Pioneering trial for multiple sclerosis patients launches in Southampton
Doctors at University Hospital Southampton (UHS) have launched a groundbreaking trial to find out if using stem cell therapy could halt progression of the debilitating disease multiple sclerosis (MS).
MS is a condition which occurs when the immune system attacks the protective lining of the nerve fibres in the brain and spinal cord, causing damage and scarring.
This can lead to a range of symptoms including movement, vision and balance problems, numbness and tingling and muscle stiffness and spasms which gradually worsen.
The world-first StarMS study will assess whether or not autologous hematopoietic stem cell transplantation (AHSCT) – a therapy using the patient’s own stem cells – can reboot the immune system and delay or stop the progression of the disease.
It offers new hope to those living with the condition with leading experts hoping to identify evidence to support its roll-out in the future.
While AHSCT is available, it is only currently used if other treatments have failed, however, an earlier study showed it may have the potential to delay or halt further progression of MS symptoms.
It will be compared against existing treatments which use licensed drugs known as disease modifying therapies (DMT) – with these treatments only able to reduce the worst symptoms, not prevent deterioration.
Researchers are now aiming to establish if the therapy should be used as a first-line treatment.
The therapy works by harvesting (removing) the patient’s blood and bone marrow stem cells and then stripping the body’s immune system using chemotherapy.
The stem cells are then transplanted back to reset the body’s immune system and prevent further damage.
Participants will be split in to two randomised groups receiving either AHSCT treatment or DMT treatment and will be followed up over the course of 24 months with blood tests, neurological examinations and regular visits with the study team.
UHS is one of 19 sites across the UK taking part in the £2.3m study, which is led by Sheffield Teaching Hospitals NHS Foundation Trust.
It is open to people with an ‘aggressive’ form of the condition or those who are not responding to current treatment.
MS affects around 100,000 people in the UK and 2.3 million globally and currently has no cure.
One trial participant is Andy Ling, 37 from Brighton who was diagnosed with MS in October 2020 when he started having problems with his balance.
He first noticed issues with his eyesight and felt odd sensations in his hands and feet, such as numbness and tingling.
His symptoms were initially attributed to his recent back surgery but a scan during a trip to his local emergency department revealed that he had MS.
“I’m acutely aware of my body and who I am,” he explained. “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 said. “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.
Following his diagnosis, he heard about the StarMS trial through other people with the condition and raised it with his neurologist.
As it is a randomised trial, Andy and the clinical team don’t yet know if he will be on the new AHSCT treatment or current DMT treatment but despite this he feels “grateful” to be able to take part as it’s helped him feel “more in control”.
He added: “You don’t have control over MS, but I have control over whether I take part in something which could potentially help others.
"I feel really grateful to be taking part in this trial which I hope will give evidence to help other people diagnosed with MS now and in the future.
“If I’m admitted for the stem cell transplant and we find that it halts the progression of the disease, that’s a life-changer, for me and thousands of other people.”
Dr Kim Orchard, consultant haematologist, and Professor Ian Galea consultant neurologist, both from UHS have collaborated to deliver StarMS across two specialities at the Trust – cancer sciences and neurology.
Dr Orchard, who is also the study principal investigator in Southampton, said:
This study is the first to use stem cell transplantation relatively early in the course of MS and could provide the strongest evidence that autologous transplantation can become an important option for the treatment of the disease.
“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, also a professor in clinical and experimental neurology at the University of Southampton, 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."
Patients who are interested in taking part in the StarMS trial should contact their treating neurologist who will decide if they are eligible and may be referred to a participating StarMS centre.
The trial is funded through a partnership between the National Institute for Health and Care Research (NIHR) and Medical Research Council (MRC).