Acute spinal cord injury
Conditions
Interventions
filgrastim 400ug/m2/day * 5day
placebo 400ug/m2/day * 5day
Sponsors
Chiba University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) AIS Grade is B or C at screening (2) AIS Grade is B or C at re-assessment of neurological status 48 hours (plus-minus 4 hours) after the injury (3) Neurological level of injury is between C4 and C7 (4) Age betweem 16-85 (5) Patients who give informed consent to participate in the present trial (6) Patients who can visit 1 month, 3 months, 6 months, and 12 months after administration
Exclusion criteria
Exclusion criteria: (1) Allergy to filgrastim. (2) Hematologic malignancy or its previous history (3) Malignant disease under treatment (4) invasive treatment for myocardial infarction or angina pectoris within 6 months (5) previous history of rombosis (6) splenomegaly. (7) consciousness disorder. (8) Patients who are pregnant women, are willing to become pregnant in study period or are lactation. (9) Neurological disorder which can affect neurological evaluation in the present trial (10) Patients who receive filgrastim or methylprednisolone sodium succinate after the injury (11) Patients who are expected to have rapid worsening of symptoms during the trial period (12) Patients with serious complications (13) Patients who can not start the rehabilitation in early by complications (14) Patients with advanced dementia or mental illness (15) Patients who have unstable physical status by multiple trauma or organ damage (16) Patients who have fracture of extremities, the spine, or the other parts which can affect neurological evaluation in the present trial (17) Patients who are participating in other trials, or received other study drugs within 12 weeks (18) In addition, the patient whom investigator judged to be unsuitable as a patient.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Transition of motor paralysis(3 months after study drug administration) | — |
Secondary
| Measure | Time frame |
|---|---|
| (Efficacy) Change in motor paralysis Change in sensory paralysisThe degree of dysfunction associated with paralysis The proportion of responder to the treatment The level of neurological injury SCIM, EQ-5D (Safety) Frequency of adverse events | — |
Countries
Japan
Contacts
Public ContactTadami Fujiwara
Chiba University Hospital Chiba Clinical Research Center
Outcome results
None listed