Safety and Efficacy of Intravenous Administration of SHED-CM for ALS

Inclusion Criteria:

Patients who meet the following inclusion criteria (1) to (6) at the time of Informed consent

1. Patients who have provided written informed consent to participate in the study.

2. Patients who are at least 20 years of age at the time of obtaining informed consent.

3. Patients diagnosed with isolated or familial ALS and diagnosed as definite, theprobable, or the probable laboratory-supported by updated Awaji criteria.

4. Patients with severity 1 or 2 on ALS severity criteria.

5. Outpatients.

6. Patients residing in Japan who can communicate in Japanese.

Exclusion Criteria:

Patients who do not meet any of the exclusion criteria (1) to (15) at the time of Informed consent

1. Patients with a tracheostomy

2. Patients with a history of non-invasive respiratory support

3. Patients with a percent FVC of 60 or less

4. Patients with chronic obstructive pulmonary disease (COPD)

5. Patients newly treated with edaravone or riluzole (oral) within 4 weeks prior toInformed consent

6. Patients receiving HAL medical leg type treatment

7. Patients receiving intravenous edaravone

8. Patients with cognitive impairment

9. Pregnant women or patients who may be pregnant

10. Patients with serious respiratory, cardiovascular, hepatic, or renal disease

11. Patients with malignant tumors

12. Patients with uncontrolled infection

13. Patients who have participated in other clinical trials within 12 weeks prior toobtaining consent

14. Patients with a history of drug allergy or severe allergic disease (e.g.,anaphylactic shock) or concomitant history

15. Patients who are deemed inappropriate to participate in the study by the principalinvestigator or research coordinator.