Novabio therapeutics Co., Ltd.

Primary objective: To evaluate the safety and tolerability of NP001 cell injection in the treatment of ALS subjects (timeframe: 6 months after last dose (SAD)/12 months (MAD/Phase IIa)). Secondary objectives: 1. Evaluate the effect of NP001 cell injection on disease status (timeframe: until 6 months after the last dose (SAD)/12 months (MAD/Phase IIa)); 2. Evaluate the effect of NP001 cell injection on overall survival (OS) in ALS subjects through survival follow-up (timeframe: until the subject meets the study exit criteria, the study is completed/early terminated, or the survival follow-up period reaches 2 years [calculated from the end of the safety follow-up period]); 3. Evaluate the effect of NP001 cell injection on immune system parameters in the blood (timeframe: until 6 months after the last dose (SAD)/12 months (MAD/Phase IIa)); 4. Evaluate the effect of NP001 cell injection on immune system parameters in the cerebrospinal fluid (timeframe: until 6 months after the last dose (SAD)/12 months (MAD/Phase IIa)). Note: 1 month is calculated as 28 days.