Inclusion Criteria:  Males and females ages 18 to 70 years old, at the Screening Visit. Sporadic or familial ALS diagnosed patients fulfilling the El Escorial clinical criteria for definite. Capable of providing informed consent and willing and able to follow study procedures, including willingness to undergo multiple/repeated lumbar punctures. ALSFRS-R ≥15 at the Screening Visit.  Exclusion Criteria:  Patients with severe cognitive decline or inability to understand and sign the informed consent. Participation in another clinical trial within 1 year prior to start of the study Patients with active infections. Positive test for Hepatitis B, Hepatitis C, and/or HIV per laboratory evaluations at the screening visit. Any history of solid malignancy including any malignancy affecting the central nervous system within 5 years of the Screening Visit