There is growing evidence that Autologous Haematopoietic Stem Cell Transplantation (aHSCT or HSCT) is an effective treatment for relapsing remitting MS. However, there has not yet been a direct comparison of HSCT against the most effective disease modifying drugs currently available. This makes it hard to assess the relative risks and benefits of HSCT for people with MS.
The Star-MS trial aims to compare the efficacy and safety of HSCT against Ocrelizumab (Ocrevus) and Alemtuzumab (Lemtrada), two 'highly effective' disease modifying drugs (DMDs). The study will be operating across 19 hospital sites across the UK, and aims to recruit 198 participants.
Half of the particpants will be randomly allocated to have HSCT, and the other half will be allocated to have one of the two DMDs. All participants will be followed up over a 24 month period, having regular visits with the study team. During these visits, they will have blood tests, neurology examinations and questionnaires to complete.
When complete, the Star-MS trial will give clinical teams better understanding of how to use HSCT in treating people with RRMS. More hospitals around the UK will have developed experience in delivering HSCT as a treatment for MS. This should make it easier for eligible people to get access to stem cell transplantation in the UK in the future.
You can read more in the Star-MS trial website.
How can I take part?
If you are interested in taking part in the StarMS trial, you should first contact your own neurologist. If they think you may be eligible, you may then be referred to a participating StarMS centre.
You may be eligible to take part in the Star-MS trial if the following conditions apply to you:
You are aged between16 and 55 years old
You have a diagnosis of relapsing remitting MS
You have experienced 2 or more relapses, or 1 relapse and evidence of MRI activity at a separate time point, in the preceding 12 months despite taking a DMD
You have an EDSS score of 0-6.0 (EDSS 0-1.5 must be accompanied by poor prognosis, EDSS 6.0 must be due to relapse rather than progressive disease)
You have been clinically stable for at least 30 days following your last relapse
Unfortunately, if the following criteria apply to you, you would not be eligible for the trial:
You have a diagnosis of primary or secondary progressive MS
You have had MS for more than 10 years
You have previously had treatment with Alemtuzumab, Ocrelizumab, Cladribine or HSCT
If you have certain other medical conditions as well as MS.
All hospital visits and treatment received during the trial will take place at the hospital that is taking part in the StarMS trial. This might not be the closest hospital to where you live, or the hospital where you are currently are treated. It is important to think about location when considering whether to take part. The Star-MS website has a map to show the Star-MS hospital locations.