Effect of Granulocyte-Colony Stimulating Factor for NeurologicalChanges in Subacute Spinal Cord Injuries
- Conditions
- Traumatic spinal cord injury.Injury of spinal cord, level unspecified
- Registration Number
- IRCT201407177441N3
- Lead Sponsor
- Vice Chancellor for research of Tehran University of Medical Sciences
- Brief Summary
Subcutaneous Granulocyte-Colony Stimulating Factor Administration for Subacute Traumatic Spinal Cord Injuries, Report of Neurological and Functional Outcomes: A Double Blind Randomized Controlled Clinical Trial Object: Granulocyte-Colony Stimulating Factor (G-CSF) is a major growth factor for activation and differentiation of granulocyte colonies in the bone marrow. This cytokine has been widely and safely employed, in different conditions over many years. G-CSF has already been clinically tested for chronic Traumatic Spinal Cord Injuries (TSCIs) in our previous studies. In this study we try to determine the safety and efficacy of G-CSF administration for neurological and functional improvement in sub-acute incomplete TSCI cases. Methods: This phase II/III, prospective, double-blind, placebo-controlled, parallel Randomized Clinical Trial was performed on sixty eligible patients (30 treatment, 30 placebo). Incomplete sub-acute Traumatic Spinal Cord Injuries (TSCIs), American Spinal Injury Association (ASIA) Impairment Scale (AIS) B, C, and D were enrolled. Patients were assessed by ASIA, Spinal Cord Independence Measure (SCIM-III) and International Association of Neurorestoratology-Spinal Cord Injury Functional Rating Scale (IANR-SCIFRS), just before intervention and at 1, 3 and 6 months, after seven daily subcutaneous administrations of 300 µg/day of G-CSF in the treatment group, and placebo in the control group. Results: Amongst sixty volunteers, 28 (93.3%) cases in the G-CSF group, and 26 patients (86.6%) in the placebo group, completed the study protocol. After 6 months of follow up, AIS grade remained unchanged in the placebo group, while in the G-CSF group 5 cases (45.5%) improved from AIS B to C, five (45.5%) AIS C patients improved to AIS D, and 1 case (16.7%) improved from AIS D to E. The mean (±SE) change in ASIA motor score in the G-CSF group was 14.9 (±2.6) scores, which was significantly more than the placebo group (1.4±0.34 scores) (P<0.001). The mean (±SE) light touch and pinprick sensory points, improved by 8.8(±1.9) and 10.7(±2.6) scores in the G-CSF group, while improvements was 2.5(±0.60) and 1.2(±0.40) scores in the placebo group, (P=0.005 and, 0.002 respectively). Evaluation of functional improvement by IANR-SCIFRS instrument revealed significantly more functional improvement in G-CSF group (10.3±1.3 scores), in comparison to the placebo group (3.0±0.81 scores), (P <0.001). Also significant difference was observed between the two groups as measured by SCIM-III instrument (29.6±4.1 vs. 10.3±2.2, P <0.001). Conclusions: Incomplete subacute TSCI is associated with significant motor, sensory, and functional improvement by G-CSF administration. Trial Registration: Iranian Registry of Clinical Trials (IRCT) number, IRCT201407177441N3, www.irct.ir Ethical Committee of TUMS Code: IR.TUMS.REC.1394.608 Classification of Evidence: Type of question: therapeutic; study design: prospective, double blind, placebo controlled, parallel randomized, clinical trial; evidence class: I. Keywords: Spinal cord injury, Granulocyte-Colony Stimulating Factor, Neurological improvement, Clinical trial.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 60
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
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
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method eurological changes (Sensory and Motor). Timepoint: Before intervention,1,3 and 6 months after intervention. Method of measurement: ASIA form.
- Secondary Outcome Measures
Name Time Method 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.