AI CuratorAI-generated
Research summary · AI summary · not yet reviewedHuman studyObservationalTrial registry
Immune Biomarkers in Patients with Relapsing Remitting Multiple Sclerosis: Observational Study on Autologous Haematopoietic Stem Cell Transplantation (aHSCT)
An observational study is currently recruiting 15 patients with relapsing remitting multiple sclerosis to investigate the immune profiles in those treated with autologous haematopoietic stem cell transplantation compared to those receiving high efficacy disease modifying treatment over 24 months.
- Tags
- #Biomarkers
- Most relevant to
- —
- Source
- Read original source
This plain-English summary was written by AI from a published abstract and may contain errors. It is not medical advice. Read the original study and talk to your MS team before making decisions about treatment.
Why it matters
Understanding immune biomarkers in aHSCT may help refine treatment and improve monitoring for patients, potentially allowing for predictions of treatment responses.
What this does not prove
No results are available yet, as the trial is still recruiting. The mechanisms of aHSCT in MS are not fully understood, and it remains unclear which patients might benefit from treatment.
Next milestone
No next milestone was established from the available source.
Study facts
- Study design
- Observational
- Participants / samples
- 15 · Estimated
- Randomised
- No
- Controlled
- Yes
- Primary endpoint met
- Not reported
- Relevant MS type
- RRMS
- Publication date
- Not reported
- Evidence reviewed
- Trial registry record
- Regulatory approval
- No
- Research areas
- Biomarkers
Original sources
Supporting passages (16)
study phaseThis 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.
study designThe underlying disease mechanisms which occur in patients with immune mediation neurological diseases, such as Multiple Sclerosis (MS), are incompletely understood.
subjectsWhilst 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.\n\nUnfortunately, 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.\n\nThis 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.
sample sizecount": 15, "type": "ESTIMATED"
sample size basiscount": 15, "type": "ESTIMATED"
randomizedobservationalModel": "CASE_CONTROL"
controlledThis 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.
regulatory approvalisFdaRegulatedDrug": false, "isFdaRegulatedDevice": false
research categoriesThe underlying disease mechanisms which occur in patients with immune mediation neurological diseases, such as Multiple Sclerosis (MS), are incompletely understood.
relevant ms typesDiagnosis of a immune mediated neurological disease according to disease specific criteria (active treatment arm) or diagnosis of relapsing remitting multiple sclerosis (control arm).\n2.
interventionPatients with aggressive disease treated with autologous haematopoetic stem cell transplantation.
comparator"description": "Patients with aggressive disease treated with high efficacy disease modifying treatment"
primary endpointQuantitatively and qualitatively characterise the immune profile of the stem cells, blood, cerebrospinal fluid (CSF) and the microbiome pre and post treatment.
follow up24 months
findingsThis 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."
limitationsUnfortunately, 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.
AI assessment, not yet reviewed by a person · version 1 · Community votes are separate from evidence review.