Importance Vascular injuries require urgent repair to minimize loss of limb and life. Standard revascularization relies on autologous vein or synthetic grafts, but alternative options are needed when adequate vein is not feasible and when clinical conditions preclude safe use of synthetic materials. Objective To evaluate the performance of the acellular tissue engineered vessel (ATEV) in the repair of arterial injuries. Design, Setting, and Participants Two open-label, single-arm, nonrandomized clinical trials, including 1 prospective civilian study (CLN-PRO-V005 [V005]) and 1 retrospective observational study in a war zone (CLN-PRO-V017 [V017]), were conducted from September 2018 to January 2024 (follow-up ongoing) at 19 level 1 trauma centers in the US and Israel and 5 frontline hospitals in Ukraine. Patients had vascular injury, no autologous vein available for emergent revascularization, and risk factors for wound infection. Data were analyzed from September 2023 to January 2024. Intervention The ATEV is a bioengineered vascular conduit grown from human vascular cells, available off the shelf, and implantable without immunosuppression. Main Outcomes and Measures Primary patency at day 30 was the primary outcome. Secondary outcomes included limb salvage, graft infection, and patient survival. A systematic literature review identified synthetic graft benchmarks in the treatment of arterial trauma for the same end points. Results The V005 and V017 studies evaluated 69 and 17 patients, respectively, and included 51 in V005 and 16 in V017 with noniatrogenic arterial injuries of the extremities. The majority were male (V005, 38 [74.5%]; V017, 16 [100%]), the mean (SD) ages were similar (V005, 33.5 [13.6] years; V017, 34.2 [9.0] years), and the mean (SD) Injury Severity Scores were similar (V005, 20.8 [10.5]; V017, 20.1 [18.9]). Penetrating injuries dominated (V005, 29 patients [56.9%]; V017, 14 patients [87.5%]). At day 30 for the V005 and V017 trials, respectively, ATEV primary patency was 84.3% (95% CI, 72.0%-91.8%) and 93.8% (95% CI, 71.7%-98.9%); secondary patency was 90.2% (95% CI, 79.0%-95.7%) and 93.8% (95% CI, 71.7%-98.9%); amputation rate was 9.8% (95% CI, 4.3%-21.0%) and 0% (95% CI, 0.0%-19.4%); ATEV infection rate was 2.0% (95% CI, 0.4%-10.3%) and 0% (95% CI, 0.0%-19.4%); and death rate was 5.9% (95% CI, 2.0%-15.9%) and 0% (95% CI, 0.0%-19.4%) (no deaths attributed to the ATEV). Day 30 synthetic graft benchmarks were as follows: secondary patency, 78.9%; amputation, 24.3%; infection, 8.4%; and death, 3.4%. Conclusions and Relevance Results of 2 single-arm trials in civilian and real-world military settings suggest that the ATEV provides benefits in terms of patency, limb salvage, and infection resistance. Comparing ATEV outcomes with synthetic graft benchmarks demonstrates improved outcomes in the treatment of acute vascular injuries of the extremities. Trial Registration ClinicalTrials.gov Identifiers: NCT03005418, NCT05873959.

中文翻译：

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用于修复血管损伤的生物工程人体动脉。


重要性 血管损伤需要紧急修复，以尽量减少肢体和生命的损失。标准的血运重建依赖于自体静脉或合成移植物，但当足够的静脉不可行且临床条件无法安全使用合成材料时，需要替代选择。目的 评价脱细胞组织工程血管 （ATEV） 在动脉损伤修复中的性能。设计、设置和参与者 2018 年 9 月至 2024 年 1 月在美国和以色列的 19 个 1 级创伤中心以及乌克兰的 5 家一线医院进行了两项开放标签、单臂、非随机临床试验，包括 1 项前瞻性平民研究 （CLN-PRO-V005 [V005]）和 1 项战区回顾性观察研究 （CLN-PRO-V017 [V017]）（随访正在进行中）。患者有血管损伤，没有可用于紧急血运重建的自体静脉，以及伤口感染的危险因素。数据分析时间为 2023 年 9 月至 2024 年 1 月。干预 ATEV 是一种由人类血管细胞生长的生物工程血管导管，现成可用，无需免疫抑制即可植入。主要结局和指标 第 30 天的主要通畅率是主要结局。次要结局包括保肢、移植物感染和患者生存率。一项系统文献综述确定了合成移植物治疗相同终点的动脉创伤基准。结果 V005 和 V017 研究分别评估了 69 例和 17 例患者，包括 V005 中的 51 例和 V017 中的 16 例肢体非医源性动脉损伤患者。大多数是男性 （V005， 38 [74.5%];V017,16 [100%]），平均 （SD） 年龄相似 （V005,33.5 [13.6] 岁;V017,34.2 [9.0] 岁），平均 （SD） 损伤严重程度评分相似 （V005， 20.8 [10.5];V017， 20.1 [18.9]）。穿透伤占主导地位 （V005,29 名患者 [56.9%];V017,14 名患者 [87.5%]）。在 V005 和 V017 试验的第 30 天，ATEV 一期通畅率分别为 84.3% （95% CI，72.0%-91.8%） 和 93.8% （95% CI，71.7%-98.9%）;二次通畅率为 90.2% （95% CI，79.0%-95.7%） 和 93.8% （95% CI，71.7%-98.9%）;截肢率分别为 9.8% （95% CI， 4.3%-21.0%） 和 0% （95% CI， 0.0%-19.4%）;ATEV 感染率分别为 2.0% （95% CI， 0.4%-10.3%） 和 0% （95% CI， 0.0%-19.4%）;死亡率为 5.9% （95% CI，2.0%-15.9%） 和 0% （95% CI，0.0%-19.4%） （无归因于 ATEV 的死亡）。第 30 天合成移植物基准如下：二级通畅率，78.9%;截肢，24.3%;感染，8.4%;死亡，3.4%。结论和相关性 在民用和真实世界军事环境中进行的 2 项单臂试验的结果表明，ATEV 在通畅、保肢和感染抵抗方面具有益处。将 ATEV 结果与合成移植物基准进行比较表明，四肢急性血管损伤的治疗结果有所改善。试验注册 ClinicalTrials.gov 标识符：NCT03005418、NCT05873959。