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 aHSCT against Ocrevus (ocrelizumab), Mavenclad (cladribine), Kesimpta (ofatumumab) and Lemtrada (alemtuzumab), four 'highly effective' disease modifying drugs (DMDs). The study is operating across several hospital sites across the UK, and has recruited 94 participants.
Half of the participants have been randomly allocated to have HSCT, and the other half have been allocated to have one of the 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.
Recruitment for the trial was completed in November 2024 and the results are expected in July 2027. You can read more in the Star-MS trial website.