Injection of Cultured Autologous Fibroblasts for Human Vocal Fold Scars
Injection of Cultured Autologous Fibroblasts for Human Vocal Fold Scars
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DOI：
10.1002/lary.21417
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发表时间：
2011-04-01
期刊：
影响因子：
2.6
通讯作者：
Berke, Gerald S.
中科院分区：
文献类型：
--
作者：
Chhetri, Dinesh K.;Berke, Gerald S.
目的：本研究评估了注射自体成纤维细胞到固有层治疗声带scarring.Study Design的安全性和有效性：一个前瞻性的，开放标签，单臂，试点研究在一个单一的三级care center.Methods：autoblasts成纤维细胞扩大在细胞培养从五个人类受试者声带瘢痕的颊粘膜穿孔活检。每隔四周，将1-2 x 10（7）个细胞/mL的三个剂量注射到每个瘢痕声带的浅层固有层中。主要疗效指标是粘膜波等级的客观评价;次要指标包括声学分析、患者完成的嗓音障碍指数（VHI）调查和嗓音质量问卷。安全性评估包括临床实验室血液检查、生命体征和不良事件监测。患者随访12个月后，第一treatment.Results：粘液波等级改善，改善持续到12个月。VHI和语音质量问卷在第12个月也有持续改善。自体成纤维细胞多次注射到固有层中耐受性良好。暂时性耳痛注意到治疗后，在两个subjects.Conclusions：这项研究表明，注射自体成纤维细胞到瘢痕声带固有层是安全的。粘膜波分级、VHI和嗓音质量问卷的12个月数据支持了结局改善的持续趋势。
Objectives: This study evaluated the safety and effectiveness of injection of autologous fibroblasts into the lamina propria layer to treat vocal fold scarring.Study Design: A prospective, open-label, single arm, pilot study at a single tertiary care center.Methods: Autologous fibroblasts were expanded in cell culture from punch biopsies of the buccal mucosa of five human subjects with vocal fold scarring. Three doses of 1-2 x 10(7) cells/mL were injected into the superficial lamina propria layer of each scarred vocal fold at four-week intervals. The primary efficacy measure was an objective evaluation of the mucosal wave grade; secondary measures included acoustic analyses, a patient-completed voice handicap index (VHI) survey, and voice quality questionnaire. Safety assessments included clinical laboratory blood tests, vital signs, and monitoring for adverse events. Patients were followed for 12 months following the first treatment.Results: Mucosal wave grade improved and the improvement was sustained through month 12. Sustained improvements through month 12 were also noted for the VHI and voice quality questionnaire. Multiple injections of autologous fibroblasts into the lamina propria were well tolerated. Temporary otalgia was noted following treatment in two subjects.Conclusions: This study demonstrates that injection of autologous fibroblasts into the scarred vocal fold lamina propria layer is safe. Sustained trends for improved outcome were supported by 12-month data for mucosal wave grade, VHI, and voice quality questionnaire.