RecruitingOBSERVATIONAL

Biomarkers of aHSCT

This study aims to understand how a special type of stem cell transplant, called aHSCT, works for people with multiple sclerosis (MS) and similar neurological conditions. While aHSCT can be a very effective treatment, it doesn't work for everyone, and doctors don't fully understand why. Researchers will collect samples from people having aHSCT or other MS treatments to look at their immune system. By comparing these samples, they hope to find certain markers (biomarkers) that can predict who will benefit most from aHSCT. This could lead to better ways to monitor treatment and ensure people get the right care at the right time, avoiding unnecessary risks.

At a glance

Status

Recruiting

Sponsor

Sheffield Teaching Hospitals NHS Foundation Trust

Enrolment target

Start

09 Aug 2023

Estimated completion

09 Aug 2026

Multiple Sclerosis, Relapsing-Remitting

What is this study about?

This study is about a treatment called autologous haematopoietic stem cell transplantation, or aHSCT for short. This treatment has been used for some people with conditions like multiple sclerosis (MS), where the body's immune system mistakenly attacks healthy parts of the brain and spinal cord.

The idea behind aHSCT is to use strong chemotherapy to remove the 'faulty' immune system, and then 'reset' it by giving the person their own stem cells back. These stem cells are special building blocks that can grow into new, healthy immune cells. The hope is that this new immune system will stop attacking the body and prevent further damage. While aHSCT has helped many people, it's still quite new, not widely available, and doctors don't fully understand why some people do really well, while others don't respond as hoped.

Currently, there isn't a good way to know beforehand who will benefit most from aHSCT, or how to continuously check if the treatment is working well enough to prevent new damage. This study will collect samples of blood, bowel movements (stool), and fluid from around the brain and spinal cord from people having aHSCT. They will also compare these samples with those from people receiving other MS treatments. By looking at these samples, researchers hope to find clues (called biomarkers) that can explain how aHSCT works, why it sometimes doesn’t, and how to improve future treatments and monitoring for people with MS.

Key takeaways

The study explores why a stem cell transplant (aHSCT) works for MS patients.
It aims to find ways to predict who will benefit most from aHSCT.
Researchers will study immune system changes using blood, stool, and spinal fluid samples.
Participation involves providing samples and attending assessments, but won't change your current treatment.
The goal is to improve future treatments and monitoring for people with MS.

Who may be eligible?

To join this study, you generally need to have a diagnosis of multiple sclerosis (MS) or another immune-related brain or nerve condition. You would also either be having the aHSCT treatment or another highly effective treatment for your condition.

It's important that you are willing to give samples of your body fluids and blood for the study, and attend regular check-ups. You also need to be able to understand information in English and agree to take part in the study yourself.

Unfortunately, you wouldn't be able to join if you're unable to understand the study information and give your consent 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.

Do I have multiple sclerosis or a similar immune-related nervous system condition?
Am I currently receiving aHSCT or another highly effective MS treatment?
Am I willing to provide blood, stool, and spinal fluid samples?
Can I understand information in English and give my own consent to participate?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, the details of what you'll need to do will depend on whether you are receiving aHSCT or another treatment for MS. Generally, it will involve providing biological samples, such as blood, stool (poo), and fluid from around your brain and spinal cord. You will also have clinical assessments throughout a follow-up period. The study aims to collect this information over time to see how your immune system changes. The exact number of visits, how often, and the total duration will be explained fully by the study team, but it will involve some extra appointments alongside your usual medical care.

Potential risks and benefits

Taking part in this study has potential benefits, as it could help future patients by improving our understanding of aHSCT, leading to better predictions of who will benefit and how to monitor the treatment. However, it's important to remember that this study itself won't directly change your treatment plan. There are no direct medical benefits to you from participating, beyond the standard care you would receive for your condition. The main risks involve the procedures for collecting samples, such as blood draws or lumbar punctures (for spinal fluid), which have small risks like discomfort or bruising. You can choose to stop participating in the study at any time, 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.

Sheffield Teaching Hospitals NHS Foundation Trust
Verified postcode
Sheffield, United Kingdom· Recruiting

Common questions

What is aHSCT?

aHSCT is a treatment where your immune system is 'reset' using strong medicine and your own stem cells to treat conditions like MS.

Will this study change my MS treatment?

No, taking part in this study won't change the medical treatment you receive for your MS.

What kind of samples will be collected?

Researchers will collect samples of your blood, stool (poo), and fluid from around your brain and spinal cord.

Why are these samples needed?

The samples help researchers understand how your immune system reacts to treatment and why it works differently for different people.

Can I leave the study if I change my mind?

Yes, you are free to leave the study at any time, and it will not affect your medical care.

How to find out more

Gavin Brittain, MBBS, MRCP

gavin.brittain@sheffield.ac.uk +44114 271 1900 Official trial record

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