World-first stem cell trial for MS patients starts in Southampton

The first patient at University Hospital Southampton (UHS) has joined a ground-breaking new trial investigating the effectiveness of stem cell transplants to treat ‘aggressive’ multiple sclerosis (MS).

The national £2.3m StarMS study will assess how effectively autologous hematopoietic stem cell transplantation (AHSCT) can treat certain people living with MS.

It follows research showing that transplants using the patient’s own stem cells could reverse disability with MS.

Researchers will compare AHSCT against the current standard of care.

Finding the best treatments

MS is the most common chronic inflammatory condition of the central nervous system in young adults. It affects 100,000 people in the UK, and 2.3 million globally.

The StarMS trial will build on the results of the MIST trial. This showed AHSCT was better at reducing the risk of increased disability than the drugs available at the time. But since then, four drugs – alemtuzumab, ocrelizumab, ofatumumab and cladribine – have been shown to slow progression and reduce disability in trials.

StarMS will compare the effectiveness and safety of AHSCT against these promising treatments.

The researchers will use the results to assess if AHSCT should be used as a first-line treatment for patients with aggressive MS. They will also investigate how AHSCT treatment works.

Andy Ling’s experience

StarMS participant Andy Ling first realised something was wrong when he started having problems with his balance. He noticed he was having issues with his eyesight, and felt odd sensations in his hands and feet, such as numbness and tingling.

“I’m acutely aware of my body and who I am,” he explains. “I used to be a dancer, so as soon as I started getting symptoms, I was really aware of how it was impacting me.”

He now works for the University of Brighton, but still found that his symptoms affected his day-to-day life.

“It was impacting my work,” he says. “I couldn’t type on the keyboard properly, couldn’t hold a pen, couldn’t write my name, couldn’t tie my shoelaces up. That kind of thing.”

He was diagnosed in 2020, during the COVID-19 pandemic lockdown. His symptoms were initially attributed to his recent back surgery, but a scan during a trip to A&E revealed that he had MS.

Following his diagnosis, he became interested in stem cell transplants. He heard about the StarMS trial through other people with the condition, and raised it with his neurologist. He initially joined the trial at a site in London, but after they paused recruitment, decided to move to Southampton.

“I came to Southampton, and it felt like it was the right decision,” he says. “From the moment I made contact with the research team, it just felt like I wasn’t a number. I felt like I was a person, and I was going through something potentially quite major.”

Research a potential ‘life-changer’

Getting to this stage has not been easy. There have been lots of tests, and issues that needed resolving, before he could take part. The emotional strain of this has taken its toll, he says, but being able to pick up the phone and call a member of the trial team has helped.

Despite the challenges, he’s grateful to be able to take part in the trial. He says it’s helped him feel more in control, and explains that the benefits of taking part far outweigh the costs.

“You don’t have control over MS, but I have control over whether I take part in something which could potentially help others,” he says.

“What I’m doing, by taking part in this trial, will give us the evidence to help other people that are diagnosed with MS.

“If I’m admitted for the stem cell transplant and we find that it halts the progression of my MS, that’s a life-changer, for me and thousands of other people.”

‘Shifting’ treatment landscape

UHS is one of 19 UK sites in the trial, led by researchers at Sheffield Teaching Hospitals NHS Foundation Trust and the University of Sheffield’s Clinical Trials Research Unit.

It is funded through a partnership between the National Institute for Health and Care Research (NIHR) and Medical Research Council (MRC).

Professor John Snowden, Chief Investigator and Consultant Haematologist at Sheffield Teaching Hospitals NHS Foundation Trust, said:

“AHSCT has been shown to be highly effective in stabilising, and even reversing disability, in certain patients with multiple sclerosis. But the treatment landscape in this condition has shifted since the original MIST trial.

“The trial will measure how good and safe AHSCT is when compared head-to-head with the latest leading treatments for multiple sclerosis. In this way, we hope to determine the exact place of AHSCT in the modern treatment pathways for patients with severe multiple sclerosis.

“Such translational research may also offer important insights into the fundamental immune system abnormalities that cause MS in the first place.”

In Southampton, Dr Kim Orchard, the study Principal Investigator, and Professor Ian Galea have collaborated to deliver StarMS across two specialities – cancer sciences and neurology.

Dr Orchard, Consultant Haematologist and previous Director of the Wessex Blood and Marrow transplant and Cellular Therapy Program in Southampton, said:

“This study is the first to use stem cell transplantation relatively early in the course of MS. As a large, randomised, multi-centre trial, we hope to obtain evidence whether transplantation should be used earlier in MS and therefore may be of greater benefit to patients in the future.

“This is a great example of where two teams can work collaboratively to deliver a complex therapy, based on the existing transplant and cellular therapy program in Southampton and the research teams. We have a fantastic team which is very experienced in the delivery of safe care for vulnerable patients.”

Prof Galea, Consultant Neurologist and Professor in Clinical & Experimental Neurology, said:

“In this trial, we are asking a very important question for people with MS who are not yet on treatment but have a severe course, or who have not responded to first line treatment: is treating with AHSCT better than using our best disease-modifying drugs?

“At one year, people can switch between AHSCT and disease modifying drugs, if they do not respond to the treatment they were randomly assigned to at the beginning of the trial.

“People like Andy participating in the trial are at the forefront of research helping to improve the lives of many with MS.”