StarMS research study

Autologous stem cell transplantation versus alemtuzumab or ocrelizumab in relapsing remitting multiple sclerosis

On
Star MS ScHARR

Background

Multiple Sclerosis (MS) is a disease of the central nervous system that affects 2.3 million people world-wide. 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 and Ocrelizumab, 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 aHSCT vs ‘highly effective’ DMTs – Ocrelizumab and Alemtuzumab. 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 or Ocrelizumab). 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 or Ocrelizumab 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.


Participating sites

All sites are currently in the set-up stage. This page will be updated as sites begin to open to recruitment. In the meantime, please direct any queries to star-ms@sheffield.ac.uk

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

Study team

Name Role Organisation Contact
Prof John Snowden Chief Investigator Sheffield Teaching Hospitals NHS Foundation Trust John.snowden1@nhs.net
Prof Basil Sharrack Lead Trial Neurologist Sheffield Teaching Hospitals NHS Foundation Trust Basil.sharrack@nhs.net
Prof Paolo Muraro Lead Trial Neurologist Imperial College Healthcare NHS Trust p.muraro@imperial.ac.uk
Prof Cindy Cooper Director, CTRU CTRU, University of Sheffield

c.l.cooper@sheffield.ac.uk

Tel: +44 114 22 20743

Diana Papaioannou (on Maternity Leave) Assistant Director, CTRU CTRU, University of Sheffield

d.papaioannou@sheffield.ac.uk

Tel: +44 114 222 0766

Jennifer Petrie Trial Manager CTRU, University of Sheffield

j.petrie@sheffield.ac.uk

Tel: +44 114 222 0676

Sarah Connelly Research Assistant CTRU, University of Sheffield

s.l.connelly@sheffield.ac.uk

Tel: +44 114 22 22982

Rachel Glover Research Assistant CTRU, University of Sheffield

r.e.glover@sheffield.ac.uk

Tel: +44 114 22 24265

Prof Stephen Walters Senior Statistician CTRU, University of Sheffield

s.j.walters@sheffield.ac.uk

Tel: +44 114 222 0730

Amanda Loban Head of Data Management CTRU, University of Sheffield a.loban@sheffield.ac.uk
Tel: +44 114 222 2995
Zoe Furniss Trial Support Officer CTRU, University of Sheffield

z.furniss@sheffield.ac.uk

Tel: +44 114 225 9122


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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