• Patient provides written informed consent, informed consent signature collection prior to any study procedure (patient has good acceptance and understanding of the informed consent);

• Definite, probable diagnosis according to the revised El Escorial criteria;

• Age: 18-65 years;

• FVC \>70%;

• Onset ≤ 24 months;

• 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;

• 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;

• 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;

• Patient is medically able to tolerate transient immunosuppression regimen;

⁃ Presence of a willing and able caregiver who understands the need to attend all follow-up visits, even if mobility declines.