Actively Recruiting
Identifying Immune Biomarkers of Disease and Disease Control in Autoimmune Neurological Disease Using Autologous Haematopoietic Stem Cell Transplantation
Led by Sheffield Teaching Hospitals NHS Foundation Trust · Updated on 2024-01-08
15
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
S
Sheffield Teaching Hospitals NHS Foundation Trust
Lead Sponsor
S
Sheffield Hospitals Charity
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying the immune system changes in patients with immune-mediated neurological diseases like Multiple Sclerosis (MS), focusing on those receiving autologous haematopoietic stem cell transplantation (aHSCT) or disease modifying treatments. The study aims to better understand how aHSCT works, why it may not benefit some patients, and to identify biomarkers that can predict treatment success or failure to improve patient monitoring and care. The study observes two groups of patients: those with aggressive disease treated with aHSCT, which involves chemotherapy to reset the immune system followed by reinfusion of the patient's own stem cells, and those treated with high efficacy disease modifying treatments. Researchers will collect and compare samples of stem cells, blood, cerebrospinal fluid, and stool from both groups to analyze immune profiles before and after treatment over a 24-month period. Participants will provide biological samples and undergo clinical assessments for up to two years. Researchers will use advanced techniques such as single cell RNA sequencing to examine immune cells and the microbiome. The study will also assess disease response and function using various scales including the expanded disability status scale, visual acuity tests, and cognitive assessments, aiming to track immune system regeneration and treatment impact over time.
CONDITIONS
Brief Title
Biomarkers of aHSCT
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of an immune mediated neurological disease or relapsing remitting multiple sclerosis.
- Treatment with autologous haematopoietic stem cell transplantation or high efficacy disease modifying treatment.
- Willingness to provide biological samples for analysis and undergo clinical assessments for the duration of follow up.
- Ability to understand English and provide informed consent.
You will not qualify if you...
- Inability to provide informed consent.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 24 months
Participants who undergo routine care are observed with collection of biological samples and clinical assessments to characterize immune profiles and evaluate disease response over time.
Multiple visits over 24 months for sample collection and clinical assessments
Trial Site Locations
Total: 1 location
1
Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield, England, United Kingdom, S10 2JF
Actively Recruiting
Research Team
G
Gavin Brittain, MBBS, MRCP
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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