Kaiser Benedict, Miot Sylvie, Wixmerten Anke, Pullig Oliver, Eyrich Matthias, Fulco Ilario, Vavrina Josef, Schaefer Dirk J, Martin Ivan, Barbero Andrea, Haug Martin D
Department of Plastic and Hand Surgery, University Hospital Basel.
Department of Biomedicine, University of Basel, University Hospital Basel, Basel, Switzerland.
Int J Surg. 2024 Oct 1;110(10):6573-6580. doi: 10.1097/JS9.0000000000001843.
This phase I clinical trial assessed the use of autologous nasal chondrocyte tissue-engineered cartilage (N-TEC) for functional repair of nasal septal perforations (NSP).
The most widely used technique to treat NSP, namely interposition grafting with a polydioxanone (PDS) plate combined with a deep temporal fascia (DTF) graft, is still suboptimal towards patient satisfaction and revision rates.
Patients ( n =5, all female, age range: 23-54 years) had a 0.5-2.0 cm diameter NSP. N-TEC was manufactured by expansion and 3D culture of autologous nasal septum chondrocytes into Chondro-Gide collagen membranes. N-TEC was then shaped intraoperatively and enveloped in the harvested DTF before suturing it into the NSP. Safety (primary outcome) was assessed by the number of serious adverse reactions (SAR) until 12 months. Secondary outcomes included feasibility, assessed by surgical graft manipulation, and efficacy, assessed using subjective scoring (nasal obstruction symptom evaluation, NOSE, and visual analog scale, VAS, scores) and objective breathing function tests. Structural closure of NSP after 12 months was defined using endoscopy and computed tomography (CT) scans.
NSP treatment by N-TEC implantation was safe and feasible, as no SAR and no challenge in graft manipulation was recorded for any of the patients. One year postoperative, subjective scoring improved in all patients, unless already optimal (average improvement of 23 and 28.6 points out of 100, respectively, for NOSE and VAS scores). Objective respiratory function overall confirmed - with the exception of one case - the observations above (average improvement of 172 ml/s). NSP were closed and the mucosae completely healed in three patients.
Autologous N-TEC is a valid treatment for NSP and warrants further clinical tests.
本I期临床试验评估了自体鼻软骨细胞组织工程软骨（N-TEC）用于鼻中隔穿孔（NSP）功能修复的情况。
治疗NSP最广泛使用的技术，即聚二氧杂环己酮（PDS）板联合颞深筋膜（DTF）移植的插入式移植，在患者满意度和翻修率方面仍不尽人意。
患者（n = 5，均为女性，年龄范围：23 - 54岁）患有直径0.5 - 2.0厘米的NSP。N-TEC通过将自体鼻中隔软骨细胞扩增并3D培养到Chondro-Gide胶原膜中制成。然后在术中将N-TEC塑形，并包裹在采集的DTF中，再缝合到NSP处。通过直至12个月时严重不良反应（SAR）的数量评估安全性（主要结局）。次要结局包括可行性（通过手术移植物操作评估）和疗效（使用主观评分（鼻塞症状评估，NOSE，和视觉模拟量表，VAS，评分）以及客观呼吸功能测试评估）。12个月后NSP的结构闭合情况通过内窥镜检查和计算机断层扫描（CT）扫描确定。
植入N-TEC治疗NSP是安全可行的，因为所有患者均未记录到SAR，且移植物操作无困难。术后一年，所有患者的主观评分均有所改善，除非已达到最佳状态（NOSE和VAS评分分别平均提高100分中的23分和28.6分）。除1例患者外，客观呼吸功能总体证实了上述观察结果（平均提高172毫升/秒）。3例患者的NSP闭合，黏膜完全愈合。
自体N-TEC是治疗NSP的有效方法，值得进一步进行临床试验。
