Clinical Research Directory

Inclusion Criteria: 1. 18-80 years old; 2. Confirmed or possible familial or sporadic ALS diagnosed according to the revised El Escorial criteria; 3. 6 months ≤disease duration ≤ 3 years, (onset time is defined as the time of the first occurrence of myasthenia); 4. Forced vital capacity (FVC) ≥ 85% of predicted value (based on gender, height and age); 5. Informed consent signed. Exclusion Criteria: 1. Patients undergoing endotracheal intubation, non-invasive or mechanical ventilation; 2. Patients with diaphragmatic pacemakers; 3. Allergy to any component of the investigational medication, or any other allergic history that researchers deem necessary to be vigilant about; 4. Local skin infection or other suspicious signs of infection at the injection site; 5. Known hemorrhagic tendency (including but not limited to: platelet count \<100×109/ L; on therapy of heparin, activated partial thromboplastin time (APTT) ≥35s; on therapy of warfarin, international normalized ratio (INR) \>1.7; on therapy of novel oral anticoagulants; with direct thrombin or factor Xa inhibitor; accompanied with coagulopathy such as hemophilia); 6. Severe cardiac insufficiency before randomization (comply with New York College of Cardiology (NYHA) Cardiac Function Class III, IV); 7. Suffering from infectious diseases: hepatitis, tuberculosis, acquired immunodeficiency syndrome, etc; 8. Psychiatric disorders diagnosed according to Diagnostic and Statistical Manual of Mental Disorders (DSM-V) diagnostic criteria; or with suicidal intentions; 9. Women/men with desire to conceive during the experiment, and patients with pregnancy and lactation; 10. Difficulty in verbal communication, inability to communicate, understand or follow instructions, inability to cooperate with treatment and evaluation; 11. Combining with history of alcohol and drug abuse; 12. Unable to cooperate in follow-up due to geographical or other reasons; 13. Patients participated in other clinical trials or used other biologics, drugs, or devices under study.