A Randomized Control Trial of Granulocyte Colony Stimulating Factor (G-CSF) Intervention in Acute Ischemic Stroke to Improve Functional Outcome (P1.139)

Objective: It is hypothesized that intervention with G-CSF within 7 days of stroke onset is associated with improved functional outcome at three months. Back ground: Acute ischemic stroke is associated with significant morbidity and mortality. Subcutaneous administration of G-CSF was associated with neuroprotection, reduction in infarct volume, anti-inflammation, angiogenesis and mobilization of bone-marrow derived stem cells to the peripheral blood and improvement in neurological function Materials and Methods: This is a open label randomized controlled trial. Forty seven patients with acute ischemic stroke were randomly assigned to receive either best medical treatment (25), or in addition an Injection of Granulocyte Colony stimulating factor (G-CSF) 15µg/Kg/day SC ( 22), for 5 days from fifth day post-stroke. Indicators of stroke severity, recovery and functional ability were evaluated at baseline with NIHSS, Barthel index and modified Rankin’s scales, and by repeat assessments after 3 months. Statistical analyses were performed using nonparametric tests Results: Nine patients in control group and three patients in experimental group died due to aspiration pneumonia, urinary sepsis and increased intracranial pressure. The inter-group difference is not statistically significant. Furthermore, six patients in the control group and four in intervention group were lost to follow up. No serious adverse effects were seen in rest of patients in intervention or control arm. At the 3 months post-stroke time-point, the intervention group showed better improvement as compared to control group in all the three stroke scales. However percentage improvement between the two groups could not attain statistical significance. Conclusions: Endogenous mobilization of bonemarrow hematopoietic stem cells by GCSF administration perhaps leads to better functional outcome. This study provides preliminary evidence of potential safety, feasibility, and tolerability of G-CSF therapy in patients with acute ischaemic stroke. The safety and modest efficacy demonstrated in this study augurs for further studies with a larger sample sizes and longer follow ups. Disclosure: Dr. Gorthi has nothing to disclose. Dr. Nauwhar has nothing to disclose. Dr. Gupta has nothing to disclose. Dr. Hassan has nothing to disclose.