Evaluation of the clinical impact of repeat application of hydrogel-forming microneedle array patches
Evaluation of the clinical impact of repeat application of hydrogel-forming microneedle array patches
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DOI：
10.1007/s13346-020-00727-2
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发表时间：
2020-02-26
影响因子：
5.4
通讯作者：
Donnelly, Ryan F.
中科院分区：
文献类型：
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作者：
Al-Kasasbeh, Rehan;Brady, Aaron J.;Donnelly, Ryan F.
水凝胶形成微针阵列贴片（MAP）已被提议作为可行的临床工具，用于患者监测目的，提供了一种替代传统的样本采集方法，如静脉穿刺和皮内采样。他们还正在接受非黑色素瘤皮肤癌管理方面的调查。与药物或疫苗递送相反，当仅需要少量MAP应用时，用于取样目的或用于肿瘤根除的水凝胶MAP将需要定期重复应用。因此，本研究旨在解决MAP开发的关键转化方面之一，即患者安全性。我们首次在人类志愿者中证明，重复MAP应用和佩戴不会导致皮肤反应延长或皮肤屏障功能延长。重要的是，在该固定研究期间，记录了炎症（C反应蛋白（CRP）;肿瘤坏死因子-α（TNF-α））;感染（白细胞介素-1 β（IL-1 β））;过敏（免疫球蛋白E（IgE））和免疫力（免疫球蛋白G（IgG））的特定全身生物标志物的浓度。在研究过程中，未记录到高于正常、记录的成人范围的生物标志物浓度，表明在志愿者中未引发全身反应。基于这项研究的结果，这有助于强调我们的水凝胶MAP的安全性，我们正在积极努力使我们的MAP技术作为医疗器械获得CE认证。
Hydrogel-forming microneedle array patches (MAPs) have been proposed as viable clinical tools for patient monitoring purposes, providing an alternative to traditional methods of sample acquisition, such as venepuncture and intradermal sampling. They are also undergoing investigation in the management of non-melanoma skin cancers. In contrast to drug or vaccine delivery, when only a small number of MAP applications would be required, hydrogel MAPs utilised for sampling purposes or for tumour eradication would necessitate regular, repeat applications. Therefore, the current study was designed to address one of the key translational aspects of MAP development, namely patient safety. We demonstrate, for the first time in human volunteers, that repeat MAP application and wear does not lead to prolonged skin reactions or prolonged disruption of skin barrier function. Importantly, concentrations of specific systemic biomarkers of inflammation (C-reactive protein (CRP); tumour necrosis factor-alpha (TNF-alpha)); infection (interleukin-1 beta (IL-1 beta); allergy (immunoglobulin E (IgE)) and immunity (immunoglobulin G (IgG)) were all recorded over the course of this fixed study period. No biomarker concentrations above the normal, documented adult ranges were recorded over the course of the study, indicating that no systemic reactions had been initiated in volunteers. Building upon the results of this study, which serve to highlight the safety of our hydrogel MAP, we are actively working towards CE marking of our MAP technology as a medical device.