Pathways to translation for nanomedicine in nephrology.

IF 4.6 2区 医学 Q1 UROLOGY & NEPHROLOGY
Clinical Kidney Journal Pub Date : 2025-09-18 eCollection Date: 2025-09-01 DOI:10.1093/ckj/sfaf192
Zoe Schoales, Pratyusha Ghosh, Anastasiia Vasylaki, Edgar A Jaimes, Ryan Williams
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引用次数: 0

Abstract

Kidney diseases are a substantial worldwide health burden, with high mortality and increasing incidence. Despite their prevalence, substantial gaps remain in the clinic in both diagnostics and therapeutics. Many novel treatments have failed in clinical trials or fallen out of use in the clinic due to side effects and poor efficacy, in large part due to poor therapeutic profiles in the kidney. Nanomedicines have begun to emerge as a potentially promising diagnostic or therapeutic delivery system. Based on their physicochemical properties, such as size, shape, surface chemistry, and so on, some nanotechnologies can target the kidneys. However, as of yet, no kidney-specific nanomedicines have reached clinical translation. While the field of renal nanomedicine is in its early stages and growing, some potential obstacles to translation include poor preclinical models, challenges in manufacturing scale-up, clinical trial design and the cost of translation. Here, we overview the current state of the kidney-targeting nanomedicine field and outline a potential framework for clinical translation. We focus on the paths of US Food and Drug Administration- approved nanomedicines and suggestions from other nanomedicine fields to inform our key considerations for translational success. We also highlight the importance of academic and clinical collaboration with industry and federal regulators. Several investigational technologies are just now at the cusp of scaling towards the clinic and we therefore aim to support this momentum for improving the lives of patients with kidney diseases.

纳米医学在肾病学中的转化途径。
肾脏疾病是一个巨大的全球健康负担,具有高死亡率和不断增加的发病率。尽管发病率很高,但在临床诊断和治疗方面仍存在巨大差距。由于副作用和疗效差,许多新的治疗方法在临床试验中失败或在临床中退出使用,这在很大程度上是由于肾脏治疗效果不佳。纳米药物已经开始成为一种有潜力的诊断或治疗递送系统。基于它们的物理化学性质,如大小、形状、表面化学等,一些纳米技术可以针对肾脏。然而,到目前为止,还没有针对肾脏的纳米药物达到临床转化。虽然肾脏纳米医学领域处于早期阶段和发展阶段,但转化的一些潜在障碍包括临床前模型不佳、生产规模的挑战、临床试验设计和转化成本。在这里,我们概述了肾脏靶向纳米医学领域的现状,并概述了临床转化的潜在框架。我们关注美国食品和药物管理局批准的纳米药物的路径以及来自其他纳米医学领域的建议,以告知我们转化成功的关键考虑因素。我们还强调了与行业和联邦监管机构进行学术和临床合作的重要性。一些研究技术目前正处于临床推广的尖端,因此我们的目标是支持这一势头,以改善肾脏疾病患者的生活。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
Clinical Kidney Journal
Clinical Kidney Journal Medicine-Transplantation
CiteScore
6.70
自引率
10.90%
发文量
242
审稿时长
8 weeks
期刊介绍: About the Journal Clinical Kidney Journal: Clinical and Translational Nephrology (ckj), an official journal of the ERA-EDTA (European Renal Association-European Dialysis and Transplant Association), is a fully open access, online only journal publishing bimonthly. The journal is an essential educational and training resource integrating clinical, translational and educational research into clinical practice. ckj aims to contribute to a translational research culture among nephrologists and kidney pathologists that helps close the gap between basic researchers and practicing clinicians and promote sorely needed innovation in the Nephrology field. All research articles in this journal have undergone peer review.
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