Study to Investigate the Safety of the Transplantation (by Injection) of Human Glial Restricted Progenitor Cells (hGRPs; Q-Cells®) Into Subjects With Amyotrophic Lateral Sclerosis (ALS)

Exclusion Criteria

• •1. Subject in whom causes of neuromuscular weakness other than ALS have not been practically excluded.
• •2. Subject with a diagnosis of significant cognitive impairment, clinical dementia, or major psychiatric illness including psychosis, bipolar disease, major depression, as determined by the DSM-V.
• •3. Subject with a diagnosis of other neurodegenerative disease (e.g., Parkinson's disease, Alzheimer's disease).
• •4. Subject with a diagnosis of any medical condition that impairs nerve or muscle function (e.g., notable peripheral neuropathy, metabolic muscle disease).
• •5. Subject with a clinically significant history of unstable cardiac, pulmonary, renal, hepatic, endocrine, hematologic, or active malignancy or infectious disease or other medically significant illness, which, in the opinion of the Investigator, would preclude study participation.
• •6. Subject with a history of spine surgery or anatomic variation incompatible with route of administration (as determined by neurosurgeon).
• •7. Subject with severe cervical or lumbar stenosis, cord compression, or cervical or lumbar myelopathy.
• •8. Subject with abnormal flow voids on the surface of the spinal cord suggestive of arteriovenous malformation (AVM).
• •9. Subject demonstrating any evidence of CNS malignancy or CNS lesions as defined by imaging studies of the CNS (MRI of brain and spinal cord).
• •10. Subject having uncontrolled hypertension (Systolic BP\>180mmHg and/or Diastolic BP \>110mmHg) or having a history of thrombotic events or poorly controlled medical conditions that, in the opinion of the Investigator and/or surgeon, increase risk of surgery.
• •11. Subject who cannot undergo MRI examination because of the presence of a pacemaker, an implanted defibrillator or certain other implanted electronic or metallic devices, or who have been or might have been exposed to metal fragments, or any reason the subject cannot undergo an MRI routinely for the duration of the trial.
• •12. Subject with clinically significant abnormal clinical laboratory values, as determined by the Investigator during the Screening Period.
• •13. Subject who is immune compromised or who has a condition contraindicated to treatment with immunosuppression agents (e.g., tuberculosis, latent infection).
• •14. Subject with an aspartate aminotransferase (AST) or alanine aminotransferase (ALT) value \>3.0 times the upper limit of normal or creatinine \>1.5 times the upper limit of normal and/or eGFR \<50cc/min during the Screening Period.
• •15. Subject with a history of alcohol or drug abuse or dependence within 1 year of the first day of the Screening Period, per DSM-V criteria.
• •16. Subject unlikely to comply with study requirements, as determined by Investigator.
• •17. Subject who has been exposed to any other experimental agent (off-label use or investigational) within 30 days of the first day of the Screening Period. Biologic agents may need additional time for washout and will be evaluated by the Sponsor on a case-by-case basis.
• •18. Subject who has previously been administered stem cells.
• •19. Subject with pre-existing anti-human leukocyte antigen (HLA) class I or class II antibodies directed against the Q-Cells®, as determined by panel reactive antibody (PRA) assay during the Screening Period.
• •20. Subject with an allergy to Q-Cells® or any of its constituents (e.g., chicken eggs), or an allergy to any of the co-administered immunosuppressants or any of their excipients.
• •21. Subject with any medical condition or using concomitant medication that would contraindicate the use of tacrolimus, mycophenolate mofetil, or prednisone as determined by Investigator.
• •22. Subject with evidence of deep vein thrombosis (DVT) by venous ultrasound or any previous evidence of DVT.
• •23. Subject who, in the opinion of the Investigator, has taken or is taking concomitant medications, supplements, or other agents that may interfere with the safety evaluation of Q-Cells® or may affect the course of the subject's ALS progression.