goal of the study is to check how safe this treatment is and to keep an eye on any side effects or problems that might happen during or after the procedure. Researchers also want to see if the treatment can help reduce the strictures, improve patients' symptoms, and boost their quality of life. Participants will be monitored for a significant period to understand the long-term effects.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Instituto De Investigacion Sanitaria Fundacion Jimenez Diaz

Enrolment target

Start

28 Jul 2023

Crohn's disease

What is this study about?

This study is a research project focusing on a common complication of Crohn's disease called strictures. Strictures are areas where the bowel becomes narrow, making it difficult for food to pass through and causing symptoms like pain, bloating, and vomiting. Currently, strictures often require surgery or other procedures to widen them, but this study is exploring a new approach.

The trial is investigating a treatment that uses special cells called 'mesenchymal stem cells.' These cells are taken from the body fat of healthy volunteers. The idea is that these cells may have properties that can help reduce inflammation and promote healing in the bowel, potentially easing the strictures. The treatment involves a type of keyhole surgery to carefully place these cells where they are needed.

This is a 'Phase II' study, which means it's one of the earlier stages of testing a new treatment in humans. At this stage, doctors are mainly focused on understanding if the treatment is safe and if it causes any noticeable side effects. They will also be looking closely to see if there are any signs that the treatment might be effective in helping people with Crohn's disease strictures, with the hope that it could offer a new option for patients in the future.

Key takeaways

This study is testing a new cell-based treatment for Crohn's strictures.
The treatment uses special cells from healthy donors, given via keyhole surgery.
The main aim is to check the treatment's safety and look for side effects.
Researchers will also track if the treatment helps improve symptoms and stricture size.
Participation involves a procedure and regular check-ups over about a year.

Who may be eligible?

To join this study, generally, you need to be an adult, aged 18 years or older. Both men and women are welcome to take part. The study is specifically for people who have Crohn's disease and have also developed strictures, which are narrowings in their bowel.

There might be other specific health conditions or medications that would mean you couldn't join. For example, if you have other serious health problems, are pregnant, or are taking certain medicines, you might not be suitable. This is to ensure your safety and that the study results are clear.

It's important to have a full discussion with your doctor to understand all the specific requirements for joining. They can check your medical history to see if this study is the right fit 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 18 years old or older?
Do you have a diagnosis of Crohn's disease?
Do you have strictures (narrowings) in your bowel due to Crohn's?
Are you able to attend appointments and follow-ups for over a year?
Are you willing to have a keyhole surgery procedure?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would undergo a procedure where special cells are administered using a keyhole surgery method. This will involve an anaesthetic, so you would be asleep during the procedure. After the treatment, you would have several clinic visits over a period of about a year (52 weeks).

During these visits, doctors will monitor your health closely, check for any side effects, and see how your strictures are responding. This will involve physical examinations, discussions about your symptoms (using special questionnaires like the CDAI and IBDQ32, which ask about your Crohn's disease and quality of life), and possibly some imaging scans to look at your bowel. They will also keep track of whether you have any bowel blockages or need surgery during the study. The total duration of your active participation, with regular check-ups, would be just over one year.

Potential risks and benefits

Taking part in a study like this could offer potential benefits, as it might provide a new way to treat your strictures that isn't currently available. However, there's no guarantee the treatment will work for you, and it's also possible it might not make a difference. As with any medical procedure, there are potential risks, including those related to the anaesthetic used during the keyhole surgery, and any side effects or complications from the treatment itself. These will be carefully monitored. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

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

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Unverified
Spain

Common questions

What are strictures in Crohn's disease?

Strictures are narrowings or blockages that can develop in your bowel due to inflammation caused by Crohn's disease. They can make it hard for food to pass through.

Where do the special cells come from?

The special cells used in this study, called mesenchymal stem cells, are taken from the body fat of healthy people who have donated them.

What does a 'Phase II' study mean?

A Phase II study means researchers are mainly checking if a new treatment is safe and if there are any early signs that it might be helpful for a specific condition. It's an important step in developing new medicines.

Will I need surgery if I join this study?

The treatment itself is given through a keyhole surgery procedure. The study will also track if you need any additional surgery for strictures during the study period.

How long will I be involved in the study?

If you join, you'll be monitored for just over a year, with several check-up appointments to see how you're doing after the treatment.