Active not recruitingPHASE1, PHASE2INTERVENTIONAL

Evaluation of the Efficacy of Intramuscular Islet Autograft After Extensive Pancreatectomy

This study is looking at a new method for people who need a lot of their pancreas removed due to conditions like chronic pancreatitis. Normally, special cells called islets, which help control blood sugar, are put into the liver. However, this study is trying a new approach where these islets are put into muscle instead. The researchers believe that putting these cells into muscle might help them survive better and work more effectively to produce insulin. They hope this will lead to better blood sugar control and improve the health of people undergoing this type of surgery.

At a glance

Status

Active not recruiting

Phase

PHASE1, PHASE2

Sponsor

University Hospital, Lille

Enrolment target

Start

01 Mar 2013

Estimated completion

01 Apr 2026

Disorder of Endocrine Pancreas

What is this study about?

Imagine your pancreas as a factory that makes important hormones, including insulin, which helps your body use sugar for energy. Sometimes, due to illness like long-term inflammation (chronic pancreatitis) or certain growths, doctors need to remove a large part of your pancreas. When this happens, you can lose many of these insulin-making cells, called islets, which can lead to diabetes, where your body struggles to control blood sugar.

Currently, to try and prevent this, doctors can take these islets from the removed part of your pancreas and put them back into your body using a procedure called an islet autograft. Usually, these cells are put into your liver. However, scientists have found that the liver might not be the best place for these cells to survive long-term. Things like immediate reactions from your blood, poor blood supply to the new cells, and stress on the liver can impact how well these cells work.

This study is exploring a new idea: what if we put these important islet cells into a muscle instead? The researchers believe that muscle might be a more friendly and supportive environment for these cells. They hope this could help the cells get the blood supply they need, survive better, and more effectively produce insulin to help control your blood sugar after surgery. This new approach might also make it easier for doctors to check on the cells later on.

Key takeaways

Tests a new way to transplant insulin-making cells into muscle.
Aims to improve blood sugar control after major pancreas surgery.
For adults needing pancreas removal due to non-cancerous conditions.
Could offer a better environment for transplanted cells to survive.
Involves detailed follow-up appointments to monitor progress.

Who may be eligible?

This study is looking for adults aged 18 or older who need a significant part of their pancreas removed because of long-term inflammation (chronic pancreatitis), growths that aren't cancerous (like cysts or certain non-cancerous tumours), or injuries to the pancreas. Basically, if you have a condition of the pancreas that isn't due to genetics or cancer and requires major surgery, you might be able to take part.

However, you cannot join the study if doctors suspect your pancreatic problem is caused by genetics or is cancerous, either before, during, or after your surgery. Also, if you are pregnant, breastfeeding, or unable to give your full consent (for example, if you are under guardianship or in prison), you won't be able to participate. You also need to be part of a social security scheme, which helps cover healthcare costs.

Your medical team will carefully check all these points to see if this study is right for you, ensuring your safety and that the study results are as accurate as possible.

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 need a lot of your pancreas removed for a condition like chronic pancreatitis or a non-cancerous cyst?
Do your doctors believe your pancreas problem is not genetic or cancerous?
Are you NOT pregnant or breastfeeding?
Are you able to agree to take part in the study yourself?

Answer every question to see your result.

What does participation involve?

If you join this study, you will have your own pancreatic islet cells, which help control blood sugar, collected during your pancreas surgery. Instead of being put into your liver, these cells will be carefully placed into a muscle in your body, usually in your thigh. After the procedure, you will have regular check-ups with the study team to monitor your blood sugar levels and how well the transplanted cells are working. This will likely involve blood tests and possibly scans. The exact number and timing of visits will be explained to you in detail, but generally, studies like this involve close follow-up for several months to a few years to see the long-term effects. You won't be given any extra medication for this study beyond what your doctors prescribe for your usual care.

Potential risks and benefits

Potential benefits of taking part include the possibility that placing islet cells into muscle could help them survive and work better, potentially improving your blood sugar control or reducing your reliance on insulin injections after pancreas surgery. However, as this is a new method, it's not guaranteed to work better than the usual approach. Potential risks might include those common with any surgical procedure, as well as specific risks related to placing cells into muscle, such as discomfort or infection, though these are expected to be mild. The clinical team will discuss all known and potential risks with you in detail. Remember, your participation is completely voluntary, and you are free to withdraw from the study at any time without affecting your medical care.

Locations (4)

Chu Amiens Picardie
Verified postcode
Amiens, France
CHRU, Hôpital Claude Huriez
Verified postcode
Lille, France
Institut Paoli Calmettes
Verified postcode
Marseille, France
CHU Rouen
Verified postcode
Rouen, France

Common questions

What are 'islet cells'?

Islet cells are tiny groups of cells in your pancreas that produce hormones, like insulin, which help your body use sugar for energy.

Why put the cells in muscle instead of the liver?

Scientists think that muscle might be a better, more supportive place for these cells to live and work effectively than the liver, where they sometimes struggle.

Will this cure my diabetes?

This study aims to improve your body's ability to make insulin and control blood sugar after pancreas surgery, which could reduce diabetes symptoms, but it's not guaranteed to be a cure.

Is this a new medicine?

No, this is not a new medicine. It's a new way of using your own body's cells after surgery to help keep your blood sugar balanced.

How long will I be in the study?

The study involves collecting cells during your surgery and then having regular follow-up appointments for a period of time, which your doctors will explain in more detail.