A single-site study to understand the best route of delivery for a new cell-based treatment created from patient's own white blood cells for rheumatoid arthritis
Rheumatoid arthritis is a long-term condition where the body's immune system mistakenly attacks healthy joints, causing pain and swelling. Researchers at Newcastle University are testing an experimental cell therapy created from a person's own white blood cells. These cells are specially treated in a laboratory to help calm down the faulty immune response. An earlier study showed that this approach was safe when injected into a knee joint. This new study will explore whether other injection routes work better. Doctors will compare giving the cells into a knee, under the skin of the thigh, or directly into a lymph node (a small gland that helps manage the immune system). A total of 20 adults with rheumatoid arthritis will take part. Most will receive the cell therapy alongside their standard medications, while others will stay on standard care alone to allow a direct comparison.
At a glance
What is this study about?
Rheumatoid arthritis occurs when the immune system, which normally fights off infections, turns on the body's own joint linings. Current treatments usually involve medicines that dampen the immune system broadly. In this study, scientists are exploring a more targeted approach using 'tolerogenic dendritic cells'. These are special white blood cells taken from the patient and trained in a laboratory to encourage the immune system to tolerate the joints rather than attack them.
In a previous trial called AuToDeCRA, doctors proved it was possible to create these personalised cells and inject them safely into arthritic knees. However, scientists believe the cells might work more effectively if they travel directly to lymph nodes, which are small immune glands found throughout the body. The AuToDeCRA-2 trial will compare three different ways of giving the treatment: an injection into the knee, into the skin of the upper thigh, or straight into a lymph node.
Because this is an early-stage study, the main goal is to see how the immune system responds to each route and whether smaller doses can be used when injecting directly into a gland. This work will help researchers understand if personalised cell therapy could become a helpful future treatment option for people living with inflammatory joint disease.
Key takeaways
- Tests a personalised treatment made from your own white blood cells.
- Compares three injection routes: into a knee, thigh skin, or a lymph node.
- Involves 20 adults with rheumatoid arthritis followed over 25 weeks.
- Participants continue their usual care, with most receiving the new cell therapy.
- The trial takes place at Newcastle University and is funded by Versus Arthritis.
Who may be eligible?
This trial is open to adults aged 18 and over who have been diagnosed with rheumatoid arthritis for between 4 months and 10 years. Participants need to have a specific antibody in their blood linked to rheumatoid arthritis (called ACPA) and carry a particular tissue type, which can be checked by the study team with a blood test.
Your current arthritis medications must have been at a steady dose for at least four weeks before joining. Many common treatments, such as methotrexate, sulfasalazine, and biologic therapies, are permitted as long as your condition is reasonably stable.
You cannot join the trial if you have recently taken steroid tablets or had steroid injections within the last four weeks, or if you take medicines known as JAK inhibitors or leflunomide. People with active infections, serious heart or lung conditions, a history of cancer, or those planning to receive live vaccines will also not be able to take part.
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.
- I am an adult aged 18 or over.
- I have had rheumatoid arthritis diagnosed between 4 months and 10 years ago.
- My arthritis medications have been at a stable dose for at least 4 weeks.
- I have not had steroid tablets or steroid injections in the past 4 weeks.
- I do not have an active infection or any severe heart, lung, or kidney conditions.
What does participation involve?
Taking part lasts up to 25 weeks and involves around 7 to 8 hospital visits in Newcastle. Out of 20 participants, 16 will receive the cell therapy alongside their regular treatment, while 4 will continue with their standard NHS care alone. If you are selected to receive the cell therapy, you will first undergo a routine procedure called leukapheresis. During this visit, blood is taken from a vein in your arm, passed through a machine that gently collects the needed white blood cells, and the remaining blood is returned to you. The cells are then prepared in a specialised laboratory. Later, you will receive your injection into a knee, the thigh skin, or a lymph node (guided safely by an ultrasound scan). Throughout the 25 weeks, doctors will monitor your joint symptoms and take blood and tissue samples to check your safety. You will also have access to a 24-hour contact number if you experience any symptoms between visits.
Potential risks and benefits
Locations (1)
- Royal Victoria InfirmaryApproximateNewcastle upon Tyne, England
Common questions
What is the new treatment made from?
It is made from your own white blood cells. These are collected from your blood and trained in a laboratory to help settle down the immune system before being given back to you.
Will I have to stop taking my usual arthritis medication?
Most people continue taking their standard arthritis medicines at a stable dose throughout the trial. However, certain drugs like steroid tablets or JAK inhibitors cannot be taken during the study.
What is leukapheresis?
It is a standard hospital procedure where blood is drawn through a small tube in your arm, passed through a filtering machine to collect specific white blood cells, and returned safely to your body.
Will this treatment cure my rheumatoid arthritis?
No, this study is not expected to cure arthritis. It is an early-stage test to find the safest way to deliver the treatment and to see how the immune system responds.
Where does the study take place?
The study takes place at a single hospital site in Newcastle upon Tyne, UK, and is run by researchers from Newcastle University.
How to find out more
Ema-Louise Long
Always speak to your GP or specialist before deciding to take part in a study.
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