People with aggressive multiple sclerosis (MS) could be offered haematopoietic stem cell transplants as part of a £2.3 million world-first trial.
Launched by the University of Sheffield and Sheffield Teaching Hospitals NHS Foundation Trust, the StarMS study will trial the therapy in patients with highly active MS that have not responded to drug treatment, or as a first-line treatment for patients with aggressive disease.
It will be the first study to compare how effective autologous haematopoietic stem cell transplantation (AHSCT) is compared with four other drug treatments – alemtuzumab, ocrelizumab, ofatumumab and cladribine – that have shown to be effective in clinical trials to reduce disease activity and disability accumulation.
The research team say that when it is complete, the findings of the StarMS trial, which is being run in 19 sites across the UK, could revolutionise care for thousands of people who suffer with MS.
The StarMS study builds on the landmark MIST trial, which was the first in the world to show that stem cell transplantation could reverse disability in patients with MS. The MIST trial also identified that AHSCT worked better than the disease-modifying drugs available at the time.
Chief investigator Professor John Snowden, honorary professor at the University of Sheffield and consultant haematologist at Sheffield Teaching Hospitals NHS Foundation Trust, added: “Autologous haematopoietic stem cell transplantation 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.”
Lead trial neurologist Professor Basil Sharrack, honorary professor of clinical neurology at the University of Sheffield and consultant neurologist at Sheffield Teaching Hospitals NHS Foundation Trust, said: “Currently, there is no cure for multiple sclerosis, but huge advances have been made in recent years, with the MIST trial offering renewed hope for people living with this devastating condition. We now want to bring this research up to date by taking into account all the latest advances in treatments.
“This could also provide us with the solid evidence we need to demonstrate that AHSCT can be offered as a first line treatment for those with the aggressive form of the condition.”
The research team will also undertake hypothesis-driven studies in the laboratory to understand the precise mechanism that enables AHSCT to successfully treat patients. They will also use various biomarkers to see how well the body responds to the five treatments being offered in the trial.
Source: University of Sheffield / Sheffield Teaching Hospitals NHS Foundation Trust
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