PDF(Pubmed)
Abstract：
Early wound intervention and closure is critical for reducing infection and improving aesthetic and functional outcomes for patients with acute burn wounds and nonthermal full-thickness skin defects. Treatment of partial-thickness burns or full-thickness injuries with autologous skin cell suspension (ASCS) achieves robust wound closure while limiting the amount of donor skin compared with standard autografting. A Next Generation Autologous Cell Harvesting Device (NG-ACHD) was developed to standardize the preparation process for ASCS to ensure biological attributes are obtained known to correlate with well-established safety and performance data. This study compared ASCS prepared using the NG-ACHD and ACHD following the manufacturer\'s guidance, evaluating cellular yields, viability, apoptotic activity, aggregates, phenotypes and functional capacity. Non-inferiority was established for all biological attributes tested and comparable healing trajectories were demonstrated using an in vitro skin regeneration model. In addition to standardization, the NG-ACHD also provides workflow efficiencies with the potential to decrease training requirements and increase the ease of incorporation and utilization of ASCS in clinical practice.
摘要：
对于患有急性烧伤伤口和非热全层皮肤缺损的患者，早期伤口干预和闭合对于减少感染并改善美学和功能结果至关重要。与标准自体移植相比，使用自体皮肤细胞悬液（ASCS）治疗部分厚度烧伤或全厚度损伤可实现牢固的伤口闭合，同时限制供体皮肤的数量。开发了下一代自体细胞收获装置（NG-ACHD）以标准化ASCS的制备过程，以确保已知获得的生物学属性与完善的安全性和性能数据相关。本研究比较了按照制造商的指导使用NG-ACHD和ACHD制备的ASCS，评估细胞产量，生存能力，凋亡活性，骨料,表型和功能能力。为测试的所有生物学属性建立了非劣效性，并使用体外皮肤再生模型证明了可比较的愈合轨迹。除了标准化，NG-ACHD还提供了工作流程的效率，有可能降低培训要求，并增加ASCS在临床实践中的合并和利用的便利性。
