Neuroprotective Therapy Using Granulocyte Colony-Stimulating Factor for Patients With Worsening Symptoms of Thoracic Myelopathy: A Multicenter Prospective Controlled Trial

• Published in: Spine (Philadelphia, Pa. 1976) Pa. 1976), 2012-08, Vol.37 (17), p.1475-1478
• Main Authors: SAKUMA, Tsuyoshi, YAMAZAKI, Masashi, MANNOJI, Chikato, MIYASHITA, Tomohiro, KADOTA, Ryo, SOMEYA, Yukio, IKEDA, Osamu, YAMAUCHI, Tomonori, HASHIMOTO, Masayuki, AIZAWA, Toshimi, ONO, Atsushi, IMAGAMA, Shiro, OKAWA, Akihiko, KANEMURA, Tokumi, HANAOKA, Hideki, TAKAHASHI, Kazuhisa, KODA, Masao, TAKAHASHI, Hiroshi, KATO, Kei, HASHIMOTO, Mitsuhiro, HAYASHI, Koichi, FURUYA, Takeo, FUJIYOSHI, Takayuki, KAWABE, Junko
• Format: Article
• Language: English
• Subjects: Administration, Intravenous; Adult; Aged; Biological and medical sciences; Cerebrospinal fluid. Meninges. Spinal cord; Drug Administration Schedule; Feasibility Studies; Female; Granulocyte Colony-Stimulating Factor - administration & dosage; Granulocyte Colony-Stimulating Factor - adverse effects; Granulocyte Colony-Stimulating Factor - therapeutic use; Humans; Leukocyte Count; Male; Medical sciences; Middle Aged; Multiple sclerosis and variants. Guillain barré syndrome and other inflammatory polyneuropathies. Leukoencephalitis; Nervous system (semeiology, syndromes); Neurology; Neuroprotective Agents - administration & dosage; Neuroprotective Agents - adverse effects; Neuroprotective Agents - therapeutic use; Prospective Studies; Recovery of Function - drug effects; Spinal Cord Diseases - drug therapy; Spinal Cord Diseases - pathology; Spinal Cord Diseases - physiopathology; Thoracic Vertebrae; Treatment Outcome; Young Adult
• ISSN: 0362-2436; 1528-1159
• DOI: 10.1097/BRS.0b013e318260cc71

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.