This study is non-randomized, multicenter, confirmatory study by intrathecal administration of KP-100IT, code of HGF (Hepatocyte Growth Factor ) formulation for intrathecal injection, in subjects with acute spinal cord injury.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
25
Intrathecal injection of 0.6 mg HGF starting at 72 hours since the injury and repeating weekly 5 times
Spinal Injuries Center
Iizuka, Fukuoka, Japan
RECRUITINGHokkaido Spinal Cord Injury Center
Bibai, Hokkaido, Japan
RECRUITINGJapanese Red Cross Kobe Hospital
Kobe, Hyōgo, Japan
Percentage of subjects with an improvement of at least two AIS (American Spinal Injury Association) grade, A to C/D, at 24 weeks after administration
Time frame: 24 weeks
Time course of ASIA motor score (total/ upper extremity / lower upper extremity)
Time frame: up to 24weeks
Time course of ASIA sensory score
Time frame: up to 24weeks
Time course of AIS classification
Time frame: up to 24weeks
Time course of modified Frankel classification
Time frame: up to 24weeks
Time course of neurological level of injury
Time frame: up to 24weeks
Percentage of subjects improving by at least 10 points on the ASIA motor score at 12 weeks and 24 weeks after administration relative to before study drug administration
Time frame: 12 weeks and 24 weeks
Time courses of plasma concentration and cerebrospinal fluid concentration of KP-100IT after intrathecal administration
Time frame: up to 24weeks
Evaluation of adverse events
Time frame: up to 24weeks
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Aijinkai Rehabilitation Hospital
Takatsuki, Osaka, Japan
RECRUITINGMurayama Medical Center
Musashimurayama, Tokyo, Japan
RECRUITING