Carlos A. Mora, Laurine Rijsbergen, Jan Waskowski, Gaelle Clermont, Florian Dingreville, Chandrashekara Vishwanath, Rajesh Karunanithi, Alexander Gogos, Jean-Claude Metzger, Manuel Baumgartner, Joerg C. Schefold, Inge K. Herrmann
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引用次数: 0
Abstract
Direct selective removal of disease-etiologic factors from blood is a potentially lifesaving intervention in multiple medical conditions (including sepsis). Magnetic separation-based blood purification represents a selective therapeutic strategy addressing limitations of conventional extracorporeal devices. However, GLP-compliant biological safety data demonstrating its separation efficiency and biocompatibility remain lacking. Here, we introduce an extracorporeal blood purification system (HemoSystem) designed to remove target compounds using injectable, magnetic nanoparticles (HemoBeads) comprising a nonoxidic iron core encapsulated by a functionalized graphene/polymer shell. HemoBeads are surface-modified with compound-specific binding moieties and are administered continuously into the extracorporeal circuit to capture target molecules before being magnetically extracted from the blood. We present ISO 10993-compliant biocompatibility evaluations alongside preclinical studies in pig and rat models to assess: (i) the operational safety of the extracorporeal system, (ii) the efficiency of HemoBead removal prior to blood reinfusion, and (iii) the systemic toxicity, biodistribution, and long-term fate of nanoparticles under exaggerated exposure conditions simulating a worst-case slip-through scenario. The results show that the HemoSystem appears safe and is easily integrated into clinical procedures. No clinically significant alterations in hemodynamic, hematological, or biochemical parameters were observed. Nanoparticles are efficiently (≥99.9%) extracted from the blood at a blood flow rate of 6 L h−1. The beads did not accumulate in organs such as brain or heart and are gradually eliminated without pathological alterations. Our findings support the preclinical biological safety and translational feasibility of the HemoSystem as a next-generation hemoperfusion platform for targeted extracorporeal removal of disease-etiologic molecules from the bloodstream.
从血液中直接选择性去除疾病病因是一种潜在的挽救多种医疗条件（包括败血症）的干预措施。基于磁分离的血液净化代表了一种选择性治疗策略，解决了传统体外装置的局限性。然而，符合glp的生物安全性数据证明其分离效率和生物相容性仍然缺乏。在这里，我们介绍了一种体外血液净化系统（haemsystem），旨在使用可注射的磁性纳米颗粒（hembeads）去除目标化合物，该纳米颗粒由非氧化铁核包裹在功能化石墨烯/聚合物外壳中。血液微珠是用化合物特异性结合部分进行表面修饰的，在从血液中磁力提取之前，连续地进入体外回路以捕获目标分子。我们提出了符合ISO 10993标准的生物相容性评估，并在猪和大鼠模型中进行了临床前研究，以评估：(i)体外系统的操作安全性，（ii）血液回输前去除hembead的效率，以及（iii）在模拟最坏情况的最坏情况下夸大暴露条件下纳米颗粒的全身毒性，生物分布和长期命运。结果表明，血液系统似乎是安全的，很容易集成到临床程序。血流动力学、血液学或生化参数未见临床显著改变。当血流量为6 L h−1时，纳米颗粒被有效地（≥99.9%）从血液中提取出来。这些小珠不会在大脑或心脏等器官中积聚，并在没有病理改变的情况下逐渐消除。我们的研究结果支持了血液系统作为下一代血液灌流平台的临床前生物学安全性和转化可行性，用于从血液中靶向体外去除疾病病原分子。
期刊介绍：
Advanced NanoBiomed Research will provide an Open Access home for cutting-edge nanomedicine, bioengineering and biomaterials research aimed at improving human health. The journal will capture a broad spectrum of research from increasingly multi- and interdisciplinary fields of the traditional areas of biomedicine, bioengineering and health-related materials science as well as precision and personalized medicine, drug delivery, and artificial intelligence-driven health science.
The scope of Advanced NanoBiomed Research will cover the following key subject areas:
▪ Nanomedicine and nanotechnology, with applications in drug and gene delivery, diagnostics, theranostics, photothermal and photodynamic therapy and multimodal imaging.
▪ Biomaterials, including hydrogels, 2D materials, biopolymers, composites, biodegradable materials, biohybrids and biomimetics (such as artificial cells, exosomes and extracellular vesicles), as well as all organic and inorganic materials for biomedical applications.
▪ Biointerfaces, such as anti-microbial surfaces and coatings, as well as interfaces for cellular engineering, immunoengineering and 3D cell culture.
▪ Biofabrication including (bio)inks and technologies, towards generation of functional tissues and organs.
▪ Tissue engineering and regenerative medicine, including scaffolds and scaffold-free approaches, for bone, ligament, muscle, skin, neural, cardiac tissue engineering and tissue vascularization.
▪ Devices for healthcare applications, disease modelling and treatment, such as diagnostics, lab-on-a-chip, organs-on-a-chip, bioMEMS, bioelectronics, wearables, actuators, soft robotics, and intelligent drug delivery systems.
with a strong focus on applications of these fields, from bench-to-bedside, for treatment of all diseases and disorders, such as infectious, autoimmune, cardiovascular and metabolic diseases, neurological disorders and cancer; including pharmacology and toxicology studies.
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