臨床研究等提出・公開システム

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

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

Matsumoto Morio

Nakamura Masaya

Keio University School of Medicine

35 Shinanomachi, Shinjuku-ku Tokyo

okanolab2020sci@gmail.com

Kozuki Tsuneo

Keio University School of Medicine

35 Shinanomachi, Shinjuku-ku Tokyo

+81-3-5363-3747

okanolab2020sci@gmail.com

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

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.

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

Both

spinal cord injury at subacute stage

Transplantation of iPSC derived neural stem/progenitor cells between predetermined day after spinal cord injury

Safety

Effectiveness

Not Recruiting

+81-3-5363-3503

Nov. 27, 2018

Yes

Data on the safety and efficacy of this clinical study will be published in the database of the Japanese Society for Regenerative Medicine (National RegenerativeMedicine Database:NRMD) under the responsibility of the study manager.

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