Neural Stem Cell Treatment for Amyotrophic Lateral Sclerosis (STEMALS)

Inclusion Criteria: 1. Patient provides written informed consent, informed consent signature collection prior to any study procedure (patient has good acceptance and understanding of the informed consent); 2. Definite, probable diagnosis according to the revised El Escorial criteria; 3. Age: 18-65 years; 4. FVC \>70%; 5. Onset ≤ 24 months; 6. Patients with an ALSFRS-R score of at least 26; overall, including a score of at least 2 on each of the 1-9 ALSFRS-R individual component items and of at least 3 of the 10-12 individual components items; 7. Evidence of fast progression of the disease. We exclude slow progressors at the time of screening defined as Patient with an ALSFRS-R total score progression between onset of the disease and screening of \< 0.3 per month. We document the fast progression of the disease defined as ALSFRS-R total score decrease of ≥ 1 point per month during a 12 week run-in period between screening and randomization; 8. Patient should be on a stable dose of Riluzole for \> 30 days from pre-screening visit or not taking riluzole at all, nor plan to begin riluzole during the study period; 9. Patient is medically able to tolerate transient immunosuppression regimen; 10. Presence of a willing and able caregiver who understands the need to attend all follow-up visits, even if mobility declines. Exclusion Criteria: 1. Psychiatric disease or other neurological diseases different from ALS; 2. Evidence of any concurrent illness or treatments limiting the safety to participate or any condition that the neurosurgeon feels may pose complications for the surgery; 3. Cancer within the previous 10 years; 4. Immunosuppressive therapy within 12 weeks of screening; active autoimmune disease or infection (including hepatitis B, hepatitis C, or HIV); 5. Cognitive impairment; 6. Contraindications to perform MRI scans, CSF withdrawal and Skin biopsy; 7. Patient unable to understand informed consent form; 8. Pregnancy and breast feeding; 9. Patient has been treated previously with any stem cell or somatic cells therapy; 10. Patient has participated in another clinical treatment trial or received other experimental medications outside of a clinical trial within 1 month prior to start of this study.