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

Abstract

STUDY DESIGN:

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.

SUMMARY OF BACKGROUND DATA:

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.

CONCLUSION:

The results provide evidence that G-CSF administration caused neurological recovery in patients with worsening symptoms of thoracic compression myelopathy.

• Authors: 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, Masao Koda
• Journal: Spine (Spine (Phila Pa 1976)) Vol. 37 Issue 17 Pg. 1475-8 (Aug 01 2012) ISSN: 1528-1159 [Electronic] United States
• PMID: 22652593 (Publication Type: Controlled Clinical Trial, Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't)

Chemical References

• Neuroprotective Agents
• Granulocyte Colony-Stimulating Factor

Topics

• Administration, Intravenous
• Adult
• Aged
• Drug Administration Schedule
• Feasibility Studies
• Female
• Granulocyte Colony-Stimulating Factor (administration & dosage, adverse effects, therapeutic use)
• Humans
• Leukocyte Count
• Male
• Middle Aged
• Neuroprotective Agents (administration & dosage, adverse effects, therapeutic use)
• Prospective Studies
• Recovery of Function (drug effects)
• Spinal Cord Diseases (drug therapy, pathology, physiopathology)
• Thoracic Vertebrae
• Treatment Outcome
• Young Adult