@article{ae8252955c82457b916270b42b94398c,
title = "Recombinant human FGF-2 for the treatment of early-stage osteonecrosis of the femoral head: TRION, a single-arm, multicenter, Phase II trial",
abstract = "Aim: This study aimed to evaluate the 2-year outcomes from a clinical trial of recombinant human FGF-2 (rhFGF-2) for osteonecrosis of the femoral head (ONFH). Patients & methods: Sixty-four patients with nontraumatic, precollapse and large ONFHs were percutaneously administered with 800 μg rhFGF-2 contained in gelatin hydrogel. Setting the end point of radiological collapse, we analyzed the joint preservation period of the historical control. Changes in two validated clinical scores, bone regeneration and safety were evaluated. Results: Radiological joint preservation time was significantly higher in the rhFGF-2 group than in the control group. The ONFHs tended to improve to smaller ONFHs. The postoperative clinical scores significantly improved. Thirteen serious adverse events showed recovery. Conclusion: rhFGF-2 treatment increases joint preservation time with clinical efficacy, radiological bone regeneration and safety.",
keywords = "FGF, Phase II, avascular necrosis, bone regeneration, clinical trial, core decompression, gelatin hydrogel, growth factor, osteonecrosis of femoral head, regenerative therapy",
author = "{TRION trial collaborators} and Yutaka Kuroda and Takeyuki Tanaka and Takaki Miyagawa and Hidetoshi Hamada and Hiroyasu Abe and Toshiko Ito-Ihara and Ryuta Asada and Yusuke Fujimoto and Daisuke Takahashi and Tomonori Tetsunaga and Ayumi Kaneuji and Michiaki Takagi and Yutaka Inaba and Satoshi Morita and Nobuhiko Sugano and Sakae Tanaka and Shuichi Matsuda and Haruhiko Akiyama and Tsuyoshi Asano and Juji Ito and Hirofumi Oshima and Taizo Kaneko and Yoko Fukasawa and Hyonmin Choe and Shusuke Ueda and Kayoko Enomoto and Harue Tada and Akiko Kuroda and Yasuhiko Tabata and Yaichiro Okuzu and Toshiyuki Kawai and Koji Goto and Manabu Nankaku and Masaki Takao and Wataru Ando and Kazuki Yamada and Michio Yamamoto and Takashi Sakai and Yasuhiro Ishidou and Shigeru Yamada and Hidetsugu Ohara and Hiroshi Fujita and Hirotsugu Ohashi and Hirokazu Iida and Takashi Nakamura",
note = "Funding Information: This investigator-initiated trial was supported by competitive grants from the Japan Agency forMedical Research and Development. rhFGF-2 was provided by Kaken Pharmaceutical Co. (Tokyo, Japan). The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed. Funding Information: This study on rhFGF-2 to prevent femoral head collapse (TRION) was an investigator-initiated, multicenter, prospective, open-label, single-arm, historical control, Phase II trial conducted at four university hospitals in Japan (The University of Tokyo, Gifu University, Osaka University and Kyoto University). The study was funded by the Japan Agency for Medical Research and Development, registered in the University Hospital Medical Information Network clinical trials registry (number UMIN000020340) and conducted in accordance with the latest regulatory requirements, including the Declaration of Helsinki and the International Council for Harmonisation{\textquoteright}s Good Clinical Practice regulations. The trial registered 65 patients, 64 of whom underwent rhFGF-2 treatment between Publisher Copyright: {\textcopyright} 2021 ",
year = "2021",
month = jun,
doi = "10.2217/rme-2021-0049",
language = "English",
volume = "16",
pages = "535--548",
journal = "Regenerative Medicine",
issn = "1746-0751",
publisher = "Future Medicine Ltd.",
number = "6",
}