Regulatory T Cells for Amyotrophic Lateral Sclerosis

Prior treatment

• Antiplatelet or anticoagulant therapy within the 14 days prior to Day 1 or anticipated use during the study, including but not limited to daily aspirin including low dose aspirin (defined as ≤ 150 mg/day), clopidogrel, dipyridamole, warfarin, dabigatran, rivaroxaban and apixaban
• Concurrent participation in any other interventional clinical study

Other illness

• Uncontrolled infection, not responding to appropriate antimicrobial agents after seven days of therapy. The Protocol medical monitor is the final arbiter of eligibility.
• Have any other conditions, which, in the opinion of the Investigator would make the subject unsuitable for inclusion, or could interfere with the subject participating in or completing the study
• Treatment of cancer in the last 5 years (except in situ carcinoma of the cervix or basal cell carcinoma)

Lab values

• Clinically significant low platelet count (defined as \< 100,000/mm3), coagulation tests, or laboratory abnormalities that would render a subject unsuitable for inclusion
• Treatment with another investigational drug, biological agent, or device, including, but not limited to sodium phenylbutyrate, within 1 month of Screening, or 5 half-lives of investigational agent, whichever is longer

Other

• Unwillingness to comply with study procedures, including follow-up, as specified by this protocol, or unwillingness to cooperate fully with the Investigator
• Female subjects who are pregnant or currently breastfeeding
• Other unspecified reasons that, in the opinion of the Investigator or Sponsor, make the subject unsuitable for enrollment.

• Ability of the subject or his/her legally authorized representative to provide informed consent.
• Adult ALS subjects (≥18 years of age)
• Diagnosis of ALS, according to the Revised El Escorial Criteria for ALS
• Subjects with disease onset ≤ 5 years
• Upright (sitting position) Slow Vital Capacity (SVC) as adjusted for sex, age and height ≥ 50% predicted
• Subjects must have documented ALSFRSR score of 36-45 at baseline.
• Subjects taking concomitant Riluzole or Edaravone or Albrioza at study entry must be on a stable dose for ≥ 30 days prior to the first dose of study treatment (Day 1).
• Screening values of coagulation parameters including platelet count, international normalized ratio (INR), prothrombin time (PT), and activated partial thromboplastin time (APTT) should be within normal ranges.
• Agree to practice highly effective contraception during the study and continue contraception for 90 days after their last dose of study treatment.