Active not recruitingNAINTERVENTIONAL

The Effect of Low-dose Interleukin-2 on the Immune Landscape of Human Atherosclerotic Plaques at Single Cell Resolution.

This research looks into how a low dose of a natural body substance, Interleukin-2 (IL-2), influences the immune system within fatty plaques in the neck arteries. These plaques can cause serious conditions like mini-strokes (TIAs). Participants are people already scheduled for surgery (carotid endarterectomy) to remove these plaques. Scientists are using advanced techniques to examine changes in specific immune cells (Treg cells) within the plaques. The aim is to discover if IL-2 can make these cells more active in calming inflammation, potentially leading to better patient outcomes. This study helps us understand the disease better and could lead to new ways to treat it.

At a glance

Status

Active not recruiting

Phase

Sponsor

Cambridge University Hospitals NHS Foundation Trust

Enrolment target

Start

26 Aug 2023

Estimated completion

01 Sep 2025

TIA Carotid Artery Plaque Carotid Atherosclerosis

What is this study about?

This study is exploring a new way to understand and potentially treat problems caused by fatty build-ups, called plaques, in the arteries in your neck. These plaques can lead to serious health issues, such as a mini-stroke (TIA) or a full stroke. The study focuses on how a medication, Interleukin-2 (IL-2), affects certain immune cells, called Treg cells, found within these plaques. We know that inflammation plays a big role in how these plaques develop and cause problems, and Treg cells are important for controlling inflammation.

Up until now, it has been difficult to get a really close look at what's going on inside these plaques at a cellular level. However, new advanced technologies allow us to examine individual cells within the plaque in much greater detail. This means we can now see how different cells behave and interact, giving us a much clearer picture of the disease process. This study is using these powerful new tools to see if giving a low dose of IL-2 can make the Treg cells in the plaque more active in calming inflammation.

The main goals are to see if IL-2 can change the Treg cells in the plaque to be more 'protective' and less inflammatory, to then check if this change leads to the whole plaque becoming less inflammatory, and finally, to understand how these changes in the plaque relate to other immune cells circulating in your blood. Essentially, this research hopes to find new insights that could one day lead to better medicines for people with these conditions, by targeting the immune system to reduce inflammation in the plaques.

Key takeaways

Investigating how IL-2 affects immune cells in neck artery plaques.
Aimed at understanding and reducing inflammation in these plaques.
Uses advanced techniques to study cells in great detail.
Participants are those already having routine plaque removal surgery (carotid endarterectomy).
May lead to new ways to treat conditions like mini-strokes (TIA).
Participation helps advance medical knowledge for future patients.

Who may be eligible?

This study is looking for volunteers who have a narrowed neck artery (carotid stenosis), which has been confirmed by a scan, and who are already scheduled to have surgery to remove this plaque (a procedure called carotid endarterectomy). This surgery is a standard treatment for their condition.

There are certain health conditions or situations that would prevent someone from taking part. For instance, people with autoimmune diseases, those who are already on regular strong immune-suppressing medications (though some mild steroid use like inhalers is okay), or individuals with significant liver or kidney problems cannot join. Also, if you have a current active infection, a history of certain viral infections like HIV or hepatitis, or are undergoing treatment for cancer, you would not be able to participate. It's also not suitable for pregnant or breastfeeding women, or women who could become pregnant during the study period.

The research team will carefully review your medical history and current health to make sure that taking part in the study is safe and appropriate for you. They will explain everything clearly and answer any questions you have.

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.

Do I have a narrowed neck artery confirmed by a scan?
Am I already scheduled for surgery to remove plaque from my neck artery?
Do I have any autoimmune diseases or severe liver/kidney problems?
Am I pregnant, breastfeeding, or could I become pregnant?
Do I have an active infection or certain long-term viral infections (like HIV)?
Am I currently receiving active treatment for cancer?

Answer every question to see your result.

What does participation involve?

The detailed information about participation isn't fully provided in the brief summary. However, based on the information provided, participants would likely receive the Interleukin-2 (IL-2) medication. As the study focuses on changes within the plaque and participants are undergoing carotid endarterectomy, it's highly probable that samples from the removed plaque tissue will be collected and analysed. There will likely be blood tests to monitor immune cells and overall health, both before and after receiving IL-2. The duration of the IL-2 treatment and the number of follow-up visits are not specified, but such a study typically involves a series of closely monitored appointments.

Potential risks and benefits

Participating in this study might offer a potential benefit by helping to understand more about your condition and how the immune system affects it, which could contribute to developing future treatments. However, it's important to remember that this is a research study, and direct personal benefit from the IL-2 treatment is not guaranteed. As with any medication, there is a possibility of side effects from IL-2, and the research team will monitor you closely for these. The right to withdraw from the study at any time, for any reason, without affecting your standard medical care, is always maintained.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Addenbrookes Hospital
Verified postcode
Cambridge, United Kingdom

Common questions

What is a carotid artery plaque?

It's a build-up of fatty deposits inside the arteries in your neck that supply blood to your brain, which can narrow them and affect blood flow.

What is a TIA?

A TIA, or 'mini-stroke', is a temporary period of stroke-like symptoms caused by a brief interruption of blood flow to the brain, but it doesn't cause permanent brain damage.

What is Interleukin-2 (IL-2)?

IL-2 is a substance naturally produced by your body that plays a key role in the immune system. In this study, a low dose will be used.

Why is this research important?

It could help us understand how to use the body's own immune system to reduce inflammation in these plaques, potentially leading to better treatments for conditions like TIA and stroke.

Will taking part affect my planned surgery?

No, this study is for people already scheduled for carotid endarterectomy, which is standard care for your condition. Your surgery plans will not be affected.