Peripheral single-cell immune landscape of relapsing neuromyelitis optica spectrum disorder during B cell depletion therapy

Analyzing immune responses in relapsing neuromyelitis optica spectrum disorder during B cell depletion therapy using single-cell sequencing

Status

Recruiting

Phases

Early Phase 1

Study type

Observational

Source

ChiCTR

Registry ID

ChiCTR2400092776

Enrollment

Unknown

Registered

2024-11-22

Start date

2023-09-26

Completion date

Unknown

Last updated

2024-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

neuromyelitis optica spectrum disorder(NMOSD)

Interventions

healthy control:None

Patients without relapse after B-cell depletion therapy:None

Patients experiencing relapse after B-cell depletion therapy:None

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1)Patients without relapse during B lymphocyte depletion therapy: 1. aged 18-75 years at the time of signing the informed consent form; 2. met the 2015 International Panel for NMO Diagnosis (IPND) diagnostic criteria for AQP4-IgG-seropositivity; 3. no relapse during B lymphocyte depletion therapy; 4. did not have severe cardiovascular, cerebrovascular, liver, kidney, or haematopoietic system lesions; 5. EDSS <= 7.5; 6. signed a written informed consent form voluntarily. 2)Patients with relapse during B lymphocyte depletion therapy: 1. aged 18-75 years at the time of signing the informed consent form; 2. met the 2015 International Panel for NMO Diagnosis (IPND) diagnostic criteria for AQP4-IgG-seropositivity; 3. relapse during B lymphocyte depletion therapy and in acute or subacute stage. Continues to receive this therapy after relapse to prevent relapse; 4. did not have severe cardiovascular, cerebrovascular, liver, kidney, or haematopoietic system lesions; 5. EDSS <= 7.5 before relapse; 6. signed a written informed consent form voluntarily.

Exclusion criteria

Exclusion criteria: 1: Individuals aged below 18 years or above 75 years 2: Individuals with significant comorbidities such as cardiovascular, cerebrovascular, hepatic, renal, hematopoietic disorders, and diabetes 3: Individuals with a recent medical history of severe or recurrent infections 4: Individuals concurrently diagnosed with neoplastic conditions 5: Primary or secondary immunodeficiency disorders 6: Individuals of reproductive age who have received a positive urinary pregnancy test result, lactating individuals, and those who have recently expressed intentions to conceive 7: Individuals with severe cardiovascular and respiratory conditions or individuals at risk of complications involving vital organs such as the heart and lungs 8: Individuals who exhibit an inability to cooperate.

Design outcomes

Primary

Measure	Time frame
whether patients with NMOSD relapse during B lymphocyte depletion therapy;	—

Secondary

Measure	Time frame
B and T (NKT) lymphocytes, natural killer (NK) cells, and myeloid cells (neutrophils, monocytes); Expanded Disability Status Scale;NFKB1, ICAM1, etc.;	—

Countries

China

Contacts

Public ContactYanning Huang

The First Affiliated Hospital of Guangxi Medical University

huangyn02@126.com+86 157 7716 0632

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026