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Multicenter Prospective Nonrandomized Controlled Clinical Trial to Prove Neurotherapeutic Effects of Granulocyte Colony-Stimulating Factor for Acute Spinal Cord Injury: Analyses of Follow-up Cases After at Least 1 Year

Inada, Taigo MD*; Takahashi, Hiroshi MD, PhD*; Yamazaki, Masashi MD, PhD*; Okawa, Akihiko MD, PhD*; Sakuma, Tsuyoshi MD, PhD*; Kato, Kei MD*; Hashimoto, Mitsuhiro MD*; Hayashi, Koichi MD, PhD*; Furuya, Takeo MD, PhD*; Fujiyoshi, Takayuki MD, PhD*; Kawabe, Junko MD, PhD*; Mannoji, Chikato MD, PhD*; Miyashita, Tomohiro MD, PhD*; Kadota, Ryo MD, PhD*; Someya, Yukio MD, PhD*; Ikeda, Osamu MD, PhD*; Hashimoto, Masayuki MD, PhD*; Suda, Kota MD, PhD; Kajino, Tomomichi MD, PhD; Ueda, Haruki MD; Ito, Yasuo MD, PhD; Ueta, Takayoshi MD, PhD§; Hanaoka, Hideki MD, PhD; Takahashi, Kazuhisa MD, PhD*; Koda, Masao MD, PhD*

doi: 10.1097/BRS.0000000000000121
Cervical Spine

Study Design. An open-labeled multicenter prospective nonrandomized controlled clinical trial.

Objective. To confirm the feasibility of using granulocyte colony-stimulating factor (G-CSF) for treatment of acute spinal cord injury (SCI).

Summary of Background Data. We previously reported that G-CSF promotes functional recovery after compression-induced SCI in mice. On the basis of these findings, we conducted a multicenter prospective controlled clinical trial to assess the feasibility of G-CSF therapy for patients with acute SCI.

Methods. The trial ran from August 2009 to March 2011, and included 41 patients with SCI treated within 48 hours of onset. Informed consent was obtained from all patients. After providing consent, patients were divided into 2 groups. In the G-CSF group (17 patients), G-CSF (10 μg/kg/d) was intravenously administered for 5 consecutive days, and in the control group (24 patients), patients were similarly treated except for the G-CSF administration. We evaluated motor and sensory functions using the American Spinal Cord Injury Association score and American Spinal Cord Injury Association impairment scale at 1 week, 3 months, 6 months, and 1 year after onset.

Results. Only 2 patients did not experience American Spinal Cord Injury Association impairment scale improvement in the G-CSF group. In contrast, 15 patients in the control group did not experience American Spinal Cord Injury Association impairment scale improvement. In the analysis of increased American Spinal Cord Injury Association motor score, a significant increase in G-CSF group was detected from 1 week after the administration compared with the control group. After that, some spontaneous increase of motor score was detected in control group, but the significant increase in G-CSF group was maintained until 1 year of follow-up.

Conclusion. Despite the limitation that patient selection was not randomized, the present results suggest the possibility that G-CSF administration has beneficial effects on neurological recovery in patients with acute SCI.

Level of Evidence: 3

Administration of granulocyte colony-stimulating (G-CSF) factor enhanced neurological recovery in 15 of 17 patients with acute spinal cord injury (SCI). Neurotherapeutic effects of G-CSF could be useful for the treatment of acute SCI.

*Spine Section, Department of Orthopaedic Surgery, Chiba University Graduate School of Medicine, Chiba, Japan;

Spinal Cord Injury Center, Hokkaido Chuo Rosai Hospital, Hokkaido, Japan;

Department of Orthopaedic Surgery, Kobe Red Cross Hospital, Kobe, Japan;

§Department of Orthopaedic Surgery, Japan LHWO Spinal Injuries Center, Iizuka, Japan; and

Department of Clinical Research, Chiba University Hospital, Chiba, Japan.

Address correspondence and reprint requests to Masao Koda, MD, PhD, Spine Section, Department of Orthopaedic Surgery, Chiba University Graduate School of Medicine, 1-8-1 Inohana, Chuo-ku, Chiba 260-8677, Japan; E-mail: masaokod@gmail.com

Acknowledgment date: July 10, 2013. First revision date: August 11, 2013. Second revision date: October 21, 2013. Acceptance date: October 28, 2013.

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 relevant financial activities outside the submitted work.

© 2014 by Lippincott Williams & Wilkins