Friday, August 10, 2012
From the Desk of Masashi Yamazaki, MD, PhD
In the present study, we conducted the first clinical trial using G-CSF for patients with worsening symptoms of thoracic compressive myelopathy. One month after G-CSF administration, mean recovery rate of JOA score was 29.1%. In contrast, it was 1.1% in the control group at one month after initial treatment. The results strongly suggest that G-CSF administration exhibited a neuroprotective effect for the injured spinal cord in patients with worsening symptoms of thoracic myelopathy and lessened the severity of myelopathy.
To the best of our knowledge, there has been no other medical treatment that has provided reliable evidence for improvement of thoracic myelopathy. The present study provides evidence that G-CSF neuroprotective therapy may be useful as a medical treatment for patients with worsening symptoms of thoracic compressive myelopathy. By introducing G-CSF therapy, it may be possible to avoid surgical treatment in some cases of progressive myelopathy. The G-CSF therapy may be especially useful for patients in whom the treatment for comorbidities other than myelopathy needs be given priority and thus would require a long waiting period before surgery. We believe that neuroprotective therapy using G-CSF is a therapeutic strategy for progressive thoracic myelopathy, especially as a potential complementary treatment for surgical decompression.
Of course, we understand that a limitation of the present study was that the trial was performed as an open-labeled study and the selection of patients to the G-CSF group and control group was not randomized. Thus, we cannot deny the possibility that a placebo effect from the injection may contribute to the improvement of neurological symptoms. To increase the level of evidence, in the next stage the study design should be a randomized, double-blinded placebo-controlled study. By conducting a phase IIb clinical trial with the study design described above, we will be able to reach a better conclusion regarding the effectiveness of G-CSF neuroprotective therapy for patients with worsening symptoms of thoracic compression myelopathy.