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

Exclusion Criteria

• •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 to Informed 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 to obtaining 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 principal investigator or research coordinator.