Study protocol for the G-SPIRIT trial: a randomised, placebo-controlled, double-blinded phase III trial of granulocyte colony-stimulating factor-mediated neuroprotection for acute spinal cord injury
Authors: Koda Masao , Hanaoka Hideki , Sato Takatoshi , Fujii Yasuhisa , Hanawa Michiko , Takahashi Sho , Furuya Takeo , Ijima Yasushi , Saito Junya , Kitamura Mitsuhiro , Ohtori Seiji , Matsumoto Yukei , Abe Tetsuya , Watanabe Kei , Hirano Toru , Ohashi Masayuki , Shoji Hirokazu , Mizouchi Tatsuki , Takahashi Ikuko , Kawahara Norio , Kawaguchi Masahito , Orita Yugo , Sasamoto Takeshi , Yoshioka Masahito , Fujii Masafumi , Yonezawa Katsutaka , Soma Daisuke , Taneichi Hiroshi , Takeuchi Daisaku , Inami Satoshi , Moridaira Hiroshi , Ueda Haruki , Asano Futoshi , Shibao Yosuke , Aita Ikuo , Takeuchi Yosuke , Mimura Masaya , Shimbo Jun , Someya Yukio , Ikenoue Sumio , Sameda Hiroaki , Takase Kan , Ikeda Yoshikazu , Nakajima Fumitake , Hashimoto Mitsuhiro , Ozawa Tomoyuki , Hasue Fumio , Fujiyoshi Takayuki , Kamiya Koshiro , Watanabe Masahiko , Katoh Hiroyuki , Matsuyama Yukihiro , Yamamoto Yu , Togawa Daisuke , Hasegawa Tomohiko , Kobayashi Sho , Yoshida Go , Oe Shin , Banno Tomohiro , Arima Hideyuki , Akeda Koji , Kawamoto Eiji , Imai Hiroshi , Sakakibara Toshihiko , Sudo Akihiro , Ito Yasuo , Kikuchi Tsuyoshi , Osaki Shuhei , Tanaka Nobuhiro , Nakanishi Kazuyoshi , Kamei Naosuke , Kotaka Shinji , Baba Hideo , Okudaira Tsuyoshi , Konishi Hiroaki , Yamaguchi Takayuki , Ito Keigo , Katayama Yoshito , Matsumoto Taro , Matsumoto Tomohiro , Idota Masaru , Kanno Haruo , Aizawa Toshimi , Hashimoto Ko , Eto Toshimitsu , Sugaya Takehiro , Matsuda Michiharu , Fushimi Kazunari , Nozawa Satoshi , Iwai Chizuo , Taguchi Toshihiko , Kanchiku Tsukasa , Suzuki Hidenori , Nishida Norihiro , Funaba Masahiro , Yamazaki Masashi 
Published: May 2018

IntroductionGranulocyte colony-stimulating factor (G-CSF) is generally used for neutropaenia. Previous experimental studies revealed that G-CSF promoted neurological recovery after spinal cord injury (SCI). Next, we moved to early phase of clinical trials. In a phase I/IIa trial, no adverse events were observed. Next, we conducted a non-randomised, non-blinded, comparative trial, which suggested the efficacy of G-CSF for promoting neurological recovery. Based on those results, we are now performing a phase III trial.Methods and analysisThe objective of this study is to evaluate the efficacy of G-CSF for acute SCI. The study design is a prospective, multicentre, randomised, double-blinded, placebo-controlled comparative study. The current trial includes cervical SCI (severity of American Spinal Injury Association (ASIA) Impairment Scale B/C) within 48 hours after injury. Patients are randomly assigned to G-CSF and placebo groups. The G-CSF group is administered 400 µg/m2/day×5 days of G-CSF in normal saline via intravenous infusion for 5 consecutive days. The placebo group is similarly administered a placebo. Our primary endpoint is changes in ASIA motor scores from baseline to 3 months. Each group includes 44 patients (88 total patients).Ethics and disseminationThe study will be conducted according to the principles of the World Medical Association Declaration of Helsinki and in accordance with the Japanese Medical Research Involving Human Subjects Act and other guidelines, regulations and Acts. Results of the clinical study will be submitted to the head of the respective clinical study site as a report after conclusion of the clinical study by the sponsor-investigator. Even if the results are not favourable despite conducting the clinical study properly, the data will be published as a paper.Trial registration numberUMIN000018752.