complete spinal cord injury at subacute stage
Conditions
Interventions
Transplantation of iPSC derived neural stem/progenitor cells between 14th to 28th day after spinal cord injury
Sponsors
Keio University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) 24 days within spinal cord injury with the injury level of between 3rd/4th cervical vertebrae to 10th thoracic vertebrae, with the paralysis of AIS grade A at the time of consent. 2) Able to get transplant of hiPSC-NS/PCs between 14 to 28 days after SCI. 3) Able to be hospitalized to Keio University Hospital in acute period after cell transplant surgery, afterwards to Murayama Medical Hospital at least till the 6th month after the transplantation. Also able to visit Keio University Hospital up to 52 weeks after cell transplantation. 4) 18 years or older at the time of consent. 5) Written informed consent with the patient's own voluntary will. When unable to sign by himself, written proof of the patient's agreement by witness of adult relative. When the patient is under 20 years, written proof of the agreement of substitute of adult relative, in addition to the patient's consent.
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety: Check adverse events occurred from the time of cell transplantation to the end of 1-year observation period | — |
Secondary
| Measure | Time frame |
|---|---|
| Effectiveness | — |
Countries
Japan
Contacts
Public ContactTsuneo Kozuki
Keio University School of Medicine Department of Physiology
Outcome results
None listed