CompletedInterventional

Autologous stem cell transplantation versus alemtuzumab, ocrelizumab, ofatumumab or cladribine in relapsing-remitting multiple sclerosis

Multiple sclerosis (MS) occurs when the body's immune system mistakenly attacks the nerves. In relapsing-remitting MS (RRMS), this causes sudden flare-ups followed by periods of recovery. While powerful medicines can help, doctors want to know if resetting the immune system with a stem cell transplant works even better. The UK-wide StarMS study compares stem cell transplantation against four highly effective drugs: alemtuzumab, ocrelizumab, ofatumumab, and cladribine. Participants are randomly allocated to receive either the stem cell treatment or one of the four medications, chosen with their doctor. Researchers will follow each participant for two years to compare safety, relapse rates, thinking and memory skills, and overall quality of life. The study provides regular check-ups, and travel expenses are covered.

At a glance

Status

Completed

Sponsor

Sheffield Teaching Hospitals NHS Foundation Trust

Enrolment target

198

Start

01 Sep 2021

Estimated completion

30 Sep 2024

Relapsing-remitting multiple sclerosis

What is this study about?

Relapsing-remitting multiple sclerosis (RRMS) is a long-term condition where the immune system attacks the protective layer around nerves in the brain and spinal cord. This can lead to problems with balance, vision, muscle strength, and fatigue. People with RRMS experience flare-ups of symptoms (relapses), followed by quieter periods where symptoms improve (remissions).

Doctors currently use several strong medications, known as disease-modifying therapies, to help calm the immune system and reduce attacks. However, a treatment called autologous haematopoietic stem cell transplantation (aHSCT) might offer an even deeper reset. In aHSCT, doctors collect a patient's own healthy blood stem cells, use medicine to clear away the faulty immune cells, and then return the stem cells to grow a fresh, healthy immune system.

The StarMS trial is designed to compare aHSCT directly against the four most effective NHS-approved MS drugs: alemtuzumab, ocrelizumab, ofatumumab, and cladribine. Because doctors do not yet know for sure which route gives the best balance of benefits and safety, this trial will provide vital answers to guide future MS care across the UK.

Key takeaways

StarMS compares a stem cell transplant directly against four leading MS medications.
It is open to people aged 16 to 55 with active relapsing-remitting MS.
A computer decides whether you receive stem cell therapy or a modern medication.
The study lasts two years and includes extra monitoring from specialist nurses and doctors.
Reasonable travel expenses for hospital visits are reimbursed.

Who may be eligible?

This study is for adults aged 16 to 55 who have been diagnosed with relapsing-remitting MS that is still very active. This means you have had a flare-up or new spots showing on an MRI scan in the past 12 months despite taking standard medication, or your MS has worsened rapidly since diagnosis.

To take part, you must be able to walk (with or without a walking aid) and be well enough to undergo intensive treatment, as assessed by hospital specialists. Your condition must also have been stable for at least 30 days since your last relapse, and you must be able to have regular MRI scans.

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 between 16 and 55 years old.
I have been diagnosed with relapsing-remitting multiple sclerosis (RRMS).
My MS has been active in the past year (flare-ups or new MRI activity) despite treatment, or is rapidly worsening.
It has been at least 30 days since my last relapse.
I am able to walk, either on my own or using a walking stick or frame.
I am able to have MRI scans.

Answer every question to see your result.

What does participation involve?

Taking part lasts for two years. A computer will randomly place you into one of two groups: stem cell transplantation (aHSCT) or medication. If you are in the stem cell group, your stem cells will be gathered from your blood and frozen. You will receive chemotherapy in hospital to wipe out your current immune cells before your stem cells are put back through a drip to rebuild your immune system. If you are in the medication group, you and your doctor will pick the most suitable drug from four options, given either by drip, regular self-injection, or tablets. Throughout the two years, you will attend regular hospital appointments for MRI scans, blood tests, and checks on your memory and physical health. You will also have direct contact with a study nurse, and your travel expenses will be reimbursed.

Potential risks and benefits

You may benefit from close, regular care from a specialist team and help doctors understand the best way to treat active MS in the future. However, all treatments involved carry side effects, including a temporary drop in infection-fighting blood cells, fatigue, and other drug-specific risks. A stem cell transplant is an intensive procedure requiring time in hospital. Your medical team will explain every risk in plain detail before you agree to take part, and you are completely free to leave the trial at any time without your regular NHS care being affected.

Locations (15)

Sheffield Teaching Hospitals NHS Foundation Trust
City only
Sheffield, England
Leeds Teaching Hospitals NHS Trust
City only
Leeds, England
NHS Lothian
Approximate
Edinburgh, Scotland
NHS Greater Glasgow and Clyde
City only
Glasgow, Scotland
The Newcastle Upon Tyne Hospitals NHS Foundation Trust
City only
Newcastle-upon-Tyne, England
Salford Royal NHS Foundation Trust
Unverified
Salford, England
Nottingham University Hospitals NHS Trust
Unverified
Nottingham, England
The Walton Centre NHS Foundation Trust
Unverified
Liverpool, England
Cambridge University Hospitals NHS Foundation Trust
Unverified
Cambridge, England
University Hospital Southampton NHS Foundation Trust
Unverified
Southampton, England
Imperial College Healthcare NHS Trust
Unverified
London, England
King's College Hospital NHS Foundation Trust
Unverified
London, England

Common questions

Can I choose which treatment I receive?

No. A computer randomly decides whether you receive a stem cell transplant or a standard drug treatment to keep the test fair and balanced. However, if you are assigned to the drug group, you and your doctor will decide together which of the four medicines is best for you.

Are the stem cells taken from someone else?

No. The procedure uses your own stem cells, which are collected from your bloodstream, safely stored, and given back to you later.

Will taking part cost me anything?

No. The treatments and tests are provided through the study, and you can claim back reasonable travel costs for your extra hospital visits.

What happens if my MS gets worse during the trial?

Your study doctors will monitor you closely. If your treatment is not working or your health changes, they will step in to adjust your care and keep you safe.

Where is the study taking place?

The study is run by the University of Sheffield and takes place at specialist NHS hospital trusts across the UK.

How to find out more

Rachel Glover

r.e.glover@sheffield.ac.uk +44 (0)114 222 4265 Official trial record

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