StarMS Trial

Autologous Stem Cell Transplantation versus Alemtuzumab, Ocrelizumab, Ofatumumab or Cladribine in Relapsing-Remitting Multiple Sclerosis (MS).



Multiple Sclerosis (MS) is a disease of the central nervous system that affects 2.3 million people worldwide. It is caused by an autoimmune reaction that damages nerve cells. This damage to the nerve cells interrupts signals and results in a wide range of symptoms that can affect movement, eyesight and cognition.

Around 85% of people who are diagnosed with MS have relapsing-remitting MS (RRMS). There is no cure for MS, but some RRMS patients respond well to Disease Modifying Therapies.

More recently, Autologous Haematopoietic Stem Cell Therapy (aHSCT) has shown promise for treating a number of autoimmune diseases, including RRMS. Haematopoietic stem cells are young cells that have the potential to become mature immune cells. These cells are collected from patients, by a process called mobilisation. The patients then undergo chemotherapy to wipe out their overactive immune cells (conditioning), before the stem cells are infused back into the bloodstream.

There is growing clinical evidence that aHSCT can treat RRMS more effectively than DMTs. However, as most data is registry-based and previous trials did not directly compare aHSCT with the most efficacious DMTs, Alemtuzumab, Ocrelizumab, Cladribine and Ofatumumab, questions remain over the relative efficacy and safety of aHSCT over the UK standard of care for highly active RRMS. The StarMS trial aims to address these questions

The StarMS trial

StarMS aims to compare the efficacy and safety profile of Autologous Haematopoietic Stem Cell Transplantation (aHSCT) vs ‘highly effective’ Disease Modifying Therapies (DMTs) – Ocrelizumab, Alemtuzumab, Cladribine and Ofatumumab. The study will also research the mechanism of action to help our understanding of how aHSCT works in RRMS.

The study aims to recruit 198 patients from 19 sites across the UK. Participants in the study will be randomly allocated to receive either aHSCT or treatment with a ‘highly effective’ DMT (Alemtuzumab, Ocrelizumab, Cadribine, or Ofatumumab). Participants allocated to the aHSCT arm will have stem cells removed (harvested) from the blood. Participants will then undergo ‘conditioning’ where the patients receive chemotherapy before their stem cells are transplanted (re-infused) into the participants’ blood. The re-infused stem cells give rise to a new generation of immune cells, replacing the original ‘sick’ immune system.

Participants allocated to the DMT arm will receive either Alemtuzumab, Ocrelizumab, Cladribine, or Ofatumumab administered and monitored as per licence. This decision will be based on the participant’s suitability for each drug based on current guidelines as well as clinician/participant preference.

All participants will be followed up over a 24-month period involving regular visits with the study team. Study visits will include blood tests, neurology examinations and questionnaires.

More information about the trial can be found on our trial website.

Participating sites

Site Status
Bart's and the London NHS Trust Open
University Hospitals Birmingham NHS Foundation Trust In set-up
Cambridge University Hospitals NHS Foundation Trust Open
Cardiff & Vale University Health Board In set-up
NHS Greater Glasgow and Clyde Open
Imperial College Healthcare NHS Trust Open
King's College Hospital NHS Foundation Trust Open
Leeds Teaching Hospitals NHS Trust Open
NHS Lothian Open
The Newcastle upon Tyne Hospitals NHS Foundation Trust In set-up
North Bristol NHS Trust In set-up
Nottingham University Hospitals NHS Trust Open
Oxford University Hospitals NHS Foundation  In set-up
University Hospitals Plymouth NHS Trust Closed
Salford Royal NHS Foundation Trust In set-up
Sheffield Teaching Hospitals NHS Foundation Trust Open
University Hospital Southampton NHS Foundation Trust Open
The Walton Centre NHS Foundation Trust In set-up
University College London Hospitals NHS Foundation Trust Open

Study team

Name Role Organisation Contact
Professor John Snowden Chief Investigator Sheffield Teaching Hospitals NHS Foundation Trust
Professor Basil Sharrack Lead Trial Neurologist Sheffield Teaching Hospitals NHS Foundation Trust
Professor Paolo Muraro Lead Trial Neurologist Imperial College Healthcare NHS Trust
Professor Cindy Cooper Director, CTRU CTRU, University of Sheffield
Diana Papaioannou Assistant Director, CTRU CTRU, University of Sheffield
Professor Stephen Walters Senior Statistician CTRU, University of Sheffield
Amanda Loban Head of Data Management CTRU, University of Sheffield
Joshua Milner Trial Support Officer CTRU, University of Sheffield
Rachel Glover Trial Manager CTRU, University of Sheffield
Kate Duffy Research Assistant CTRU, University of Sheffield
Kate Hutchence Research Assistant CTRU, University of Sheffield
Rowena Seaton Kelly Research Assistant CTRU, University of Sheffield

Generic email for StarMS trial:

Funder and sponsor

This project is funded by the Efficacy and Mechanism Evaluation (EME) Programme, an MRC and NIHR partnership. The views expressed in this publication are those of the author(s) and not necessarily those of the MRC, NIHR or the Department of Health and Social Care. The sponsor is the Sheffield Teaching Hospitals NHS Foundation Trust.

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