The Evaluation of the Effect of Mesenchymal Stem Cells on the Immune System of Patients With ALS

Exclusion Criteria

• •1. Pregnancy or breastfeeding
• •2. Tracheostomy
• •3. Ventilator dependence
• •4. Renal disease with creatinine \>2mg/dl
• •5. Liver disease with ALT, AST or GGTP 2-fold higher than upper normal limit
• •6. Positive test for HBV, HCV, HIV with NAT method
• •7. Positive tests for syphilis
• •8. Any other clinically significant abnormalities on laboratory evaluation
• •9. Any condition that would compromise ability of undergoing lumbar puncture
• •10. Active systemic disease
• •11. Autoimmune disease (Hashimoto disease under control is allowed)
• •12. Uncontrolled diabetes (HbA1c \> 8%)
• •13. Pulmonary disease that could affect interpretation of spirometry
• •14. Neurological concomitant disease
• •15. Unstable psychiatric concomitant disease
• •16. High risk of suicide
• •17. History of substance abuse within past year
• •18. History of malignancy, within the previous 5 years, including melanoma with exception of localized skin cancers
• •19. Any other clinically significant medical condition that can compromise patient's safety in the opinion of the investigator
• •20. Treatment with immunomodulatory drugs (for example immunoglobulins, corticosteroids or other immunosuppressant) in last 6 months
• •21. Participation in another clinical trial in last 6 months
• •22. Previous cellular therapy of any kind
• •23. Hypersensitivity to any component used in the cell culture
• •24. Nuchal rigidity and other signs of meningitis
• •25. Patients on chronic anticoagulation treatment (heparin/ warfarin/acenocoumarol/(N)OAC)