ArticleBiomarker insights2025
A Comprehensive Description of the Roadmap to Identify and Validate a Myelin Biomarker.
Article in Biomarker insights, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
1 citing paper in PubMed.
Corrections and comments
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Authors and funding
18 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Background: Demyelination and remyelination are major issues for scientists dealing with myelin disorders in both clinical and research fields. Despite that, rapid, reliable and convenient tools to monitor myelin changes still lack both in central and peripheral nervous system. Given that myelin is enriched in specific lipids and proteins, it is reasonable they could represent eligible candidates as structural damage biomarkers for this characteristic membrane. Among them, we focused on sphingomyelin (SM) due to the enrichment in myelin and because it is easily measurable in different biological matrices. Objective: Depicting the roadmap to identify and validate SM dosage as a myelin biomarker useful for pre-clinical and clinical practice. Design: This study adheres to STROBE guidelines for observational cross-sectional studies on human patients and to ARRIVE guidelines for animal models. Method: Following the recommendations of the Society for CSF Analysis and Clinical Neurochemistry, we describe the stepwise process to validate SM as a myelin biomarker, starting from the optimization of the fluorescence-based assay and analytical validation in experimental models until clinical and pathological validation in biological fluids of neurological patients. Results: SM dosage monitors myelination, demyelination, remyelination and even small myelin changes associated to myelin pathology and pharmacological treatments in experimental models. SM is detectable in human biological fluids and informative of myelin damage in the CSF of neurological patients. SM dosage identifies myelin breakdown in the CSF of patients affected by Guillain-Barrè Syndrome (GBS) and Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP), identifying disease activity, axonal from demyelinating variants, and avoiding misdiagnosis. Conclusion: SM dosage displayed extremely promising real-word performances being able to identify, monitor and stage myelin pathology. Given that it is simple, inexpensive and easily adaptable to routine use in any hospital setting, it might rapidly progress to the implementation and impact on clinical outcomes.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.