Self-regulating novel iron oxide nanoparticle-based magnetic hyperthermia in swine: biocompatibility, biodistribution, and safety assessments

Kraus, Sarah; Rabinovitz, Ricarina; Sigalov, Ekaterina; Eltanani, Moshe; Khandadash, Raz; Tal, Cheri; Rivlin, Ofra; Sharaga, Eddie; Rukenstein, Pazit; Cohen-Erner, Moshe; Nyska, Abraham; Siman-Tov, Yariv; Shalev, Ofer

doi:10.1007/s00204-022-03314-1

Cited by 3 publications

(5 citation statements)

References 44 publications

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“…The Sarah Nanotechnology System is a medical device developed by New Phase Ltd. to treat stage IV metastatic solid tumors through the delivery of thermal energy to malignant cells, thereby causing hyperthermic cancer cell death at sub-ablative temperatures [19,20]. The system involves two main components, MNPs named Sarah nanoparticles (SaNPs) and an Electromagnetic Induction System (EIS).…”

Section: Methodsmentioning

confidence: 99%

“…The objective of the current study is to present, for the first time, a clinically validated computational model for temperature distribution inside the body of human patients exposed to MNH using a novel Electromagnetic Induction System (EIS) manufactured by New Phase Ltd. (Petah Tikva, Israel). The predictive model has been validated by clinical data obtained from a Phase I feasibility clinical study (MOH_2022-09-18_012060) [18], conducted in patients with stage IV solid tumors who signed an informed consent form and were treated with escalating doses of MNPs according to the NOAEL [19] criteria and AMF irradiation, to evaluate the safety of the system, which operates well above the Atkinson-Brezovich limit. Nevertheless, the model can also be used for treatment planning once a validated model for the tumor heating rate of the injected MNPs [19] is integrated into the computational calculations.…”

Section: Introductionmentioning

confidence: 99%

“…The predictive model has been validated by clinical data obtained from a Phase I feasibility clinical study (MOH_2022-09-18_012060) [18], conducted in patients with stage IV solid tumors who signed an informed consent form and were treated with escalating doses of MNPs according to the NOAEL [19] criteria and AMF irradiation, to evaluate the safety of the system, which operates well above the Atkinson-Brezovich limit. Nevertheless, the model can also be used for treatment planning once a validated model for the tumor heating rate of the injected MNPs [19] is integrated into the computational calculations.…”

Section: Introductionmentioning

confidence: 99%

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A Validated Methodological Approach to Prove the Safety of Clinical Electromagnetic Induction Systems in Magnetic Hyperthermia

Rouni,

Shalev,

Tsanidis

et al. 2024

Cancers

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The present study focuses on the development of a methodology for evaluating the safety of MNH systems, through the numerical prediction of the induced temperature rise in superficial skin layers due to eddy currents heating under an alternating magnetic field (AMF). The methodology is supported and validated through experimental measurements of the AMF’s distribution, as well as temperature data from the torsos of six patients who participated in a clinical trial study. The simulations involved a computational model of the actual coil, a computational model of the cooling system used for the cooling of the patients during treatment, and a detailed human anatomical model from the Virtual Population family. The numerical predictions exhibit strong agreement with the experimental measurements, and the deviations are below the estimated combined uncertainties, confirming the accuracy of computational modeling. This study highlights the crucial role of simulations for translational medicine and paves the way for personalized treatment planning.

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Section: Methodsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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A Validated Methodological Approach to Prove the Safety of Clinical Electromagnetic Induction Systems in Magnetic Hyperthermia

Rouni,

Shalev,

Tsanidis

et al. 2024

Cancers

Self Cite

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“…Clearance of SaNPs showed a dose and time-dependent manner, which was predominantly eliminated through feces. Importantly, the SaNPs selectively accumulated in tumor tissue and regulated temperature by themselves when exposed to AMF [ 40 ]. Safety and biocompatibility of Maghemite/poly ( d , l -lactide-co-glycolide)/chitosan NPs (γ-Fe 2 O 3 /PLGA/CS) were assessed in BALB/c mice.…”

Section: Applications Of Ionps In Animal Modelsmentioning

confidence: 99%

Recent trends in preparation and biomedical applications of iron oxide nanoparticles

Meng,

Shi,

Zhu

et al. 2024

J Nanobiotechnol

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The iron oxide nanoparticles (IONPs), possessing both magnetic behavior and semiconductor property, have been extensively used in multifunctional biomedical fields due to their biocompatible, biodegradable and low toxicity, such as anticancer, antibacterial, cell labelling activities. Nevertheless, there are few IONPs in clinical use at present. Some IONPs approved for clinical use have been withdrawn due to insufficient understanding of its biomedical applications. Therefore, a systematic summary of IONPs’ preparation and biomedical applications is crucial for the next step of entering clinical practice from experimental stage. This review summarized the existing research in the past decade on the biological interaction of IONPs with animal/cells models, and their clinical applications in human. This review aims to provide cutting-edge knowledge involved with IONPs’ biological effects in vivo and in vitro, and improve their smarter design and application in biomedical research and clinic trials. Graphical Abstract

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“…Indeed, in these systems, the control of temperature must be very precise to avoid degradation of biocatalytic component itself. In this view, application of SRMH represents a very interesting possibility, allowing to carefully control the local temperature (Kraus et al., 2022; Torres‐Herrero et al., 2023).…”

Section: Future Perspectivesmentioning

confidence: 99%

Biocatalyst immobilization on magnetic nano‐architectures for potential applications in condensation reactions

Papatola,

Slimani,

Peddis

et al. 2024

Microbial Biotechnology

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In this review article, a perspective on the immobilization of various hydrolytic enzymes onto magnetic nanoparticles for synthetic organic chemistry applications is presented. After a first part giving short overview on nanomagnetism and highlighting advantages and disadvantages of immobilizing enzymes on magnetic nanoparticles (MNPs), the most important hydrolytic enzymes and their applications were summarized. A section reviewing the immobilization techniques with a particular focus on supporting enzymes on MNPs introduces the reader to the final chapter describing synthetic organic chemistry applications of small molecules (flavour esters) and polymers (polyesters and polyamides). Finally, the conclusion and perspective section gives the author's personal view on further research discussing the new idea of a synergistic rational design of the magnetic and biocatalytic component to produce novel magnetic nano‐architectures.

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Self-regulating novel iron oxide nanoparticle-based magnetic hyperthermia in swine: biocompatibility, biodistribution, and safety assessments

Cited by 3 publications

References 44 publications

A Validated Methodological Approach to Prove the Safety of Clinical Electromagnetic Induction Systems in Magnetic Hyperthermia

A Validated Methodological Approach to Prove the Safety of Clinical Electromagnetic Induction Systems in Magnetic Hyperthermia

Recent trends in preparation and biomedical applications of iron oxide nanoparticles

Biocatalyst immobilization on magnetic nano‐architectures for potential applications in condensation reactions

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