| NCT ID | NCT06195800 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Sheffield Teaching Hospitals NHS Foundation Trust |
| Condition | Multiple Sclerosis, Relapsing-Remitting |
| Study Type | OBSERVATIONAL |
| Enrollment | 15 participants |
| Start Date | 2023-08-09 |
| Primary Completion | 2026-08-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 15 participants in total. It began in 2023-08-09 with a primary completion date of 2026-08-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The underlying disease mechanisms which occur in patients with immune mediation neurological diseases, such as Multiple Sclerosis (MS), are incompletely understood. For such patients, autologous haematopoietic stem cell transplantation (aHSCT) has been increasingly used as a highly successful one-off treatment for some patients. This treatment aims to delete the faulty immune system with a course of chemotherapy and then 'reboot' the immune system using a patients' own stem cells (a cell with the unique ability of being a building block to create many different cells in the body) to stop further damage. Over the last 20 years more than 1800 patients with MS have been treated in Europe with high levels of success. It may be more successful than disease modifying treatment but unfortunately, a small portion of people do not respond to this treatment optimally and continue to accumulate disability. There is a risk of side effects, restricted largely to the time of treatment, which necessitates the need to ensure appropriate patients are treated. Whilst aHSCT is a very effective therapy, it is still in its early phase of development, is not in widespread use, and there is incomplete knowledge regarding how it works and importantly, why it does not work in some patients, and how to monitor response to treatment. Unfortunately, there is no way of detecting which patients will, and will not, benefit from the different treatments available or a way of monitoring the immune system to ensure further treatment is provided before irreversible damage occurs. This study will investigate the immune system which is found in the fluid surrounding the brain and spinal cord, blood and stool of patients undergoing aHSCT and compare it to those receiving disease modifying treatment. This study will therefore further the understanding of biomarkers of aHSCT to develop an awareness of how it can be refined, may improve monitoring of patients following treatment and permit the development of markers which can predict potential treatment success or failure before patients are exposed to the risks.
Eligibility Criteria
Inclusion Criteria: 1. Diagnosis of a immune mediated neurological disease according to disease specific criteria (active treatment arm) or diagnosis of relapsing remitting multiple sclerosis (control arm). 2. Treatment with autologous haematopoetic stem cell transplantation (active treatment arm) or high efficacy disease modifying treatment (control arm). 3. Willing to provide biological samples for analysis and undergo clinical assessments for the duration of follow up. 4. Able to understand English and provide informed consent. Exclusion Criteria: 1\. Inability to provide informed consent.
Contact & Investigator
Gavin Brittain, MBBS, MRCP
PRINCIPAL INVESTIGATOR
Sheffield Teaching Hospitals NHS Foundation Trust and The University of Sheffield
Frequently Asked Questions
Who can join the NCT06195800 clinical trial?
This trial is open to participants of all sexes, aged 16 Years or older, studying Multiple Sclerosis, Relapsing-Remitting. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06195800 currently recruiting?
Yes, NCT06195800 is actively recruiting participants. Contact the research team at gavin.brittain@sheffield.ac.uk for enrollment information.
Where is the NCT06195800 trial being conducted?
This trial is being conducted at Sheffield, United Kingdom.
Who is sponsoring the NCT06195800 clinical trial?
NCT06195800 is sponsored by Sheffield Teaching Hospitals NHS Foundation Trust. The principal investigator is Gavin Brittain, MBBS, MRCP at Sheffield Teaching Hospitals NHS Foundation Trust and The University of Sheffield. The trial plans to enroll 15 participants.
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