amyotrophic lateral sclerosis
Conditions
Interventions
Treatment group:HS-03 injection treatment
Sponsors
Hangzhou First People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: (1) Age 18-70 years old, 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 screening = 4 years; (4) Before admission,ALSFRS-R scores were all = 2 points; (5) ALSFRS-R decreased by 1-4 points (=1 and =4) within 3 months of the screening period; (6) Patients need to sign an informed consent form.
Exclusion criteria
Exclusion criteria: (1) Other neurological diseases similar to ALS symptoms or affecting the evaluation of drug effectiveness, such as cervical spondylosis, lumbar spondylosis, dementia, etc.; (2) Patients with other autoimmune diseases, such as multiple sclerosis, polymyositis, myasthenia gravis, Guillain Barre syndrome, ankylosing spondylitis, rheumatoid arthritis, systemic lupus erythematosus, vitiligo, etc.; (3) 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.; (5) Screening period, acute myocardial infarction or interventional treatment in the past 6 months, heart failure patients (III-IV according to NYHA classification ); (6)Patients with severe pulmonary insufficiency such as COPD and pulmonary fibrosis. (7)Patients with other serious primary diseases of the nervous system, heart, lungs, hematopoietic system or endocrine system and psychosis; (8)Suspected or indeed have a history of alcohol or drug abuse; (9)Patients with SOD1 gene mutation; (10) 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; (11) Have participated in other clinical trials within 30 days before screening, or are participating in other clinical trials; (12) 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;Inflammatory factors ;Oxidative stress level;Neurofilament light chain,NFL; | — |
Countries
China
Contacts
Public ContactWei Hu
Hangzhou First People's Hospital
Outcome results
None listed