論文

査読有り
2016年5月

Safety and efficacy of sustained release of basic fibroblast growth factor using gelatin hydrogel in patients with critical limb ischemia.

Heart and vessels
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回数 : 18
  • Motoyuki Kumagai
  • ,
  • Akira Marui
  • ,
  • Yasuhiko Tabata
  • ,
  • Takahide Takeda
  • ,
  • Masaya Yamamoto
  • ,
  • Atsushi Yonezawa
  • ,
  • Shiro Tanaka
  • ,
  • Shigeki Yanagi
  • ,
  • Toshiko Ito-Ihara
  • ,
  • Takafumi Ikeda
  • ,
  • Toshinori Murayama
  • ,
  • Satoshi Teramukai
  • ,
  • Toshiya Katsura
  • ,
  • Kazuo Matsubara
  • ,
  • Koji Kawakami
  • ,
  • Masayuki Yokode
  • ,
  • Akira Shimizu
  • ,
  • Ryuzo Sakata

31
5
開始ページ
713
終了ページ
21
記述言語
英語
掲載種別
研究論文(学術雑誌)
DOI
10.1007/s00380-015-0677-x

As a form of therapeutic angiogenesis, we sought to investigate the safety and efficacy of a sustained-release system of basic fibroblast growth factor (bFGF) using biodegradable gelatin hydrogel in patients with critical limb ischemia (CLI). We conducted a phase I-IIa study that analyzed 10 CLI patients following a 200-μg intramuscular injection of bFGF-incorporated gelatin hydrogel microspheres into the ischemic limb. Primary endpoints were safety and transcutaneous oxygen pressure (TcO2) at 4 and 24 weeks after treatment. During the follow-up, there was no death or serious procedure-related adverse event. After 24 weeks, TcO2 (28.4 ± 8.4 vs. 46.2 ± 13.0 mmHg for pretreatment vs after 24 weeks, p < 0.01) showed significant improvement. Regarding secondary endpoints, the distance walked in 6 min (255 ± 105 vs. 318 ± 127 m, p = 0.02), the Rutherford classification (4.4 ± 0.5 vs. 3.1 ± 1.4, p = 0.02), the rest pain scale (1.7 ± 1.0 vs. 1.2 ± 1.3, p = 0.03), and the cyanotic scale (2.0 ± 1.1 vs. 0.9 ± 0.9, p < 0.01) also showed improvement. The blood levels of bFGF were within the normal range in all patients. A subanalysis of patients with arteriosclerosis obliterans (n = 7) or thromboangiitis obliterans (Buerger's disease) (n = 3) revealed that TcO2 had significantly improved in both subgroups. TcO2 did not differ between patients with or without chronic kidney disease. The sustained release of bFGF from biodegradable gelatin hydrogel may offer a safe and effective form of angiogenesis for patients with CLI.

リンク情報
DOI
https://doi.org/10.1007/s00380-015-0677-x
PubMed
https://www.ncbi.nlm.nih.gov/pubmed/25861983
ID情報
  • DOI : 10.1007/s00380-015-0677-x
  • PubMed ID : 25861983

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