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Safety and efficacy of sustained release of basic fibroblast growth factor using gelatin hydrogel in patients with critical limb ischemia.
Kumagai, Motoyuki; Marui, Akira; Tabata, Yasuhiko; Takeda, Takahide; Yamamoto, Masaya; Yonezawa, Atsushi; Tanaka, Shiro; Yanagi, Shigeki; Ito-Ihara, Toshiko; Ikeda, Takafumi; Murayama, Toshinori; Teramukai, Satoshi; Katsura, Toshiya; Matsubara, Kazuo; Kawakami, Koji; Yokode, Masayuki; Shimizu, Akira; Sakata, Ryuzo.
Afiliación
  • Kumagai M; Department of Cardiovascular Surgery, Kyoto University Graduate School of Medicine, 54 Shogoin Kawahara-cho, Sakyo-ku, Kyoto, 606-8507, Japan.
  • Marui A; Division of Cardiovascular Surgery, Tenri Hospital, Nara, Japan.
  • Tabata Y; Department of Experimental Therapeutics, Institute for Advancement of Clinical and Translational Science, Kyoto University Hospital, Kyoto, Japan.
  • Takeda T; Department of Biomaterials, Institute for Frontier Medical Sciences, Kyoto University, Kyoto, Japan.
  • Yamamoto M; Department of Cardiovascular Surgery, Kyoto University Graduate School of Medicine, 54 Shogoin Kawahara-cho, Sakyo-ku, Kyoto, 606-8507, Japan.
  • Yonezawa A; Department of Experimental Therapeutics, Institute for Advancement of Clinical and Translational Science, Kyoto University Hospital, Kyoto, Japan.
  • Tanaka S; Department of Biomaterials, Institute for Frontier Medical Sciences, Kyoto University, Kyoto, Japan.
  • Yanagi S; Department of Clinical Pharmacology and Therapeutics, Kyoto University Hospital, Kyoto, Japan.
  • Ito-Ihara T; Department of Pharmacoepidemiology, Graduate School of Medicine and Public Health, Kyoto University, Kyoto, Japan.
  • Ikeda T; Department of Data Science, Institute for Advancement of Clinical and Translational Science, Kyoto University Hospital, Kyoto, Japan.
  • Murayama T; Department of Cardiovascular Surgery, Kumamoto Central Hospital, Kumamoto, Japan.
  • Teramukai S; Department of Clinical Innovative Medicine, Institute for Advancement of Clinical and Translational Science, Kyoto University Hospital, Kyoto, Japan.
  • Katsura T; Department of Experimental Therapeutics, Institute for Advancement of Clinical and Translational Science, Kyoto University Hospital, Kyoto, Japan.
  • Matsubara K; Department of Clinical Innovative Medicine, Institute for Advancement of Clinical and Translational Science, Kyoto University Hospital, Kyoto, Japan.
  • Kawakami K; Department of Biostatistics, Kyoto Prefectural University of Medicine, Kyoto, Japan.
  • Yokode M; Department of Clinical Pharmacology and Therapeutics, Kyoto University Hospital, Kyoto, Japan.
  • Shimizu A; Department of Clinical Pharmacology and Therapeutics, Kyoto University Hospital, Kyoto, Japan.
  • Sakata R; Department of Pharmacoepidemiology, Graduate School of Medicine and Public Health, Kyoto University, Kyoto, Japan.
Heart Vessels ; 31(5): 713-21, 2016 May.
Article en En | MEDLINE | ID: mdl-25861983
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.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Portadores de Fármacos / Factor 2 de Crecimiento de Fibroblastos / Tolerancia al Ejercicio / Neovascularización Fisiológica / Extremidad Inferior / Inductores de la Angiogénesis / Enfermedad Arterial Periférica / Gelatina / Isquemia Tipo de estudio: Diagnostic_studies Límite: Aged / Female / Humans / Male / Middle aged País/Región como asunto: Asia Idioma: En Revista: Heart Vessels Asunto de la revista: CARDIOLOGIA Año: 2016 Tipo del documento: Article País de afiliación: Japón Pais de publicación: Japón
Texto completo
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Imprimir
XML
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Portadores de Fármacos / Factor 2 de Crecimiento de Fibroblastos / Tolerancia al Ejercicio / Neovascularización Fisiológica / Extremidad Inferior / Inductores de la Angiogénesis / Enfermedad Arterial Periférica / Gelatina / Isquemia Tipo de estudio: Diagnostic_studies Límite: Aged / Female / Humans / Male / Middle aged País/Región como asunto: Asia Idioma: En Revista: Heart Vessels Asunto de la revista: CARDIOLOGIA Año: 2016 Tipo del documento: Article País de afiliación: Japón Pais de publicación: Japón