An observational study in Autoimmune Diseases of the Nervous System, Neuromyelitis Optica Spectrum Disorder and Multiple Sclerosis, sponsored by Tongji Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-29.
Sponsored by Tongji Hospital · Observational
Neurological autoimmune diseases are a group of disorders characterized by the abnormal immune response attacking the nervous system, including the brain, spinal cord and peripheral nerves. These diseases exhibit high heterogeneity, diverse clinical presentations, and are challenging to diagnose and manage due to a lack of effective treatments. In this study, the investigators will recruit eight kinds of autoimmune diseases of nervous system including Neuromyelitis Optica Spectrum Disorder (NMOSD), Myasthenia Gravis (MG), Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP), idiopathic inflammatory myopathy (IIM), and multiple sclerosis (MS), autoimmune encephalitis (AE), Myelin Oligodendrocyte Glycoprotein Antibody-Associated Disease (MOGAD). Through this study, the investigators aim to discover biomarkers with high sensitivity, specificity, and stability, which can support early diagnosis, disease monitoring, and personalized treatment for neurological autoimmune diseases, thereby improving the quality of life and prognosis for patients.
Autoimmune diseases of the nervous system are a type of disease in which the human immune system mistakenly attacks its own nervous system, causing damage to the structure and function of the nervous system. Its main pathogenic mechanism is that autoimmune cells, autoantibodies and other immune molecules directly or indirectly attack the nervous system. Autoimmune diseases of the nervous system can affect the central nervous system, peripheral nervous system and neuromuscular junction, leading to pathological changes such as neuronal or axonal damage, demyelination, and destruction of neuromuscular junction. Autoimmune diseases of the nervous system are relatively rare, with a wide range of damage and complex and diverse clinical manifestations. They have the characteristics of complexity of immune diseases and high mortality and disability of nervous system diseases. At present, the understanding of the disease is limited, and some diseases are difficult to diagnose. Globally, it is a major cause of disability in young and middle-aged people and can cause huge social and economic burdens. However, due to the lack of a series of relatively reliable prognostic predictors, it is impossible to carry out personalized immunotherapy to achieve the best therapeutic effect, and serious adverse events may occur. Proteomics, metabolomics, intestinal microorganisms and intestinal high-throughput targeted metabolomics, exosomes, miRNA sequencing, single-cell transcriptome sequencing and other detection methods and lymphocyte subsets have been hot topics in the study of various diseases in recent years. It has been found that abnormalities in the expression and function of certain genes, proteins, metabolites, miRNAs, intestinal flora and lymphocyte subsets are closely related to the occurrence and development of many diseases and the functional disability of patients, and have a good suggestive effect on prognosis judgment.
Patients with neurological autoimmune disease admission to Department of Neurology and Neurosurgery, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology from June 1, 2024 - May 31, 2034.
Exclusion Criteria:
clinical diagnosis with autoimmune disease of central nervous system
Diagnostic Test: biomaker levels
age- and sex-matched control individuals
Diagnostic Test: biomaker levels
this study will discover and validate novel biomarkers (including blood, feces, bone marrow and lymph nodes etc al) of various neurological autoimmune diseases
All-cause mortality
Death during the follow-up in every single reason
Time frame: 10 years
Autoimmune disease of any kind
Brain or spinal MRI scans will be used to detect the presence of any autoimmune disease, including multiple sclerosis, neuromyelitis optica spectrum disorder, acute disseminated encephalomyelitis, autoimmune encephalitis, Guillain-Barré syndrome, and myasthenia gravis.
Time frame: 10 years
Accumulated total active MRI lesions
the number of accumulate total active MRI lesions after CT103A infusion
Time frame: 10 years
Expanded Disability Status Scale (EDSS) score
EDSS and its associated functional system (FS) score provide a system for quantifying disability and monitoring changes in the level of disability over time. EDSS is a scale for assessing neurologic impairment in multiple sclerosis (MS). It consists of 7 FS (visual FS, brainstem FS, pyramidal FS, cerebellar FS, sensory FS, bowel and bladder FS, and cerebral FS) which are used to derive EDSS score ranging from 0 (normal neurological exam) to 10 (death from MS). A negative change from baseline indicates improvement. A participant was considered to have a worsening in overall EDSS score of at least 2 if baseline EDSS score was 0, or at least 1 point if baseline EDSS score is 1 to 5, or at least 0.5 point if baseline EDSS score is 5.5 or more.
