Understanding biomarkers in patients with Multiple Sclerosis receiving stem cell treatment
Identifying Immune Biomarkers of Disease and Disease Control in Autoimmune Neurological Disease Using Autologous Haematopoietic Stem Cell Transplantation
This study is trying to find out if certain biological markers can help predict how well stem cell treatment works for people with relapsing-remitting Multiple Sclerosis.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 15 (estimated) |
| Ages | 16 Years and up |
| Sex | All |
| Sponsor | Sheffield Teaching Hospitals NHS Foundation Trust Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Sheffield, England) |
| Trial ID | NCT06195800 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate the underlying disease mechanisms in patients with relapsing-remitting Multiple Sclerosis (MS) who have undergone autologous haematopoietic stem cell transplantation (aHSCT). By analyzing biological samples and conducting clinical assessments, the study seeks to identify biomarkers that may predict treatment response and disease progression. The research builds on the experience of over 1800 patients treated in Europe, focusing on improving outcomes for those who do not respond optimally to aHSCT. The findings could enhance understanding of MS and inform future treatment strategies.
Who should consider this trial
Good fit: Ideal candidates include individuals diagnosed with relapsing-remitting Multiple Sclerosis who are willing to provide biological samples and undergo clinical assessments.
Not a fit: Patients who are unable to provide informed consent or do not have a diagnosis of an immune-mediated neurological disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment strategies and outcomes for patients with Multiple Sclerosis.
How similar studies have performed: Other studies have shown success with similar approaches in understanding biomarkers and treatment responses in Multiple Sclerosis, suggesting potential for meaningful insights.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Sheffield, England
- Sheffield Teaching Hospitals NHS Foundation Trust — Sheffield, England, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Gavin Brittain, MBBS, MRCP — Sheffield Teaching Hospitals NHS Foundation Trust and The University of Sheffield
- Study coordinator: Gavin Brittain, MBBS, MRCP
- Email: gavin.brittain@sheffield.ac.uk
- Phone: +44114 271 1900
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.