Traumatic spinal cord injury. Injury of spinal cord, level unspecified
Conditions
Interventions
Intervention 1: one ampoule of GCSF (filgrastim) 300µg , Dosage: 300 µg /day, Daily for 7 days, injected Subcutaneously. Intervention 2: Placebo contains 1cc of normal saline 0.9%. Seven ampules are
Sponsors
Vice Chancellor for research of Tehran University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria: 1-Patient age 18-60 year 2-Traumatic cause for spinal cord injury should be established 3- One to six month of disease duration 4-Incomplete SCI (AIS=B, C, D) 5- Surgery, decompression and fixation should have been correctly done and the spine should be stable 6-The lesion should be upper motor neuron 7- Rostrocaudal lesion length on MRI should be 20mm at most on T1 weighted sequences 8-The spinal cord should be adequately decompressed with acceptable vertebral alignment without disc herniation and deformity 9-The follow-up of the patient should be possible in the study period
Exclusion criteria
Exclusion criteria: Exclusion criteria: 1-Atrophy of the spinal cord on MRI and/or concomitant syringomyelia 2-Heterotopic ossification and/or joint contractures 3- Major complication such as pressure sore grade 3 and 4, urinary tract infection and sepsis, pneumonia, DVT, instrument failure,… 4-Co morbidity such as head trauma, fracture of upper and lower limbs leading to deformity 5-Coexisting systematic disease 6-Involvement by acute psychosis, established delusion, dementia of every type, mood disorders, severe obsession, are prohibited to enter the study 7-Abnormal CBC 8-History of hematological disorder (platelet disorder, bleeding diathesis, in the first degree relatives) 9-History of cardiovascular disorders like MI and/or arrhythmia 10-History of peptic ulcer disease 11-Pregnancy and lactation period 12- History of severe hypersensitivity to Ecoli derived proteins, or drug of this origin, or the drugs that increase neutrophil count (like lithium) 13-Adverse reactions to the study drug 14-Non-cooperation by the patient and request to leave the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Neurological changes (Sensory and Motor). Timepoint: Before intervention,1,3 and 6 months after intervention. Method of measurement: ASIA form. | — |
Secondary
| Measure | Time frame |
|---|---|
| Spinal Cord Independence Measure (SCIM) III score. Timepoint: Before intervention, 1,3 and 6 months after intervention. Method of measurement: SCIM III Questionaire.;Functional Rating Scale (FRS) score. Timepoint: Before intervention, 1,3 and 6 months after intervention. Method of measurement: FRS Questionaire. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactDr Nazi Derakhshanrad
Brain and Spinal cord Injury Research center (BASIR), Neuroscience Institude, Tehran University of M
Outcome results
None listed