• Tsuyoshi Sakuma, Masashi Yamazaki, Akihiko Okawa, Hiroshi Takahashi, Kei Kato, Mitsuhiro Hashimoto, Koichi Hayashi, Takeo Furuya, Takayuki Fujiyoshi, Junko Kawabe, Chikato Mannoji, Tomohiro Miyashita, Ryo Kadota, Yukio Someya, Osamu Ikeda, Tomonori Yamauchi, Masayuki Hashimoto, Toshimi Aizawa, Atsushi Ono, Shiro Imagama, Tokumi Kanemura, Hideki Hanaoka, Kazuhisa Takahashi, and Masao Koda.
• Department of Orthopaedic Surgery, Chiba University Graduate School of Medicine, Chuo-ku, Chiba, Japan.
• Spine. 2012 Aug 1;37(17):1475-8.

Study DesignAn open-labeled multicenter prospective controlled clinical trial.ObjectiveTo confirm the feasibility of granulocyte colony-stimulating factor (G-CSF) administration for patients with thoracic myelopathy.Summary Of Background DataAlthough 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.MethodsPatients 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.ResultsThere 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.ConclusionThe results provide evidence that G-CSF administration caused neurological recovery in patients with worsening symptoms of thoracic compression myelopathy.

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