Regenerative medicine for spinal cord injury at subacute stage using human induced pluripotent stem cell-derived neural stem/progenitor cells

Recruitment & Eligibility

Status: Complete: follow-up continuing

Sex: All

Target Recruitment: 4

Inclusion Criteria

Not provided

Exclusion Criteria

1)Condition of spinal cord injury Multiple or transection injury of spinal cord, or combined damage of dural membrane by preoperative MRI imaging. 2)Past history, comorbidity History of spinal cord injury, or history or coexistence of abnormalities in the spinal cord or intrathecal space (tumors, inflammation, hemorrhage, etc.). Difficult or unable to capture MRI image (such as patients with the pacemaker in the heart). History or coexistence of intoxication of alcohol or other drugs. 3)Comorbidity Major respiratory complications which 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 WBC<3.5x10^3/mm3, Neutrophil (%)>90, Platelets<1.5x10^5/mm3, Hb<10.0g/dL, PT-INR>1.2 (without the patients with anticoagulant), APTT>41sec(without the patients with anticoagulant), creatinine>male1.1mg/dL, female 0.8mg/dL, Hepatic transferase (AST or ALT)>70 IU/L, total bililbin>1.0mg/dL. *The border data can be included (insufficient display of inequality sign due to the system problem) 5)History of Allergy Allergy to FK506. Allergy to ARTCEREB irrigation and perfusion solution for cerebrospinal surgery. 6)Combination therapy Cyclosporine, Bosentan, Pottasium-sparing diuretics at the time of consent. Use of other investigational new drug within 1 months from the time of consent. Use of steroid after spinal cord injury. 7)Pregnancy Women who are pregnant, lactating, or may be pregnant or are planning pregnancy during clinical study participation period. Men who want partner's pregnancy during clinical study participation period. 8)Other patients who are deemed inappropriate by researcher.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Safety: Check adverse events occurred from the time of cell transplantation to the end of 1-year observation period

Secondary Outcome Measures

Name	Time	Method
Effectiveness

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