Comparing stem cell transplant with strong medicines for adults with multiple sclerosis
Compares stem cell transplant and strong medicines in adults with multiple sclerosis.
Plain-language title generated from the registry record
Registry title: REAL-MS: Observational Database Study of AHSCT and MS Therapies
Key facts
- Where
- London, United KingdomSee the 3 sites
Where in United Kingdom
- Imperial College Healthcare NHS TrustLondon, United KingdomTaking people
- King's College Hospital NHS Foundation TrustLondon, United KingdomNot yet recruiting
- University College London Hospitals NHS Foundation TrustLondon, United KingdomNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Imperial College London
- Trial code
- NCT07899502
- Record updated
- 27 October 2026
- Original description
Multiple sclerosis (MS) is a condition in which the immune system damages the brain and spinal cord. Treatments called disease-modifying therapies can reduce inflammation and disease activity. For some people with highly active MS, autologous haematopoietic stem cell transplantation (AHSCT) may be used. AHSCT uses a person's own blood-forming stem cells after treatment that suppresses the immune system.Read full original descriptionShow less
Real-World Effectiveness and Safety of Autologous Haematopoietic Stem Cell Transplantation and Other Therapeutic Strategies in Multiple Sclerosis (REAL-MS) - An Observational Database Study
Multiple sclerosis (MS) is a condition in which the immune system damages the brain and spinal cord. Treatments called disease-modifying therapies can reduce inflammation and disease activity. For some people with highly active MS, autologous haematopoietic stem cell transplantation (AHSCT) may be used. AHSCT uses a person's own blood-forming stem cells after treatment that suppresses the immune system.
REAL-MS is an observational study that will collect and analyse information from routine clinical care to compare the longer-term effectiveness and safety of AHSCT with high-efficacy disease-modifying therapies for adults with MS. High-efficacy therapies include medicines such as alemtuzumab, cladribine, natalizumab, and anti-CD20 antibody treatments, as well as other high-efficacy disease-modifying therapies that may become available during the study.
Inclusion: Diagnosis of MS according to the appropriate diagnostic criteria at the time of diagnosis; Age ≥ 18 years old at the time of the inclusion in the study; Treatment with AHSCT or a H-E DMT at a participating centre. Eligible H-E DMTs will include anti-CD20 monoclonal antibodies, natalizumab, alemtuzumab, cladribine, and other therapies approved by the study management group during the study period; Availability of a minimum required baseline dataset as defined in the study case report form and data dictionary; Availability of at least one post-baseline clinical assessment, unless the patient is included in safety analyses only; For participation in the prospective phase of the study, capacity to provide informed consent, as judged by the investigator, and provision of written informed consent where required by applicable local regulations and ethics approvals.
Exclusion: Concurrent participation in an interventional randomised controlled trial where inclusion in the study would conflict with the trial protocol or compromise interpretation of study outcomes; Age <18 years at the time of study inclusion; Insufficient baseline data to confirm eligibility, treatment exposure, or key study variables; No post-baseline follow-up data, unless the participant is included in safety analyses only; Lack of informed consent for prospective participation.