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Treatment of hUC-MSC for neuromyelitis optica spectrum disorder- A prospective multicenter randomized controlled study

Treatment of hUC-MSC for neuromyelitis optica spectrum disorder- A prospective multicenter randomized controlled study

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-INR-16008037
Enrollment
Unknown
Registered
2016-03-02
Start date
2016-06-01
Completion date
Unknown
Last updated
2020-03-16

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

Conditions

neuromyelitis optica spectrum disorder

Interventions

intervention group:regular drug treatment plus hUC-MSC
congtrol group:regular drug treatment plus placebo

Sponsors

Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: NMOSD; (6) Liver and kidney function, blood routine, urine routine and other biochemical tests are basically normal; that is, there is no severe liver and kidney disease (see exclusion criteria 4), the white blood cell count in blood routine is 3.0 × 109 / L 12 × 109 / L Hemoglobin (Hb) is not less than 80% of the lower limit of normal value, and platelets are not less than 100 × 10 ^ 9 / L; (7) blood coagulation function is normal; that is, TT, APTT, PT, FIB, TDP, and DD are within 2 times the normal high value; (8) Able to complete follow-up; (9) The patient or family member signs the informed consent;

Exclusion criteria

Exclusion criteria: (1) Abnormal expression or disturbance of consciousness and unstable vital signs; (2) abnormal thyroid function and other endocrine disorders, which cannot be controlled after treatment; (3) Patients with severe mental illness who cannot cooperate with clinical symptoms; (4) Patients with severe liver and kidney disease (liver function test> 2 times normal upper value, blood creatinine clearance estimated by Cockcroft-Gault equation <60 mL / min) and patients with severe systemic wasting disease; (5) gastrointestinal tract or other serious bleeding diseases within one month before screening; (6) History of allergy related to personal drugs; (7) A history of major surgery one week before enrollment; (8) pregnant or lactating women; (9) Patients with hepatitis B and C, HIV infection, syphilis infection, and history of cancer; (10) Suffer from other immune-related diseases and need to be treated with immunosuppressive agents, such as Sjogren's syndrome, systemic lupus erythematosus, etc .; (11) Others who cannot cooperate with clinical research.

Design outcomes

Primary

MeasureTime frame
Recurrent events of the clinical symptoms;

Secondary

MeasureTime frame
EDSS score;Number of lesions;

Countries

China

Contacts

Public ContactGuan Yangtai

Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University

yangtaiguan@sina.com+86 13386271865

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Mar 19, 2026