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.

Abstract

INTRODUCTION:

Granulocyte 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 ANALYSIS:

The 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 DISSEMINATION:

The 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 NUMBER:

UMIN000018752.

• Authors: Masao Koda, Hideki Hanaoka, Takatoshi Sato, Yasuhisa Fujii, Michiko Hanawa, Sho Takahashi, Takeo Furuya, Yasushi Ijima, Junya Saito, Mitsuhiro Kitamura, Seiji Ohtori, Yukei Matsumoto, Tetsuya Abe, Kei Watanabe, Toru Hirano, Masayuki Ohashi, Hirokazu Shoji, Tatsuki Mizouchi, Ikuko Takahashi, Norio Kawahara, Masahito Kawaguchi, Yugo Orita, Takeshi Sasamoto, Masahito Yoshioka, Masafumi Fujii, Katsutaka Yonezawa, Daisuke Soma, Hiroshi Taneichi, Daisaku Takeuchi, Satoshi Inami, Hiroshi Moridaira, Haruki Ueda, Futoshi Asano, Yosuke Shibao, Ikuo Aita, Yosuke Takeuchi, Masaya Mimura, Jun Shimbo, Yukio Someya, Sumio Ikenoue, Hiroaki Sameda, Kan Takase, Yoshikazu Ikeda, Fumitake Nakajima, Mitsuhiro Hashimoto, Tomoyuki Ozawa, Fumio Hasue, Takayuki Fujiyoshi, Koshiro Kamiya, Masahiko Watanabe, Hiroyuki Katoh, Yukihiro Matsuyama, Yu Yamamoto, Daisuke Togawa, Tomohiko Hasegawa, Sho Kobayashi, Go Yoshida, Shin Oe, Tomohiro Banno, Hideyuki Arima, Koji Akeda, Eiji Kawamoto, Hiroshi Imai, Toshihiko Sakakibara, Akihiro Sudo, Yasuo Ito, Tsuyoshi Kikuchi, Shuhei Osaki, Nobuhiro Tanaka, Kazuyoshi Nakanishi, Naosuke Kamei, Shinji Kotaka, Hideo Baba, Tsuyoshi Okudaira, Hiroaki Konishi, Takayuki Yamaguchi, Keigo Ito, Yoshito Katayama, Taro Matsumoto, Tomohiro Matsumoto, Masaru Idota, Haruo Kanno, Toshimi Aizawa, Ko Hashimoto, Toshimitsu Eto, Takehiro Sugaya, Michiharu Matsuda, Kazunari Fushimi, Satoshi Nozawa, Chizuo Iwai, Toshihiko Taguchi, Tsukasa Kanchiku, Hidenori Suzuki, Norihiro Nishida, Masahiro Funaba, Masashi Yamazaki
• Journal: BMJ open (BMJ Open) Vol. 8 Issue 5 Pg. e019083 (05 05 2018) ISSN: 2044-6055 [Electronic] England
• PMID: 29730616 (Publication Type: Clinical Trial Protocol, Journal Article, Research Support, Non-U.S. Gov't)
• Copyright: © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Chemical References

• Granulocyte Colony-Stimulating Factor

Topics

• Acute Disease
• Adolescent
• Adult
• Aged
• Aged, 80 and over
• Clinical Trials, Phase III as Topic
• Double-Blind Method
• Female
• Granulocyte Colony-Stimulating Factor (administration & dosage)
• Humans
• Japan
• Male
• Middle Aged
• Multicenter Studies as Topic
• Neuroprotection (drug effects)
• Prospective Studies
• Randomized Controlled Trials as Topic
• Recovery of Function
• Severity of Illness Index
• Spinal Cord Injuries (drug therapy)
• Time Factors
• Treatment Outcome
• Young Adult