Inclusion Criteria:
1. Age 18 years or older.
2. Sporadic or familial ALS diagnosed as possible, laboratory-supported probable, probable, or definite as defined by revised El Escorial criteria (Appendix 1).
3. Subjects must not have taken riluzole for at least 30 days, or be on a stable dose of riluzole for at least 30 days (riluzole-naïve subjects are permitted in the study).
4. Capable of providing informed consent and following trial procedures.
5. Geographically accessible to the site.
6. Women must not be able to become pregnant (e.g. post-menopausal, surgically sterile, or using adequate birth control methods) for the duration of the study and three months after study completion. Adequate contraception includes: abstinence, hormonal contraception (oral contraception, implanted contraception, injected contraception or other hormonal (patch or contraceptive ring, for example) contraception), intrauterine device (IUD) in place for ≥ 3 months, barrier method in conjunction with spermicide, or another adequate method.
7. Subjects must agree not to take live attenuated vaccines (including seasonal flu vaccine) 30 days before blood collection.
8. Available autologous Tregs product with greater than or equal to 50% expression of CD4, CD25 and FoxP3 determined by flow-cytometry.
9. Subjects must have been previously evaluated and followed clinically by a neuromuscular specialist at Houston Methodist Neurological Institute
10. Normal Alanine aminotransferase level (ALT)
11. Normal Serum creatinine level
Exclusion Criteria:
1. Prior use of cells therapies
2. Concurrent use of other experimental ALS therapies
3. Pregnant or breastfeeding or planning to become pregnant or planning a partner's pregnancy.
4. Other unstable medical or psychiatric illness
5. Known immune deficiency or history of lymphoma or leukemia
6. History of lymphopenia.
7. History of acquired or inherited immune deficiency syndrome, including leukopenia.
8. History of severe untreated chronic obstructive sleep apnea.
9. FVC less than 50% predicted at screening.
10. Exposure to any other agent currently under investigation for the treatment of subjects with ALS (off-label use or investigational) within 30 days of the Baseline Visit.
11. The presence of unstable psychiatric disease, cognitive impairment, or dementia that would impair ability of the subject to provide informed consent, according to the PI's judgment, or a history of active substance abuse within the prior year.
12. Clinically significant history of cardiac, oncologic, hepatic, or renal dysfunction, or other medically significant illness.
13. The presence of any immunologic or autoimmune disease
14. Severe cardiac dysfunction defined clinically, or as a left ventricular ejection fraction less than 40% of predicted or abnormal EKG findings.
