Amyotrophic lateral sclerosis
Conditions
Sponsors
Boao Evergrande International Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-70 years, gender is not limited; 2. The diagnosis meets the ALS confirmed and proposed diagnosis in the ALS2020 diagnostic standard (Gold Coast standard); 3. The duration of the disease from the onset of the subject to the time of admission = 2 points, and the respiratory function items were >= 3 points; 5. ALSFRS-R decreased by 1-4 points (>= 1 and = 70%; 7. Patients need to sign an informed consent form.
Exclusion criteria
Exclusion criteria: 1. Severe renal insufficiency: creatinine clearance 3 times the upper limit of normal value, or other known liver diseases such as acute and chronic active hepatitis, cirrhosis, etc.; 3. Screening period, acute myocardial infarction or interventional treatment in the past 6 months, heart failure patients (III-IV according to NYHA classification ); 4. Patients with other serious primary diseases of the nervous system, heart, lungs, hematopoietic system or endocrine system and psychosis; 5. Suspected or indeed have a history of alcohol or drug abuse; 6. Pregnant or lactating women, subjects of childbearing age (including male subjects with heterosexual sex and their female partners with reproductive potential) who have pregnancy plans or are unwilling to take effective contraception within 3 months from the beginning of screening to the cessation of the drug; 7. Have participated in other clinical trials within 30 days before screening, or are participating in other clinical trials; 8. The researchers believe that it is not suitable to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety evaluation index;efficacy index; | — |
Secondary
| Measure | Time frame |
|---|---|
| Immunological index; | — |
Countries
China
Contacts
Public ContactZhonghua Zhou
Outcome results
None listed