RecruitingPhase I/IIInterventional

Treatment of acute liver failure in children with liver cells and support cells suspended in a gel

This study is testing a new way to help children with acute liver failure, a very serious condition where the liver suddenly stops working. Often, a liver transplant is needed, but donor livers are scarce. This research uses healthy liver cells and support cells from donors, enclosed in a special seaweed jelly, and gently placed into the child's tummy. The idea is that these cells can do some of the liver's work, giving the child's own liver a chance to heal or bridging the time until a transplant. This treatment is less invasive than a full transplant and may avoid the need for strong anti-rejection medicines. The main goals are to check if the treatment is safe, if the body tolerates it well, and if it helps the children.

At a glance

Status

Recruiting

Phase

Phase I/II

Sponsor

King's College Hospital NHS Foundation Trust

Enrolment target

Start

01 Jun 2025

Estimated completion

01 Sep 2027

Hepatocyte transplantation in paediatric acute liver failure

What is this study about?

When children get acute liver failure, their liver suddenly stops working properly. This is a very serious condition, and sadly, many children need a liver transplant to survive. However, there aren't always enough donor livers available, and a transplant is a big operation that requires strong medicines for life to stop the body rejecting the new liver.

This study is exploring a new, gentler approach. It uses healthy liver cells from donor livers that can't be used for a full transplant. These cells, along with some helpful support cells, are carefully placed inside tiny beads made from a seaweed-based gel. These beads are then gently put into the child's tummy. The hope is that these tiny cell beads can act like a temporary mini-liver, performing vital jobs like cleaning the blood and making important substances. This could give the child's own liver time to recover and heal itself, or it could keep them stable until a suitable donor liver becomes available for a full transplant.

Because the cells are protected within the special gel, the body might not see them as foreign, potentially reducing the need for strong medicines that suppress the immune system. This research is a Phase I/II study, which means the main focus is to check if this new treatment is safe for children and if their bodies tolerate it well. We also want to see if the cells show signs of helping the liver function. If successful, this could be a really important step forward for children with acute liver failure.

Key takeaways

A new treatment for children with sudden liver failure is being tested.
It uses donor liver cells and support cells in a special gel.
The goal is to help the child's own liver recover or bridge to a transplant.
This method might be less invasive and avoid strong anti-rejection drugs.
The study mainly checks the safety and how well the body tolerates the treatment.
Participation involves careful monitoring and long-term follow-up.

Who may be eligible?

This study is looking for babies and children under 16 years old who have acute liver failure. This means their liver has suddenly stopped working well, and they don't have a known long-term liver problem.

However, some conditions might mean a child cannot take part. For example, if they have severe swelling in their tummy (ascites), an infection in their tummy, or if they are too unwell for the procedure. Children who are pregnant or breastfeeding, or who have had a liver transplant previously, are also not able to join. There are also specific rules about certain allergies, such as to alginate (the gel material) or gentamicin (an antibiotic).

Also, if a child is expected to have a full liver transplant within 12 hours, or is on certain life support machines, or has significant scarring in their tummy that could make the procedure difficult, they wouldn't be able to participate. The study also cannot include children who weigh more than about 33kg.

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.

Is my child under 16 years old?
Does my child have acute liver failure (sudden liver failure)?
Does my child meet the weight requirements (not over 33kg)?
Is my child not currently pregnant or breastfeeding?
Does my child not have severe tummy swelling, tummy infection, or certain allergies (alginate, gentamicin)?
Is my child not expected to have a full liver transplant very soon (within 12 hours)?

Answer every question to see your result.

What does participation involve?

If a child joins this study, they will first have several checks while being cared for in a special ward (like a high dependency or intensive care unit), as this level of care is normal for children with serious liver problems. Once everything is ready, the special cell treatment, which comes in a liquid with tiny beads, will be gently put into the child’s tummy. This is done using a special ultrasound machine to guide it, and it might be given in one go or in smaller amounts depending on the child's weight.

After the treatment, the child will continue to be closely watched, especially for at least 24 hours, in the high dependency or intensive care unit. Once they are stable, they will move to a regular children's ward. They will have daily check-ups for about a week. After leaving the hospital, they will have follow-up appointments at 2, 4, 8, 12, 16, 24, and 52 weeks. The child will finish the study if they have a liver transplant or if their own liver recovers fully. They will also be followed up, at least once a year, for an additional 9 years to check for any long-term effects, alongside their usual medical care. The entire study, including this long-term follow-up, is expected to run until September 2037.

Potential risks and benefits

It's important to know that we are still learning about this new treatment, so we don't yet know for certain how much it will help. While early results from similar treatments have been promising, we hope this study will show if it can act as a temporary help until a transplant, or even be an alternative for children who can't have a transplant. As with any medical procedure, there are possible risks. These could include a fever, an allergic reaction, temporary pressure in the tummy, bleeding, or infection where the treatment is given. The medical team will be watching closely for any of these issues in the intensive care unit and will provide immediate care if needed. You are always free to discuss stopping your child's participation in the study at any time, and this will not affect their usual medical care.

Locations (1)

Kings College Hospital
Approximate
London, United Kingdom

Common questions

What is acute liver failure?

It's a serious condition where the liver suddenly stops working properly in a child who did not have a long-term liver illness before.

What are 'hepatocytes' and 'mesenchymal stromal cells'?

Hepatocytes are healthy liver cells, and mesenchymal stromal cells are special support cells. They both come from donor livers and are thought to help the liver work and heal.

What is 'alginate microbeads'?

These are tiny beads, made from a gel found in seaweed, that hold the cells. They help protect the cells when they are placed in the child's body.

Will my child need strong anti-rejection drugs?

One of the hopes for this treatment is that the gel protecting the cells will mean anti-rejection drugs might not be needed, unlike with a full organ transplant.

How long will my child be in the study?

Your child will be closely monitored for about a week in hospital, and then followed up regularly for a year. There will also be yearly check-ups for safety for up to 9 years after the treatment.

How to find out more

Anil Dhawan

anil.dhawan@kcl.ac.uk +44 (0)203 2994408 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.