spinal cord injury at subacute stage
Conditions
Interventions
Transplantation of iPSC derived neural stem/progenitor cells between predetermined day after spinal cord injury
Sponsors
Nakamura Masaya
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Complete spinal cord injury (ASIA impairment scale A) at C3/4-Th10 level, within predetermined days after spinal cord injury at acquiring consent. 2) Possible to transplant cells between predetermined days after the injury. 3) Possible to be hospitalized first to Keio University Hospital after the transplantation, then to the Murayama Medical Center up to predetermined months after cell transplantation.Also able to visit Keio University Hospital up to predetermined weeks after cell transplant surgery. 4) 18 years old, or older. 5) Sufficient informed consent.
Exclusion criteria
Exclusion criteria: 1)Multiple or transection injury of spinal cord, or combined damage of dural membrane by preoperative MRI imaging 2)Past diseases Primary neurodegenerative diseases Unable to take MRI Intoxication Other diseases which make it difficult to comply with protocol treatment 3)Comorbidity Major respiratory complications. Trauma, or organ injuries to make the assessments difficult Other severe medical complications including heart failure, diabetes mellitus, hypertension, interstitial pneumonia, renal failure, autoimmune disease, and cancer. Active infectious diseases that contraindicate surgery. 4)Significant abnormality in clinical laboratory values 5)Allergy to immunosuppressant 6)Combination therapy Participation in another clinical trial Medication with predetermined drugs 7)Pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety | — |
Secondary
| Measure | Time frame |
|---|---|
| Effectiveness | — |
Countries
Japan
Contacts
Public ContactTsuneo Kozuki
Keio University School of Medicine
Outcome results
None listed