A Study of STRO4 in Patients Amyotrophic Lateral Sclerosis (ALS)

Criteria the registry did not label

• Inclusion:
• "Definite" or "Probable" ALS according to the Revised El Escorial criteria (Airlie House)
• ALS severity grade 1 or 2 according to the Japan ALS severity classification.
• ALSFRS-R scores of 2 or more for all items, with scores of 4 for all breathing- related items (i.e., dyspnea, orthopnea, respiratory insufficiency).
• Within 2 years of ALS onset.
• %FVC of 80% or more.
• Aged 18 to ≤75 years at the time of informed consent.
  • Exclusion:
• Current Viral Infection (e.g. HBV, HCV, HIV, HTLV-1, HPVB19, syphilis, COVID- 19).
• Current low blood cell counts
• History of cancer, congenital malformations, or chromosomal abnormalities
• History of allergy to penicillin or streptomycin, or other serious allergies.
• Current poor medical condition, due to endocrine disease, metabolic disease, immune disease, blood disease, psychiatric disorders, neurological diseases, cardiovascular diseases, respiratory diseases, gastrointestinal diseases, musculoskeletal or connective tissue diseases, renal or urogenital diseases.
• History of intracranial lesions, or stenosis, dissection or severe atherosclerotic disease of a blood vessel in the head or neck.
• Current uncontrolled hypertension.
• Prior treatment with a cell or gene therapy.
• Currently participating in any other clinical trial.
• Women who are pregnant, breastfeeding, or plan to become pregnant during study participation
• Men with plan for their partner to become pregnant during study participation.