GRANULOCYTE-COLONY-STIMULATING FACTOR FOR ACUTE ISCHEMIC STROKE: A RANDOMIZED CONTROLLED TRIAL (STEMTHER)

 

Technique

 

Abstract.

Introduction. Granulocyte colony-stimulating factor (G-CSF) as a neuroprotector and a stimulator of autologous bone marrow stem cell release can in theory improve the outcome of acute ischemic stroke. We sought to examine the safety and efficacy of using G-CSF (Leucostim®) to treat acute ischemic stroke.

Methods. We conducted a single-centre, randomized, open clinical trial STEMTHER (NCT00901381) involving 20 adult patients with unilateral ischemic stroke in the carotid region who presented within 48 hours of onset. The experimental group (n=10) received subcutaneous G-CSF injections (10 mkg/kg per day) combined with conservative therapy for 5 days. The primary outcome was the degree of disability measured with the modified Rankin Scale obtained at 180 days. The safety was evaluated by frequency of hemorrhagic transformation of infarction and serious adverse events. 

Results. All of the patients in the experimental group completed the 5-day course of treatment. Four of them (3 — in the control and 1 — in the experimental group) were lost to follow-up. Analysis of the therapy efficacy included data on patients who had follow-up examination. Analysis of the therapy safety included data on all patients. The experimental and control group showed no statistical difference in degree of disability and other studied factors.

Conclusion. Acute ischemic stroke therapy with G-CSF (10 mkg/kg per day) for 5 days is safe, but does not improve the outcome at 180 days after stroke onset. Further investigation of high-dose G-CSF efficacy is needed.

 

ischemic stroke, stem cells, colony-stimulating factors, randomized clinical trial.