自体脂肪细胞复合注射型胶原支架修复严重声带损伤的临床研究
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移植后的细胞保留和存活仍然是自体细胞治疗严重声带损伤长期有效性的主要问题。在本研究中，使用可注射的胶原支架递送自体脂肪细胞（AFCs）来修复严重的声带损伤。我们发现可注射的胶原支架可以增强绿色荧光蛋白标记的脂肪细胞在大鼠移植部位的保留和存活。基于这些数据，进行了一项随机对照的临床试验，以评估胶原支架复合AFCs移植治疗严重声带损伤的安全性和有效性。10名声带麻痹患者被随机分为对照组（仅用AFCs）和干预组（AFCs+胶原）。在全身麻醉下，将含有或不含有胶原支架的AFCs分别注射到患者的声带中。在术后24个月内定期评估其安全性和有效性。随访期间，所有患者均未出现明显并发症。胶原支架在注射后保持了植入物的稳定性，并重建了声带结构。通过语音障碍指数（VHI）问卷的语音质量评估，以及最大发声时间、抖动和微光的声学分析，观察患者的语音质量改善。AFCs+胶原组患者在术后6、12和24个月的VHI评分显著高于AFCs组。这证明可注射胶原支架负载AFCs治疗声带损伤是安全且有效的。
Retention and survival of transplanted cells remain a major challenge to the long-term efficacy of autologous cell therapy for severe vocal fold injuries. In this study, injectable collagen scaffolds were used to deliver autologous fat cells (AFCs) for repairing severe vocal fold injuries. We found that injectable collagen scaffolds could enhance the retention and survival of green fluorescent protein-labeled fat cells at the rat transplantation sites. Based on these findings, a randomized controlled clinical trial was conducted to evaluate the safety and efficacy of collagen scaffold-combined AFC transplantation for the treatment of severe vocal fold injuries. Ten patients with vocal fold paralysis were randomly assigned to either the control group (AFCs only) or the intervention group (AFCs + collagen). Under general anesthesia, AFCs with or without collagen scaffolds were injected into the patients' vocal folds respectively. Their safety and efficacy were regularly evaluated within 24 months post-surgery. No obvious complications were observed in all patients during the follow-up period. The collagen scaffolds maintained the stability of the implants after injection and reconstructed the vocal fold structure. Improvements in patients' voice quality were observed via voice quality assessment using the Voice Handicap Index (VHI) questionnaire, as well as acoustic analyses of maximum phonation time, jitter, and shimmer. Patients in the AFCs + collagen group had significantly higher VHI scores at 6, 12, and 24 months postoperatively than those in the AFCs-only group. This demonstrates that injectable collagen scaffolds loaded with AFCs are safe and effective for the treatment of vocal fold injuries.
