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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| KP-100IT | Active Comparator | Intrathecal injection of 0.6 mg HGF starting at 72 hours since the injury and repeating weekly 5 times |
|
| Placebo | Placebo Comparator | Intrathecal injection of placebo starting at 72 hours since the injury and repeating weekly 5 times |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KP-100IT | Drug |
|
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 24 weeks |
| Change of ASIA (American Spinal Injury Association) motor score from baseline at 24 weeks | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change of ASIA motor score from baseline at 12 weeks | 12 weeks | |
| Time-dependent change of ASIA motor score from baseline | 24 weeks | |
| Time-dependent change of ASIA sensory score from baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Etsuro HASHIMURA | Kringle Pharma, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Spinal Injuries Center | Iizuka | Fukuoka | 820-8508 | Japan | ||
| Hokkaido Chuo Rosai Hospital Sekison Center |
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| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| C564265 | Deafness, Autosomal Recessive 39 |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
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| ID | Term |
|---|---|
| D017228 | Hepatocyte Growth Factor |
| ID | Term |
|---|---|
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
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| Drug |
|
| 24 weeks |
| Time-dependent grade change of modified Frankel scale from baseline | 24 weeks |
| Time-dependent change of P-100 concentration in plasma and cerebrospinal fluid | 6 weeks |
| Bibai |
| Hokkaido |
| 072-0015 |
| Japan |
| D014947 | Wounds and Injuries |
| D011506 | Proteins |
| D001685 | Biological Factors |