Recombinant human FGF-2 for the treatment of early-stage osteonecrosis of the femoral head: TRION, a single-arm, multicenter, Phase II trial-Reference-Cited by-同舟云学术

Recombinant human FGF-2 for the treatment of early-stage osteonecrosis of the femoral head: TRION, a single-arm, multicenter, Phase II trial

Published:2021-06 Issue:6 Volume:16 Page:535-548
ISSN:1746-0751
Container-title:Regenerative Medicine
language:en
Short-container-title:Regenerative Medicine

Author:

Kuroda Yutaka¹^ORCID,Tanaka Takeyuki²,Miyagawa Takaki³,Hamada Hidetoshi⁴,Abe Hiroyasu⁵,Ito-Ihara Toshiko⁶,Asada Ryuta⁷,Fujimoto Yusuke⁸,Takahashi Daisuke⁹,Tetsunaga Tomonori¹⁰,Kaneuji Ayumi¹¹,Takagi Michiaki¹²,Inaba Yutaka¹³,Morita Satoshi⁵,Sugano Nobuhiko¹⁴,Tanaka Sakae²,Matsuda Shuichi¹,Akiyama Haruhiko³,Asano Tsuyoshi,Ito Juji,Oshima Hirofumi,Kaneko Taizo,Fukasawa Yoko,Choe Hyonmin,Ueda Shusuke,Enomoto Kayoko,Tada Harue,Kuroda Akiko,Tabata Yasuhiko,Okuzu Yaichiro,Kawai Toshiyuki,Goto Koji,Nankaku Manabu,Takao Masaki,Ando Wataru,Yamada Kazuki,Yamamoto Michio,Sakai Takashi,Ishidou Yasuhiro,Yamada Shigeru,Ohara Hidetsugu,Fujita Hiroshi,Ohashi Hirotsugu,Iida Hirokazu,Nakamura Takashi

Affiliation:

1. Department of Orthopedic Surgery, Graduate School of Medicine, Kyoto University, Shogoin, Kawahara-cho 54, Sakyo-ku, Kyoto, 606-8507, Japan

2. Department of Orthopedic Surgery, Graduate School of Medicine, The University of Tokyo, Tokyo, 113-8655, Japan

3. Department of Orthopedic Surgery, Gifu University, Gifu, 501-1194, Japan

4. Department of Orthopedic Surgery, Osaka University, Osaka, 565-0871, Japan

5. Department of Biomedical Statistics & Bioinformatics, Kyoto University Graduate School of Medicine, Kyoto, 606-8507, Japan

6. The Clinical & Translational Research Center, Kyoto Prefectural University of Medicine, Kyoto, 602-0841, Japan

7. Innovative & Clinical Research Promotion Center, Graduate School of Medicine, Gifu University, Gifu, 501-1194, Japan

8. Department of Medical Joint Materials, Graduate School of Medical & Dental Sciences, Kagoshima University, Kagoshima, 890-8520, Japan

9. Department of Orthopedic Surgery, Faculty of Medicine & Graduate School of Medicine, Hokkaido University, Hokkaido, 060-8648, Japan

10. Department of Orthopedic Surgery, Okayama University, Okayama, 700-0914, Japan

11. Department of Orthopedic Surgery, Kanazawa Medical University, Ishikawa, 920-0293, Japan

12. Department of Orthopedic Surgery, Yamagata University Faculty of Medicine, Yamagata, 990-2331, Japan

13. Department of Orthopedic Surgery, Yokohama City University, Kanagawa, 236-0004, Japan

14. Department of Orthopedic Medical Engineering, Osaka University Graduate School of Medicine, Osaka, 565-0871, Japan

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.

Funder

Japan Agency for Medical Research and Development

Publisher

Future Medicine Ltd

Subject

Embryology,Biomedical Engineering

Link

https://www.futuremedicine.com/doi/pdf/10.2217/rme-2021-0049

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