Table 2.

Inclusion and exclusion criteria of the clinical study.

Eligibility inclusion criteria
1)	Within 24 days after spinal cord injury with the injury level between the third/fourth cervical vertebrae and the tenth thoracic vertebra, with paralysis of AIS grade A, at the time of consent.
2)	Able to transplant hiPSC-NS/PCs at 14–28 days after SCI.
3)	Patient able to be hospitalized at Keio University Hospital in the acute period after cell transplantation surgery, followed by Murayama Medical Hospital at least until the sixth month after transplantation. Patient also able to visit Keio University Hospital for up to 52 weeks after cell transplantation.
4)	Patient 18 years or older at the time of consent.
5)	Written informed consent voluntarily provided by the patient. When the patient is unable to provide a signature, written proof of the patient's agreement by witness of an adult relative. When the patient is younger than 20 years, written proof of the agreement of an adult relative, in addition to the patient's consent.
Eligibility exclusion criteria
1)	The state of the injured spinal cord.
	Patients with multiple injuries, transection injury, or injury with a dural tear on preoperative MRI.
2)	Past history, comorbidity
	History of spinal cord injury, or history or coexistence of abnormalities in the spinal cord or intrathecal space (a spinal cord tumor, meningitis, spinal subarachnoid hemorrhage, etc.).
	Difficult or impossible to capture MRI images (e.g., patients with a pacemaker in the heart).
	History or coexistence of intoxication due to alcohol or other drugs.
3)	Comorbidity
	Major respiratory complications that require tracheal intubation, tracheostomy, or ventilation.
	Trauma or organ injuries that interfere with safety/efficacy evaluation.
	Other severe or uncontrolled medical complications including heart failure, diabetes mellitus, hypertension, interstitial pneumonia, renal failure, autoimmune disease, cancer, and mental illness.
	Active infection that becomes a contraindication for surgery.
	Dementia or high risk of dementia.
4)	Laboratory data
	White blood cells ≤3.5 × 103/mm3, neutrophils ≥90%, platelets ≤1.5 × 105/mm3, hemoglobin ≤10.0 g/dL, PT-INR ≥ 1.2 (excluding patients taking anticoagulants), APTT ≥41 s (excluding patients taking anticoagulants), creatinine ≥1.1 mg/dL in males and 0.8 mg/dL in females, hepatic transferase (AST or ALT) ≥ 70 IU/L, and total bilirubin ≥1.0 mg/dL.
5)	History of allergy
	Allergy to FK506.
	Allergy to ARTCEREB irrigation and perfusion solution for cerebrospinal surgery.
6)	Combination therapy
	Cyclosporine, bosentan, and potassium-sparing diuretics at the time of consent.
	Use of another investigational new drug within 1 month from the time of consent.
	Use of steroids after spinal cord injury.
7)	Pregnancy
	Women who are pregnant, lactating, or may be pregnant or are planning to become pregnant during the participation period of the clinical study.
	Men whose partners will be or plan to become pregnant during the participation period of the clinical study.
8)	Other patients who are deemed inappropriate by researchers.

Abbreviations:AIS, American Spinal Cord Injury Association Impairment Scale; hiPSC-NS/PC, human induced pluripotent stem cell-derived neural stem/progenitor cell; SCI, spinal cord injury; MRI, magnetic resonance imaging.