This study is randomized, double-blind, placebo-controlled Phase I/II study designed to evaluate safety and efficacy of KP-100IT, code of Hepatocyte Growth Factor (HGF) formulation for intrathecal injection, as a treatment for acute spinal cord injury. The study is conducted at two clinical sites in Japan.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
45
Spinal Injuries Center
Iizuka, Fukuoka, Japan
Hokkaido Chuo Rosai Hospital Sekison Center
Bibai, Hokkaido, Japan
Number and degree of adverse events
Adverse events will be judged by general condition, vital sign, electrocardiogram, MRI, blood chemistry, hematology, urinalysis, cerebrospinal fluid examination, and antibody formation
Time frame: 24 weeks
Change of ASIA (American Spinal Injury Association) motor score from baseline at 24 weeks
Time frame: 24 weeks
Change of ASIA motor score from baseline at 12 weeks
Time frame: 12 weeks
Time-dependent change of ASIA motor score from baseline
Time frame: 24 weeks
Time-dependent change of ASIA sensory score from baseline
Time frame: 24 weeks
Time-dependent grade change of modified Frankel scale from baseline
Time frame: 24 weeks
Time-dependent change of P-100 concentration in plasma and cerebrospinal fluid
Time frame: 6 weeks
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