REAL-MS: A Look at Autologous Stem Cell Transplant vs High-Efficacy MS Therapies in Real-World Care

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

REAL-MS is a multicenter, observational database study that follows adults with multiple sclerosis to compare the long-term effectiveness and safety of autologous hematopoietic stem cell transplantation (AHSCT) with high-efficacy disease-modifying therapies (HE-DMTs) used in real-world practice. Treatment decisions are made by clinicians and patients as part of standard care, not dictated by the study. The registry combines retrospective data from 2008 onward with a planned prospective phase starting in October 2026 to collect ongoing information. The study will explore overall outcomes, and may compare individual HE-DMTs if data quality and follow-up allow. No extra procedures are required beyond routine clinical care to participate.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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 Criteria:

* 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;
* 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;
* Lack of informed consent for prospective participation

Where it's running

• Imperial College Healthcare NHS Trust
  London, United Kingdom Recruiting
• King's College Hospital NHS Foundation Trust
  London, United Kingdom Not yet recruiting
• University College London Hospitals NHS Foundation Trust
  London, United Kingdom Not yet recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.