Neuroprotective therapy using granulocyte colony-stimulating factor for patients with worsening symptoms of thoracic myelopathy: a multicenter prospective controlled trial.
METHODS
An open-labeled multicenter prospective controlled clinical trial.


OBJECTIVE
To confirm the feasibility of granulocyte colony-stimulating factor (G-CSF) administration for patients with thoracic myelopathy.


BACKGROUND
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.


METHODS
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.


RESULTS
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.


CONCLUSIONS
The results provide evidence that G-CSF administration 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.
Tsuyoshi
T
Sakuma
Masashi
M
Yamazaki
Akihiko
A
Okawa
Hiroshi
H
Takahashi
Kei
K
Kato
Mitsuhiro
M
Hashimoto
Koichi
K
Hayashi
Takeo
T
Furuya
Takayuki
T
Fujiyoshi
Junko
J
Kawabe
Chikato
C
Mannoji
Tomohiro
T
Miyashita
Ryo
R
Kadota
Yukio
Y
Someya
Osamu
O
Ikeda
Tomonori
T
Yamauchi
Masayuki
M
Hashimoto
Toshimi
T
Aizawa
Atsushi
A
Ono
Shiro
S
Imagama
Tokumi
T
Kanemura
Hideki
H
Hanaoka
Kazuhisa
K
Takahashi
Masao
M
Koda
D061605:Administration, Intravenous; D000328:Adult; D000368:Aged; D004334:Drug Administration Schedule; D005240:Feasibility Studies; D005260:Female; D016179:Granulocyte Colony-Stimulating Factor / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D007958:Leukocyte Count; D008297:Male; D008875:Middle Aged; D018696:Neuroprotective Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D011446:Prospective Studies; D020127:Recovery of Function / Q000187:drug effects*; D013118:Spinal Cord Diseases / Q000188:drug therapy* / Q000473:pathology / Q000503:physiopathology; D013904:Thoracic Vertebrae; D016896:Treatment Outcome; D055815:Young Adult
D018696:Neuroprotective Agents; D016179:Granulocyte Colony-Stimulating Factor