Trial status: active not recruiting
Trial ID: NCT06823713
What is the EMERALD study?
EMERALD is a clinical trial designed to test if a new treatment called RTX001 is safe, easy to cope with, and works well for people suffering from decompensated liver cirrhosis. The acronym spells “Evaluating Macrophages Engineered to Resolve Advanced Liver Disease”.
7 hospitals across England and Scotland are now taking part in the trial. The trial is sponsored by a company called Resolution Therapeutics Ltd.
What is the study drug being tested?
RTX001 is a novel treatment made by converting a small volume of a person’s own white blood cells into a different type of cell called macrophages. Macrophages are naturally occurring cells from our immune system and play an important role in eliminating disease and damaged cells. The process of modifying a cell is known as ‘cell-engineering’ and is carried out in a specialist laboratory. RTX001 is also an autologous product which means it can only be given to the person from whom the blood cells were collected.
How can engineered macrophages help to treat liver cirrhosis?
Scientific studies have shown that macrophages could play a helpful role by reducing inflammation in the liver and helping the liver to heal itself. This is because macrophages play a part in removing liver damaged tissue and scars, stopping new scars from forming, and stimulating the regeneration of the liver. To boost these properties, researchers at Resolution Therapeutics have engineered the macrophages in a laboratory with the goal of giving them a stronger and longer-acting benefit for patients.
How are the white blood cells collected?
To produce RTX001, participants will first begin treatment with a medicine called filgrastim. This is an injection that will help increase the number of white blood cells. Participants have up to five daily injections, some of which may be taken at home. Following the last injection, the white blood cells will be collected through a vein using a process called leukapheresis. Leukapheresis is a procedure in which white blood cells are separated from the collected blood using a specific machine. A sample of these white blood cells will then be used to make RTX001.
How is RTX001 treatment administered?
RTX001 is administered through a tube into a vein in an arm (this is called intravenous infusion). This takes about 30 minutes. Participants will receive up to 4 doses over the course of the study. One week after each dose, participants will have a visit at the hospital, and then a telephone call a week after that, to check for any side effects or any other problems.
