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 adiagnosis of sporadic or familial amyotrophic lateral sclerosis (ALS), diagnosed asa probable, probable, or definite patient with laboratory support according to theWorld 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 thecompletion of participation in other research trials;

5. Patients must have recovered from clinical toxicity (CTCAE [5th Edition] toxicityvalues 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 upperlimit 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 proceduresthat are not part of standard medical care, with the understanding that theparticipant may withdraw from the study without influence for the future medicalcare.

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-gradedclass III or IV heart failure, uncontrolled angina, severe uncontrolled ventriculararrhythmia, or ECG evidence of acute ischemia or abnormal conduction system within 6months prior to enrollment;

5. Patients with a history of coronary artery bypass grafting or angioplasty will beevaluated 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 potentialwho 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 5half-lives (whichever is longer) of the screening period. Patient participation inobservational/non-interventional clinical studies will be discussed with the MedicalMonitor;

11. Prior treatment with ALS gene or cell therapy;

12. History of clinically significant tumor, liver or kidney disease, or otheruncontrolled 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 ofsuicide;

16. Other conditions that the investigator considers unsuitable for enrollment.