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

• Published in: Regenerative medicine Vol. 16; no. 6; pp. 535 - 548
• Main Authors: Kuroda, Yutaka, Tanaka, Takeyuki, Miyagawa, Takaki, Hamada, Hidetoshi, Abe, Hiroyasu, Ito-Ihara, Toshiko, Asada, Ryuta, Fujimoto, Yusuke, Takahashi, Daisuke, Tetsunaga, Tomonori, Kaneuji, Ayumi, Takagi, Michiaki, Inaba, Yutaka, Morita, Satoshi, Sugano, Nobuhiko, Tanaka, Sakae, Matsuda, Shuichi, Akiyama, Haruhiko, 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
• Format: Journal Article
• Language: English
• Published: Future Medicine Ltd 01.06.2021
• Subjects: avascular necrosis; bone regeneration; clinical trial; core decompression; FGF; gelatin hydrogel; growth factor; osteonecrosis of femoral head; Phase II; regenerative therapy
• ISSN: 1746-0751; 1746-076X
• DOI: 10.2217/rme-2021-0049

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). 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. 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. rhFGF-2 treatment increases joint preservation time with clinical efficacy, radiological bone regeneration and safety. Osteonecrosis of the femoral head is a disease that causes pain in the hip joint, making it impossible to walk. The causes of the disease are the use of corticosteroids and the drinking of alcohol. As the disease progresses, the hip joint needs to be replaced with an artificial joint. Risks with hip replacement surgery can include infection, implant dislocation, implant fracture and implant wear. The goal of this trial was to treat the disease with simple surgery using a drug called FGF. The surgical wound was 1 cm and the surgery took only 5 min. The results in 64 patients were better than in those without treatment. FGF treatment can be a therapeutic option for osteonecrosis of the femoral head.