Spinal Cord Injuries
Conditions
Keywords
Hepatocyte Growth Factor, HGF, KP-100IT, Intrathecal injection
Brief summary
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.
Interventions
DRUGKP-100IT
DRUGPlacebo
Sponsors
Kringle Pharma, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Age equal to or greater than 18 years and equal to or less than 75 years * Cervical spinal cord injury, and Grade A, B1 or B2 in the modified Frankel Scale at 72 hours since the injury * Subjects able to provide written informed concent, which may require a relative to sign if arm/hand function of the subject is compromised
Exclusion criteria
* Spinal cord injury at C1-C2 0r C2-C3 level * Patients not to able to start rehabilitation within a week by setup of respirator or other reason * First dose of the study drug will not be given within 78 hours since the injury * History of spinal cord injury or abnormality in spinal cavity. Or current considerable meningeal damage * Outcome assessment will not be conducted adequately through damage on injuries other than the injury * High-dose steroid therapy within 30 days before the entry * Patients who have diseases such as serious liver disorder, renal disorder, hear disease, blood dyscrasia, metabolism disorder and infections * History of malignant tumor * Patients who participated in other clinical study within 30 days before the entry * Patients who have allergies to drug scheduled to be used in the study * Administration of the study drug to the area of spinal cord injury is not appropriate for example by intrathecal infections or intrathecal tumor * Patients not able to understand informed consent properly * Patients who are nursing or may be pregnant * Investigator considers that the patient is not appropriate for participating in the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number and degree of adverse events | 24 weeks | Adverse events will be judged by general condition, vital sign, electrocardiogram, MRI, blood chemistry, hematology, urinalysis, cerebrospinal fluid examination, and antibody formation |
| Change of ASIA (American Spinal Injury Association) motor score from baseline at 24 weeks | 24 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Time-dependent change of ASIA sensory score from baseline | 24 weeks |
| Change of ASIA motor score from baseline at 12 weeks | 12 weeks |
| Time-dependent change of P-100 concentration in plasma and cerebrospinal fluid | 6 weeks |
| Time-dependent grade change of modified Frankel scale from baseline | 24 weeks |
| Time-dependent change of ASIA motor score from baseline | 24 weeks |
Countries
Japan
Outcome results
None listed