Time frame: 10 years
Modified Rankin Scale
Modified Rankin Scale (mRS) is a profoundly valid and reliable measure of disability and is broadly utilized for assessing stroke outcomes and degree of disability. A favorable outcome was characterized as mRS ranging from zero up to two, while unfavorable outcome ranging for 3 up to 6.
Time frame: 10 years
Visual acuity
Corrected visual acuity is determine by Snellen E chart held at a distance of 5 meters. Higher score indicates better vision.
Time frame: 10 years
Quantitative Myasthenia Gravis Score (QMG)
Quantitative Myasthenia Gravis Score (QMG) range from 0 to 3. The normal person scored 0 and the higher score represent sever clinical symptom.
Time frame: 10 years
Myasthenia Gravis Activities if Daily Living (MG-ADL) Score
The MG-ADL is an eight-question survey of symptom severity, with each response graded from 0 (normal) to 3 (most severe). Two questions concern ocular, three oropharyngeal, one respiratory, and two extremity functions. Cumulative MG-ADL scores range from 0 to 24
Time frame: 10 years
Inflammatory Neuropathy Cause and Treatment (INCAT) Score
The INCAT score comprises two parts, the arm score and the leg score. Based on a patient's level of impairment in their arms and legs, each part is scored between 0 and 5 points, resulting in an INCAT total score between 0 and 10.
Time frame: 10 years
Medical Research Council (MRC) muscle function Score
The MRC score system for testing and grading of muscle function aims to provide a standardized and objective way to assess muscle function. It ranges from 0 to 5.
Time frame: 10 years
Manual Muscle Testing (MMT) Score
For MMT score, 16 muscle groups/ motions will be tested (not individual muscles). 14 of these are tested bilaterally. The score range from 0 to 10. A score of 10 is normal and a score of 0 is the worst.
Time frame: 10 years
36-item Short Form Generic Health Survey (SF-36) score
SF-36 will used to understand the health related quality-of -life of the subjects after CT103A infusion. The eight health concepts: limitations in physical activities because of health problems; limitations in social activities because of physical or emotional problems; limitations in usual role activities because of physical health problems; bodily pain; general mental health (psychological distress and well-being); limitations in usual role activities because of emotional problems; vitality (energy and fatigue); and general health perceptions will be searched. These outcomes will be grouped as physical component summary and mental component summary. The norm data is 0-100, the health related quality of life is increases as the scores are increased. The average score is 50.
Time frame: 10 years
EuroQol-five dimensions (EQ-SD) score
Health status is measured with the EuroQuality of Life Five Dimensions (EQ-5D) after CT103A infusion, which includes five dimensions and is used to evaluate the quality of life of sepsis survivors. They are mobility, self-care, usual activities, discomfort or pain and depression or anxiety. Levels are coded 1-5 and a total score is then generated. Results for the demographic measured will be displayed as a percentage value.
Time frame: 10 years
Visual analogue scale (VAS) pain score
usual visual analog scale (VAS) of pain is used to evaluate pain after CT103A infusion (line from 0: no pain to 10:worst pain)
Time frame: 10 years
Changes of concentration( pg/mL) of cytokines
such as ferritin, CRP, IL-6 and procalcitonin) will be analyzed
Time frame: 10 years
Profiling of immune cell subtypes
Changes in immune cells (including proportion of CD3+ T cells, CD3+CD4+ T cells and CD3+CD8+ T cells, ratio of CD4+ T/CD8+T) in blood, CSF and other immune organs will be analyzed through flow cytometry and single cell sequencing.
Time frame: 10 years
Plan to share: No
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