AuthorisedPhase I and Phase II (Integrated)- Bioequivalence StudyInterventional

Cell-based immunotherapy in solid organ transplantation to minimize systemic immunosuppression

This research is looking at a new way to help people who have just had a liver transplant. After a transplant, patients usually need to take powerful medicines for the rest of their lives to stop their body from rejecting the new liver. This study is testing a special cell treatment, made from the organ donor's cells, to see if it can help the patient's body accept the new liver more naturally. The main goal is to find out if this cell treatment is safe and if it can eventually allow patients to take fewer or even no anti-rejection medicines, which can have many side effects. This could lead to a better quality of life for transplant patients.

At a glance

Status

Authorised

Phase

Phase I and Phase II (Integrated)- Bioequivalence Study

Sponsor

Karolinska University Hospital

Enrolment target

Start

17 Oct 2024

Patients with end-stage liver disease undergoing liver transplantation with deceased donor organ

What is this study about?

When someone receives a new liver, their body's immune system often sees the new organ as 'foreign' and tries to attack it. To prevent this, patients must take strong anti-rejection medicines, called immunosuppressants, every day. While these medicines are vital, they can have significant side effects like increasing the risk of infections, kidney problems, or even certain cancers.

This study is exploring a new approach using special cells from the organ donor. These cells, called Donor Specific Immunomodulatory Cells (or DSIMC for short), are given to the patient after their liver transplant. The idea is that these cells might help the patient's immune system learn to accept the new liver without needing such high doses of traditional anti-rejection medicines. Think of it like teaching the body to be friends with the new liver.

The main aim of this early-stage study is to make sure this new cell treatment is safe for patients in the first year after their transplant. Researchers will also be looking to see if, over a longer period (up to three years), patients treated with these cells can reduce or even stop taking their anti-rejection medicines while their new liver continues to work well. If successful, this could significantly improve the long-term health and well-being of liver transplant recipients.

Key takeaways

Tests a new cell treatment after liver transplant.
Aims to reduce the need for lifelong anti-rejection medicines.
Main focus is to ensure the new treatment is safe.
Could improve quality of life for transplant patients.
Involves regular check-ups and monitoring for three years.

Who may be eligible?

This study is for adults aged 18 years and above who are having a liver transplant. You would be considered for this study if you are receiving a new liver from a donor who has passed away, rather than a living donor.

The research team will carefully check other aspects of your health and your specific situation to make sure this study is the right fit for you. Not everyone who meets the age and transplant criteria will be able to join, as there are other important health factors that need to be considered for your safety.

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?
Are you having a liver transplant soon?
Is your new liver coming from a deceased donor?
Are you able to attend regular follow-up appointments?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will receive the special cell treatment after your liver transplant. The research team will closely monitor your health, your new liver's function, and any anti-rejection medicines you are taking. You will have regular check-ups and tests, such as blood tests, throughout the study. This close monitoring is especially important in the first year after your transplant to ensure the treatment is safe. The study will continue for up to three years, with ongoing assessments to see how your body is responding and if your need for anti-rejection medicines can be reduced.

Potential risks and benefits

The potential benefit of joining this study is that the new cell treatment might help you take fewer anti-rejection medicines in the future, which could lead to fewer side effects and a better quality of life. However, as with any new treatment, there are potential risks, and we don't yet know all of them. The study's main goal is to carefully check the safety of this new treatment. There might be side effects from the treatment, or it might not work as hoped. You are free to withdraw from the study at any time, for any reason, without it affecting your 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
Sweden

Common questions

What are 'anti-rejection medicines'?

These are powerful drugs you take after a transplant to stop your body's immune system from attacking your new liver.

What are the side effects of anti-rejection medicines?

They can increase your risk of infections, kidney problems, high blood pressure, and sometimes even certain cancers.

What are 'donor specific immunomodulatory cells'?

These are special cells taken from the liver donor that are given to you. We hope they'll help your body accept the new liver more easily.

How long will this study last for me?

You will be closely followed for three years after your liver transplant if you join the study.

Will I still need to take anti-rejection medicines if I join?

Yes, you will still take anti-rejection medicines, but the study hopes to see if you can reduce the amount you need over time.