RecruitingPHASE1, PHASE2INTERVENTIONAL

RTX001 Autologous Engineered Macrophages for Liver Cirrhosis

This study, called EMERALD, is exploring a new treatment, RTX001, for people with advanced liver disease, such as cirrhosis. This special treatment uses your own white blood cells, called macrophages, which are then specially prepared to help reduce inflammation and scarring in the liver. The main goal is to find out if RTX001 is safe when given to people for the first time, and if it could help improve liver function. Participants will have some of their blood cells collected, which are then used to make their own personalised RTX001 treatment. The researchers will then check its effects. This is a vital first step in seeing if this innovative cell therapy could become a future treatment option.

At a glance

Status

Recruiting

Phase

PHASE1, PHASE2

Sponsor

Resolution Therapeutics Limited

Enrolment target

Start

15 Oct 2024

Estimated completion

29 Nov 2028

End-stage Liver Disease (ESLD)Cirrhosis, Liver Cirrhosis, Decompensated Liver Diseases Fibrosis and Cirrhosis of Liver Decompensated Liver Cirrhosis Decompensated Cirrhosis Steatotic Liver Disease

What is this study about?

This study is investigating a new and innovative treatment named RTX001 for people who have severe liver conditions, especially liver cirrhosis. Cirrhosis is when your liver becomes permanently scarred, and this can stop it from working properly. RTX001 is a special type of cell therapy, meaning it uses living cells as a medicine.

What makes RTX001 unique is that it’s made from your very own cells. Specifically, it uses a type of white blood cell called a macrophage. These cells are taken from your blood and then specially prepared in a lab to give them properties that can help reduce inflammation and scarring in your liver – two key problems in cirrhosis. The main aim of this study is to see if this treatment is safe for people and if it might improve their liver health.

This is the very first time RTX001 will be given to human patients, which is why it's a careful and important step. The study will also compare the results with information from other patients with similar liver conditions to understand how well RTX001 is working.

Key takeaways

This is a study of a new experimental liver treatment, RTX001.
RTX001 uses your own white blood cells to target liver scarring and inflammation.
It's the first time this treatment will be tested in people.
The study aims to check if the treatment is safe and if it helps the liver.
Participation involves a special blood cell collection and follow-up appointments.

Who may be eligible?

To join this study, you need to be an adult between 18 and 75 years old. You must have a diagnosis of liver cirrhosis, which can be confirmed by various tests like scans or a liver biopsy. The cause of your liver disease should be related to conditions like fatty liver disease or alcohol-related liver disease. If it's alcohol-related, you must not be drinking alcohol above certain limits.

You also need to have recently experienced a significant worsening of your liver condition (called 'decompensation'), such as having fluid build-up in your tummy (ascites), or have ascites that keeps coming back and needs treatment regularly. There are specific measurements and criteria for these conditions, ensuring that the study enrols people who could potentially benefit most from this early-stage treatment.

Before you can take part, doctors will also check that you don't have any known reasons why you shouldn't receive the blood cell collection procedure (leukapheresis) or a specific medication called filgrastim, both of which are part of the treatment process.

Quick self-check

Are you between 18 and 75 years old?
Have you been diagnosed with liver cirrhosis?
Is your liver disease related to conditions like fatty liver disease or alcohol use?
Have you had a recent serious worsening of your liver condition (e.g., fluid in the tummy)?
Are you able to attend appointments for cell collection and follow-up?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part in this study, the first step will be to collect some of your white blood cells. This is done through a process called 'leukapheresis', which is similar to donating blood but specifically separates out your white blood cells using a special machine. These collected cells are then sent to a facility to be transformed into your personalised RTX001 treatment.

Once your RTX001 is ready, it will be given back to you. Because it's made from your own cells, it can only be used by you. After you receive the treatment, you will have several follow-up appointments. These visits are important for the doctors to carefully monitor your health, check for any side effects, and see how your liver is responding to the treatment. The study will track your progress over a period, comparing it to other patients to understand the treatment's safety and effectiveness.

Potential risks and benefits

Participating in this study might offer potential benefits, as RTX001 is designed to reduce inflammation and scarring in the liver and could potentially improve liver function. However, this is a very early-stage study, meaning the treatment is new and its full effects and potential side effects are not yet completely known. As with any medical procedure, there are potential risks involved in the blood cell collection process (leukapheresis) and with receiving the new cell therapy, which your doctor will discuss with you in detail. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (14)

Hospital Universitari Vall d'Hebron
Barcelona, Spain· Recruiting
Hospital Universitario Reina Sofía
Córdoba, Spain· Recruiting
Hospital General Universitario Gregorio Marañon
Madrid, Spain· Recruiting
Hospital Universitario Ramón y Cajal
Madrid, Spain· Recruiting
Hospital Universitario La Paz
Madrid, Spain· Recruiting
Hospital Universitario Virgen del Rocío
Seville, Spain· Recruiting
Bristol Royal Infirmary
Bristol, United Kingdom· Recruiting
Royal Infirmary of Edinburgh
Edinburgh, United Kingdom· Recruiting
Glasgow Royal Infirmary
Glasgow, United Kingdom· Recruiting
Royal Liverpool University Hospital
Liverpool, United Kingdom· Recruiting
King's College Hospital
London, United Kingdom· Recruiting
St George's Hospital
London, United Kingdom· Recruiting

+2 more sites — see the official record for the full list.

Common questions

What is RTX001?

RTX001 is a new treatment made from your own white blood cells, specially prepared to help reduce liver inflammation and scarring.

What is liver cirrhosis?

Liver cirrhosis is a serious condition where your liver is badly scarred, stopping it from working properly.

Is this treatment available to everyone?

No, this is a clinical trial, meaning it's only open to people who meet very specific health requirements.

Will I have to stay in hospital?

Some parts of the study may require hospital visits, including the cell collection process and treatment, but not necessarily a long stay.

What does 'autologous' mean?

'Autologous' means the treatment uses your own body's cells, so it's a personalised medicine just for you.

How to find out more

Resolution Therapeutics Clinical Enquiries

clinical.enquiries@resolution-tx.com +442037811105 Official trial record

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