An open-labeled multicenter prospective controlled clinical trial.
To confirm the feasibility of granulocyte colony–stimulating factor (G-CSF) administration for patients with thoracic myelopathy.
Although G-CSF is best known as an important cytokine commonly used to treat neutropenia, it also has nonhematopoietic functions. Previous experimental studies have shown that G-CSF can enhance tissue regeneration of several organs, such as the heart and the brain. We previously reported that G-CSF promotes functional recovery after spinal cord injury in rodents. On the basis of those findings, we started a clinical trial of neuroprotective therapy, using G-CSF for patients with worsening symptoms of thoracic myelopathy.
Patients whose Japanese Orthopaedic Association (JOA) score for thoracic myelopathy had decreased 2 points or more during a recent 1-month period were eligible for entry. After giving informed consent, patients were assigned to G-CSF and control groups. The G-CSF group (n = 10) received G-CSF 10 μg/kg per day intravenously for 5 consecutive days. The control group (n = 14) received similar treatments as the G-CSF group except for G-CSF administration. The primary outcome was JOA recovery rate at 1 month after G-CSF administration or initial treatment.
There was greater improvement in neurological functioning between baseline and 1-month follow-up in the G-CSF group (JOA recovery rate: 29.1 ± 20.5%) than in the control group (JOA recovery rate: 1.1 ± 4.2%) (P < 0.01). No serious adverse events occurred during or after the G-CSF administration.
The results provide evidence that G-CSF administration caused neurological recovery in patients with worsening symptoms of thoracic compression myelopathy.
This prospective controlled clinical trial showed that intravenous administration of granulocyte colony–stimulating factor (10 μg/kg per day) for 5 consecutive days caused neurological recovery in patients with worsening symptoms of thoracic compression myelopathy.
*Department of Orthopaedic Surgery, Chiba University Graduate School of Medicine, Chuo-ku, Chiba, Japan
†Department of Orthopaedic Surgery, Tohoku University School of Medicine, Miyagi, Japan
‡Department of Orthopaedic Surgery, Hirosaki University Graduate School of Medicine, Aomori Prefecture, Japan
§Department of Orthopaedic Surgery, Nagoya University Graduate School of Medicine, Nagoya, Japan
¶Spine Center, Konan Kosei Hospital, Aichi, Japan
‖Department of Clinical Research, Chiba University Hospital, Chiba, Japan.
Address correspondence and reprint requests to Masashi Yamazaki, MD, PhD, Department of Orthopaedic Surgery, Chiba University Graduate School of Medicine, 1-8-1 Inohana, Chuo-ku, Chiba 260-8677, Japan; E-mail: firstname.lastname@example.org
Acknowledgment date: September 6, 2011. Revision date: January 13, 2012. Acceptance date: January 30, 2012.
The device(s)/drug(s) that is/are the subject of this manuscript is/are not FDA approved for this indication and is/are not commercially available in the United States.
Health Labour Science Research Grant of Japan funds were received to support this work.
No benefits in any form have been or will be received from a commercial party related directly or indirectly to the subject of this manuscript.