Safety of granulocyte colony-stimulating factor (G-CSF) administration for traumatic brain injury patients: an open-label, phase I study

IntroductionTraumatic Brain Injury (TBI) is a major cause of long-term disability and death in young adults. The paucity of pharmaceutical therapy for post–acute TBI recovery remains a crucial medical challenge. Granulocyte-Colony Stimulating Factor (G-CSF), which is key hematopoietic growth factors, has shown neuroprotective and neurorestorative effects in experimental TBI.ObjectiveIn this study we have tried to determine the safety and possible therapeutic effects of G-CSF administration for TBI.MethodsIn this phase I study, G-CSF is administered to 5 patients with TBI, and midterm complication and outcomes are assessed. Five included patients, received seven subcutaneous G-CSF (300 μg/ml/day) for 7 days, thereafter possible complications and neurological outcomes are assessed for at least 6 months. All the cases had completed an outpatient rehabilitation program in the chronic phase, and were in a neurological and functional plateau. Patients were assessed by ASIA just before intervention and at 6 months after intervention. Also memory and functional status were assessed.ResultsThe mean age of the patients was 27.6 years, and there were 80.0 % males with about 4.6 years of disease duration. The mean post-injection WBC count was 27,660 /mm3 and 7,350 /mm3 in pre-injection period, showing a significant increase (P < 0.001). The mean improvement in ASIA motor score was 7 scores and also there was 28 scores improvement in pinprick sensory scores in one patient that had sensory deficit. There was one individual with transient bone pain that subsided spontaneously at most 1 week after the last dose of G-CSF.ConclusionsOur preliminary results show that G-CSF administration in TBI patients is a safe process and is associated with neurological as well as functional and memory improvement. Higher level evidence may be needed to assess the hypothesis.

کلیدواژه ها:

Traumatic brain injury ، Granulocyte-colony stimulating factor ، Neurological improvement ، Stem cell therapy