Clinical Study of Regulatory T Cells (Tregs) in the Treatment of Neurodegenerative Diseases

Inclusion Criteria: \- Patients must meet all of the following criteria to be eligible for enrollment in this study: 1. Male or female patients aged 18 to 70 years; 2. According to current international diagnostic criteria: ALS: defined by the Gold Coast Diagnostic Criteria (Shefner, 2020) as having a diagnosis of sporadic or familial amyotrophic lateral sclerosis (ALS), diagnosed as a probable, probable, or definite patient with laboratory support according to the World Federation of Neurology El Escorial criteria; 3. If there is a stable dose for more than one month prior to study entry. For example, patients with ALS can continue treatment with riluzole (Rilutek®) and/or edaravone (Radicava®); 4. Patients must have \> two weeks after the end of major surgery and after the completion of participation in other research trials; 5. Patients must have recovered from clinical toxicity (CTCAE \[5th Edition\] toxicity values have resolved to \< 2); 6. Serum creatinine less than or equal to 2.0 mg/dL; 7. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \< 3 x upper limit of normal; 8. Bilirubin \< 1.5 (except Gilbert's disease); 9. Lung slow vital capacity (SVC) \> 70% of predicted normal; 10. No history of abnormal bleeding tendency; 11. Informed consent must be obtained prior to performing any study-related procedures that are not part of standard medical care, with the understanding that the participant may withdraw from the study without influence for the future medical care. Exclusion Criteria: \- Subjects with any of the following cannot be enrolled in this study: 1. uncontrolled infection; 2. \< 3 drugs do not adequately control hypertension; 3. Documented history of pulmonary embolism within 6 months of enrollment; 4. Clinically significant cardiology, defined as: myocardial infarction, NYHA-graded class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmia, or ECG evidence of acute ischemia or abnormal conduction system within 6 months prior to enrollment; 5. Patients with a history of coronary artery bypass grafting or angioplasty will be evaluated by cardiology and considered on a case-by-case basis; 6. Seropositive for HIV, hepatitis B or hepatitis C; 7. Pregnant or lactating patients; 8. Patients of childbearing potential or males with partners of childbearing potential who are unwilling to use contraception; 9. Participation in any other interventional study; 10. Treatment with another investigational drug, biologic, or device within 30 days or 5 half-lives (whichever is longer) of the screening period. Patient participation in observational/non-interventional clinical studies will be discussed with the Medical Monitor; 11. Prior treatment with ALS gene or cell therapy; 12. History of clinically significant tumor, liver or kidney disease, or other uncontrolled disease; 13. presence of a feeding tube; 14. Current use of antipsychotics, antiepileptic drugs (except benzodiazepines, gabapentin, pre-Bahrain) or class 1 (e.g., flecainide) or class 3 (e.g., amiodarone) antiarrhythmic drugs; 15. Subjects who, in the opinion of the investigator, are at significant risk of suicide; 16. Other conditions that the investigator considers unsuitable for enrollment.