Novel Collagen/Gelatin Scaffold with Sustained Release of Basic Fibroblast Growth Factor: Clinical Trial for Chronic Skin Ulcers
Novel Collagen/Gelatin Scaffold with Sustained Release of Basic Fibroblast Growth Factor: Clinical Trial for Chronic Skin Ulcers
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DOI：
10.1089/ten.tea.2012.0634
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发表时间：
2013-09-01
影响因子：
4.1
通讯作者：
Suzuki, Shigehiko
中科院分区：
文献类型：
--
作者：
Morimoto, Naoki;Yoshimura, Kenichi;Suzuki, Shigehiko
慢性皮肤溃疡如糖尿病溃疡和静脉性腿部溃疡正在增加，并且是医疗保健中的昂贵问题。我们已经开发了一种新型的人工真皮，胶原/明胶海绵（CGS），这是能够持续释放碱性成纤维细胞生长因子（bFGF）超过10天。本研究的目的是探讨含bFGF的CGS治疗慢性皮肤溃疡的安全性和有效性。对至少4周内未愈合的慢性皮肤溃疡患者，在清创后用含7或14 μ g/cm（2）bFGF的CGS进行治疗，并在应用后14天评估伤口床的改善情况。伤口床改善定义为第14天的颗粒状和上皮化面积，清创后与基线伤口面积的比例为50%或更高。在中心审查中，由设盲审查员使用校准器拍摄的伤口数字图像独立测量伤口面积、第14天的伤口面积和第14天的肉芽面积。随访至用药后28 d，观察与CGS应用相关的不良反应。从2010年5月至2011年6月，入组了17例患者，其中16例患者的伤口床改善。在第2步的随机化患者中，低剂量组和高剂量组之间未观察到显著差异。未观察到严重不良反应。与研究治疗有明确因果关系的不良反应为轻度，患者很快恢复。这项研究是CGS的首次人体临床试验，显示了含bFGF的CGS治疗慢性皮肤溃疡的安全性和有效性。这种联合疗法可能是一种有前途的治疗慢性皮肤溃疡。
Chronic skin ulcers such as diabetic ulcers and venous leg ulcers are increasing and are a costly problem in healthcare. We have developed a novel artificial dermis, collagen/gelatin sponge (CGS), which is capable of sustained release of basic fibroblast growth factor (bFGF) for more than 10 days. The objective of this study was to investigate the safety and efficacy of CGS impregnated with bFGF in the treatment of chronic skin ulcers. Patients with chronic skin ulcers that had not healed in at least 4 weeks were treated with CGS impregnated with bFGF at 7 or 14 mu g/cm(2) after debridement, and the wound bed improvement was assessed 14 days after application. Wound bed improvement was defined as a granulated and epithelialized area on day 14 with a proportion to the baseline wound area after debridement of 50% or higher. The wound area, the wound area on day 14, and the granulation area on day 14 were independently measured by blinded reviewers in a central review using digital images of wounds taken with a calibrator. Patients were followed up until 28 days after application to observe the adverse reactions related to the application of CGS. From May 2010 to June 2011, 17 patients were enrolled and, in 16 patients, the wound bed improved. Among the randomized patients in step 2, no significant difference was seen between the low-dose group and the high-dose group. No serious adverse reactions were observed. Adverse reactions with a clear causal relationship to the study treatment were mild and patients quickly recovered from them. This study is the first-in-man clinical trial of CGS and showed the safety and efficacy of CGS impregnated with bFGF in the treatment of chronic skin ulcers. This combination therapy could be a promising therapy for chronic skin ulcers.